Senior Scientist
Senior Scientist Job 9 miles from East Orange
Title: Senior Scientist
Work Schedule: Mon -- Fri, Business Hours
Duration: 06+ Months
Pay rate: $50 - $53/hr on W2
Hybrid role
Hybrid = 2 days onsite 1 week, 3 days onsite the next week, subject to change based on the needs of the business.
Top Must Have's for candidate to be Considered for this role:
Excellent knowledge of evaluating data using statistics and statistical tools, to make data driven decisions.
Proficiency in major statistical software packages and programming languages (e.g., R, JMP, MINITAB, or SAS). JMP software preferred.
Summary Report creation/Review in support of CPV (Continuous Process Verification) and APQR (Annual Product Quality Review).
Must be detail oriented and proven track record of impeccable time management, to meet timelines.
Possess strong verbal/written communication skills to enable working with internal/external parties and/or collaborating with cross-functional teams.
Job Description:
The Senior Scientist of Biostatistics is a member of the MSAT team, with focus in CPV (Continued Process Verification) and APQR (Annual Product Quality Review) reporting.
Position Summary:
The incumbent will support the monitoring/trending of production and release testing parameters, in support of product of personalized cell therapy products for both global commercial and clinical trial supply.
The Incumbent will trend CPV parameters, including but not limited to Manufacturing process parameters and Quality Control Release attributes for the MSAT organization, to support the Summit, NJ Cell Therapy facility.
The purpose of a CPV program is to provide evidence that a process is running under a state of control. The incumbent will monitor/trend, alerting stakeholders of any drifts and supporting the data reporting of process parameters to the global MSAT organization, while meeting established timelines. The CPV program includes supporting the APQR, as required by regulatory agencies. The incumbent will support the CPV and APQR reports and approvals.
The organization being supported is a 24x7x365 manufacturing facility. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Summit, NJ Building S12. This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and MSAT.
Duties/Responsibilities:
Provides support to maintain the site Statistical Process Control (SPC) program, manufacturing performance trending and reporting.
Provide multivariate analysis (MVA) modeling for improved process understanding and robustness
Continuously monitor CPV parameters, evaluate Statistical Alert Events (SAEs), and take needed actions.
Collaborate and support investigations by providing data and analysis
Meet CPV and APQR timelines
Establish and support predictive process monitoring analytics
Supporting any proactive initiatives or investigations related to drift in product performance
Represent the site MSAT CPV team in cross-functional forums
Performing review and approval of site documents within the scope of CPV and APQR
Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness; actively supporting regulatory inspections
Interacting with other teams including Operational Excellence, PMO (Project Management Organization), site MSAT, Global MSAT, Quality Assurance, Process Support/Engineering and Manufacturing Support, Manufacturing Operations, Supply Chain Operations Staying current with industry trends and BMS standards and participating in best practice forums consistent with function responsibilities
Identify key Opex opportunities, using data driven evaluations
Qualifications Specific Knowledge, Skills, Abilities:
Excellent knowledge of evaluating data using statistics and statistical tools, to make data driven decisions.
Proficiency in major statistical software packages and programming languages (e.g., R, JMP, MINITAB, or SAS). JMP software preferred.
Must be detail oriented and proven track record of impeccable time management, to meet timelines.
Possess strong verbal/written communication skills to enable working with internal/external parties and/or collaborating with cross-functional teams.
Expert knowledge of cGMP's and multi-national biopharmaceutical/cell therapy regulations.
Experience of facility/clean room design, process, equipment, automation, and validation.
Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities.
Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.
Experience with Operational Excellence and Lean Manufacturing
Education, Experience, Licenses, Certificates:
Bachelor's Degree required (science or engineering is preferred); Graduate or higher-level Degree is preferred 8 or more years of work experience in the biopharmaceutical or related
Industry 8 or more years of manufacturing support or related experience in the biopharmaceutical industry
Experience in CPV and/or APQR reporting preferred. May be substituted for relevant experience in monitoring/trending performance of Quality attributes
Experience in cell therapy, biologics, or vaccine manufacturing/support required
Experience with Operational Excellence and Lean Manufacturing is a plus
(2025 New Grads)-6G Research Scientist
Senior Scientist Job 19 miles from East Orange
About the Company - The 6G Wireless Research Center at MediaTek US focusses on research and innovation aiming at creating technological breakthroughs and differentiation in next generation wireless cellular technologies, standards, and future generation of products. By joining the research center you will have the opportunity to invent the future focusing your research on laying the foundation of the revolutionary 6G communication and computing technologies, devices, and systems.
About the Role - The applicant must have sustained and demonstrated research accomplishments focused on pushing the frontiers of cutting-edge technologies, development and application of state-of-the-art theory, intelligent algorithms, analytical and simulation tools, as well as Proof of Concept (PoC) demonstrators in the field of modern broadband wireless communication technologies, wireless networking protocols and architectures, and emerging AI/ML techniques.
She/he must be able to work with colleagues from various fields in identifying, formulating, and solving new research problems to address the grand challenges of the emerging 6G advanced communications era, which is now in definition mode. The applicant must have a very strong research mindset, possess analytical and exponential thinking, and be driven by the passion for solving unsolved complex problems. The successful candidate will be able to identify, lead and conduct advanced research activities as related to 6G native AI network architecture to address some of the most challenging research problems in the context of 6G paradigm. Furthermore, she/he will be armed with the level of expertise needed to help ensure that MediaTek's future generation products have the desired features to succeed in the marketplace.
Qualifications - Ph.D. student who graduated in December 2024 or expects to graduate in 2025 with major in Electrical Engineering, Electrical and Computer Engineering, Computer Science, or related fields
Required Skills
Significant research experience in industrial and/or academic labs
Ability to innovate and create top-quality research assets of prime relevance to 6G native AI network architectures
Sustained and demonstrated research accomplishments focused on pushing the frontiers of cutting-edge technologies, development, and application of state-of-the-art theory in the field of modern wireless communication technologies, wireless networking protocols and architectures, and emerging AI/ML techniques
Strong innovation track record across multiple wireless generations of technologies, including 4G, 5G and 6G. This includes high quality publications in top journals and conferences, patents, intelligent algorithms, analytical/simulation tools, research PoCs as proof of high-quality research ideas
Strong collaborative research skills with industrial and academic partners
Strong hands-on expertise (analytical modeling, simulation of complex systems, mathematical analysis, AI/ML systems, algorithm design, building top-quality research PoCs)
Strong expertise in evolving wireless networking architectures (sensing, computing, communicating), modern broadband wireless access technologies, AI/ML for cellular, wireless communication systems across layers (from Physical to Application layers), cross-layer protocol design and optimization, security, and privacy
Mature research skills in AI/ML, at least in one of the areas related to: Fundamentals of ML, On-Device ML, Privacy Preserving ML, AI for Autonomous Systems, Augmented Reality and Computer Vision, AI for Industrial Intelligence
Excellent verbal and written communication skills
MediaTek is an Equal Opportunity Employer that is committed to inclusion and diversity to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.
Research And Development Scientist
Senior Scientist Job 17 miles from East Orange
Coatings R&D Scientist
A fast growing PE-backed company in the Advanced Materials manufacturing space is looking for a Coatings R&D Scientist to develop innovative coatings, dispersions, and chemical formulations for diverse applications, including industrial lubricants, high-temperature release, conductive, and corrosion-resistant coatings. This is a hands-on, fast-paced role where you'll lead research initiatives, collaborate with cross-functional teams, and contribute to groundbreaking product development efforts at a state-of-the-art R&D facility.
Responsibilities Include:
Designing and formulating novel coatings and dispersions tailored for various industrial applications.
Conducting experiments, analyzing data, and providing clear insights and next steps.
Leading a safe, clean, and well-organized laboratory environment.
Guiding and supervising junior chemists in performing experiments and presenting results.
Developing standard operating procedures (SOPs) and ensuring compliance with safety protocols.
Researching and testing new raw materials to enhance existing products or create new ones.
Identifying and evaluating advanced laboratory instrumentation to expand R&D capabilities.
Presenting data and findings to internal stakeholders and collaborating with marketing and new business development teams to align research with market opportunities.
Supporting production scale-up at manufacturing plants and ensuring a seamless transition from R&D to commercialization.
Required Skills and Experience:
Education: Ph.D., MS, or BS in Chemistry, Chemical Engineering, Materials Engineering, or related fields.
Experience: 3-5+ years in industrial chemical-based manufacturing: coatings, sealants, adhesives, or dispersions.
Expertise in rheology, coating application techniques, adhesion principles, and DOE (Design of Experiments).
Strong data analysis and presentation skills, with proficiency in statistical tools like Excel and DOE software.
Effective communication skills to interface with cross-functional teams and stakeholders, including C-suite executives.
Adaptability and problem-solving skills to thrive in a fast-paced, growth-oriented environment.
What the role Offers:
A chance to work in a newly built, state-of-the-art R&D facility equipped with cutting-edge technology.
A culture focused on innovation, collaboration, and transparency, supported by a growing, forward-thinking organization.
Opportunities to engage in exciting market development efforts, particularly in high-temperature coatings, aluminum applications, and conductive coatings for thermal and electrical use.
Physical Requirements: This onsite position requires the ability to stand for extended periods and occasionally lift up to 50 lbs.
Salary and Benefits:
The salary range for this role takes into account the wide range of factors that are considered in making compensation decisions, including but not limited to skill set; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. It is not common for an individual to be hired at or near the top of the range for their role, and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the base range is $100,000.00 to $ 125,000.00 per year + 15% company performance bonus and benefits.
Senior Associate Scientist
Senior Scientist Job 19 miles from East Orange
"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".
Job Title: Senior Associate Scientist
Duration: 12 months
Pay rate: $51.97/ hr on W2
Job Description:
4-7 years experience with CAR-T cell therapy
Cellular biology techniques, flow cytometry, ELISA
Mammalian cell experience
Bench level experience, they have to be 100% lab based and looking to stay in the lab.
Cell based assays
10+ years CAR-T experience would be overqualified
Minimum bachelor's degree with 4+ years experience
Comfortable with master's degree with 2+ years' experience
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.
Biology Expertise Sought for AI Fact Checking
Senior Scientist Job 3 miles from East Orange
Outlier helps the world's most innovative companies improve their AI models by providing human feedback. Are you an experienced Biology who would like to lend your expertise to train AI models? About the opportunity: Outlier is looking for talented accounting and tax experts to help train generative artificial intelligence models This freelance opportunity is remote and hours are flexible, so you can work whenever is best for you You may contribute your expertise by…Assessing the factuality and relevance of domain-specific text produced by AI models Crafting and answering questions related to BiologyEvaluating and ranking domain-specific responses generated by AI models Examples of desirable expertise:A bachelor's or higher degree in Biology or a related subject Experience working as an Biology professional Ability to write clearly about concepts related to Biology in fluent EnglishPayment:Currently, pay rates for core project work by Biology experts range from $30 to $50 per hour USD.
Rates vary based on expertise, skills assessment, location, project need, and other factors.
For example, higher rates may be offered to PhDs.
For non-core work, such as during initial project onboarding or project overtime phases, lower rates may apply.
Certain projects offer incentive payments.
Please review the payment terms for each project.
Senior Scientist, Cardiovascular Diseases
Senior Scientist Job 16 miles from East Orange
Title:
(Senior) Scientist, Cardiovascular Diseases
Salary:
$125,000-$145,000
EPM is currently partnered with clinical stage biopharmaceutical company with an exciting pipeline that shows preclinical promise in a broad range of clinical indications. Two lead assets are currently in early phase clinical developments, and on track for further clinical development this year.
The leadership team brings over 25 years of success, with FDA-approved therapies, IPO launches, and multiple strategic biotech exits, along with deep connections across life sciences and venture ecosystems. Backed with resourceful funding and high-value partnerships in biotech and top-10 pharma, the company is well-positioned to reinvest into R&D, while advancing their current clinical pipeline in CNS and Fibrotic indications. They have identified that their platform naturally aligns with cardiovascular biology and are expanding into this area to drive the next wave of first-in-class therapies
Key Responsibilities:
Lead target discovery, identification, and validation efforts focused on cardiovascular and cardiometabolic diseases, leveraging a cutting-edge small molecule discovery platform.
Design and execute in vitro and cell-based assays to interrogate target biology, disease-relevant pathways, and compound activity across cardiovascular indications (e.g., atherosclerosis, vascular remodeling, heart failure, and fibrosis).
Collaborate cross-functionally with chemistry, translational, and clinical teams to ensure alignment between discovery biology and downstream development strategies.
Apply deep knowledge of vascular biology, endothelial dysfunction, inflammation, and metabolic signaling to guide biological validation of new targets.
Analyze and interpret complex data sets, integrating findings into broader disease biology and drug discovery programs.
Contribute to the development of the cardiovascular research strategy, incorporating new technologies, disease models, and biomarker approaches to support target prioritization and lead optimization.
Stay current with emerging science and competitive landscape in cardiovascular and cardiometabolic drug discovery, providing scientific insights to shape pipeline expansion.
Key Skills & Qualifications:
PhD in Cardiovascular Biology, Vascular Biology, Pharmacology, or a related discipline, with 3+ years of relevant industry experience(open to strong postdocs looking to transition).
Deep expertise in cardiovascular disease biology, including knowledge of vascular dysfunction, endothelial biology, cardiomyocyte biology, cardiac fibrosis, and metabolic signaling.
Hands-on experience with target discovery techniques such as:
CRISPR screening
RNA sequencing & omics data interpretation
Biochemical and cellular assays to study target function (reporter assays, phenotypic screening, pathway modulation).
Strong foundation in in vitro pharmacology- assay development, compound profiling, and mechanism-of-action studies for small molecules.
Ability to work in a highly collaborative environment, communicating effectively with medicinal chemists, translational biologists, and external partners.
Experience working within a small to mid-sized biotech environment is a plus - comfort operating in a fast-paced, evolving R&D setting.
Passion for cardiovascular discovery and desire to play a hands-on role in shaping pipeline strategy in an innovative biotech setting.
Biostatistics Senior Scientist
Senior Scientist Job 9 miles from East Orange
Work Schedule: Mon -- Fri, Business Hours
Hybrid = 2 days onsite 1 week, 3 days onsite the next week, subject to change based on the needs of the business.
The Senior Scientist of Biostatistics is a member of the MSAT team, with focus in CPV (Continued Process Verification) and APQR (Annual Product Quality Review) reporting.
Position Summary:
The incumbent will support the monitoring/trending of production and release testing parameters, in support of product of personalized cell therapy products for both global commercial and clinical trial supply.
The Incumbent will trend CPV parameters, including but not limited to Manufacturing process parameters and Quality Control Release attributes for the MSAT organization, to support the Summit, NJ Cell Therapy facility.
The purpose of a CPV program is to provide evidence that a process is running under a state of control. The incumbent will monitor/trend, alerting stakeholders of any drifts and supporting the data reporting of process parameters to the global MSAT organization, while meeting established timelines. The CPV program includes supporting the APQR, as required by regulatory agencies. The incumbent will support the CPV and APQR reports and approvals.
The organization being supported is a 24x7x365 manufacturing facility. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Summit, NJ. This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and MSAT.
This position is based in Summit, NJ. Travel up to 10% of time may be required within US.
Duties/Responsibilities:
• Provides support to maintain the site Statistical Process Control (SPC)
program, manufacturing performance trending and reporting.
• Provide multivariate analysis (MVA) modeling for improved process
understanding and robustness
• Continuously monitor CPV parameters, evaluate Statistical Alert Events
(SAEs), and take needed actions.
• Collaborate and support investigations by providing data and analysis
• Meet CPV and APQR timelines
• Establish and support predictive process monitoring analytics
• Supporting any proactive initiatives or investigations related to drift in
product performance
• Represent the site MSAT CPV team in cross-functional forums
• Performing review and approval of site documents within the scope of CPV
and APQR
• Ensuring safe and compliant cGMP operations and maintaining permanent
inspection readiness; actively supporting regulatory inspections
• Interacting with other teams including Operational Excellence, PMO (Project
Management Organization), site MSAT, Global MSAT, Quality Assurance,
Process Support/Engineering and Manufacturing Support, Manufacturing
Operations, Supply Chain Operations
• Staying current with industry trends and client standards and participating in
best practice forums consistent with function responsibilities
• Identify key Opex opportunities, using data driven evaluations
Working conditions:
• The incumbent will be required to adhere to the current client policies and
procedures.
• The incumbent will be required to gown to access classified manufacturing
areas when needed.
• This is intended to describe the general nature and level of
work being performed by the person assigned to this position. The primary
duties and responsibilities are intended to describe those functions that are
essential to the performance of this job.
• This job description does not state or imply that the above are the only duties
and responsibilities assigned to this position. There are other duties and
responsibilities that are considered incidental or secondary to the overall
purpose of this job. Employees holding this position will be required to
perform any other job-related duties as requested by management.
Qualifications Specific Knowledge, Skills, Abilities:
• Excellent knowledge of evaluating data using statistics and statistical tools, to
make data driven decisions.
• Proficiency in major statistical software packages and programming languages
(e.g., R, JMP, MINITAB, or SAS). JMP software preferred.
• Must be detail oriented and proven track record of impeccable time
management, to meet timelines.
• Possess strong verbal/written communication skills to enable working with
internal/external parties and/or collaborating with cross-functional teams.
• Expert knowledge of cGMP's and multi-national biopharmaceutical/cell
therapy regulations.
• Experience of facility/clean room design, process, equipment, automation,
and validation.
• Experience with the start-up, validation, and licensure of new
biopharmaceutical manufacturing facilities.
• Hands-on experience with single-use technologies, closed systems, and cold
chain/cryogenic technologies.
• Experience with Operational Excellence and Lean Manufacturing
Education, Experience, Licenses, Certificates:
• Bachelor's Degree required (science or engineering is preferred); Graduate
or higher-level Degree is preferred
• 8 or more years of work experience in the biopharmaceutical or related
industry
• 8 or more years of manufacturing support or related experience in the
biopharmaceutical industry
• Experience in CPV and/or APQR reporting preferred. May be substituted for
relevant experience in monitoring/trending performance of Quality
attributes
• Experience in cell therapy, biologics, or vaccine manufacturing/support
required
• Experience with Operational Excellence and Lean Manufacturing is a plus
Senior Research Scientist, Organic Synthesis Core Facility
Senior Scientist Job 16 miles from East Orange
The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue?our mission?at MSK and around the globe.
Job Description:
The Organic Synthesis Core Facility at Memorial Sloan Kettering Cancer Center is urgently looking for a PhD-level Organic/Medicinal Chemist to join our team. OSCF supports the work of both clinical and basic science colleagues by addressing their chemistry needs.
The successful candidate will be responsible for maintaining high level productivity in the lab and will require good working knowledge of contemporary organic synthesis and medicinal chemistry to support a wide range of research projects. The candidate will have the ability to independently conceive and plan efficient synthetic strategies and designing molecules. The role requires performing experiments within established timelines, and make every effort to purify and characterize products, along with maintaining detailed and accurate laboratory notebooks. Additionally, the candidate will have the ability to reconcile bench work and effectively communicate research findings through written reports, and drafting manuscripts and patent applications.
The ideal candidate should have
PhD in Organic or Medicinal Chemistry.
Excellent oral and written communication skills.
Independent problem solving skills.
Team spirit and strong interpersonal skills.
Experience running flow chemistry is highly preferred.
Experience with nucleoside and nucleotide chemistry is desirable.
Knowledge of bioconjugation techniques is a plus.
This position offers a unique opportunity in a collaborative and fast-paced environment. If you thrive in a team-oriented yet independent role, we encourage you to apply.
Application Instructions
Interested applicants should submit a cover letter, CV, an abridged overview of your accomplished synthesis or medicinal chemistry work, along with the names and contact information of at least three professional references. Please include specific examples that demonstrate your ability to work effectively in a team, as well as instances where you have shown independent problem-solving skills. Applications should be sent via email to: *******************
Additional Information
Hours: Onsite Monday - Friday, 9am - 5 pm
Pay Range: $62,985 - $110,000
Closing:
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
CMC Regulatory Scientist II
Senior Scientist Job 12 miles from East Orange
AllSTEM Connections is seeking an Associate Principal Scientist, Regulatory Affairs to work Hybrid/Onsite in Rahway, NJ.
. Possible extension/temp-to-hire.
Hourly rate is up to $75/hour.
Schedule: M-F, 8AM - 5PM. Onsite 3 days, Tues and Weds
must
be onsite, other day optional
SUMMARY:
Our confidential client is a global leader in human and animal health.
The Associate Principal Scientist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance. The Associate Principal Scientist is also responsible for the preparation and review of information required for development of regulatory CMC dossiers for new and existing commercial products
RESPONSIBILITIES:
60% to 80%:
Work independently and effectively to manage and author regulatory CMC dossiers, renewals/annual reports, variations/supplements, and responses to authority questions as required in each country in order to gain new and maintain existing product registrations.
Review technical reports and scientific information provided to support regulatory submissions
Identify potential risks and propose mitigation strategies; communicate potential regulatory issues to management, as needed.
Critically evaluate health authority questions with the respective CORA and lead the answer team of cross-functional SMEs to compile the responses in order to author and submit the responses timely to meet health authority deadlines
Actively participate on new product development teams as well as other project teams and initiatives and deliver on all assigned regulatory milestones.
10% to 20%:
Change Management Regulatory Impact Assessment: Provide regulatory assessments for post approval change proposals, filing strategies and timelines
Renewals and Geo-Expansions: Support license renewals and geo-expansion activities by supporting CORA requests for dossiers and GMP documentation
Maintain regulatory information in accordance with processes and procedures to support regulatory compliance
Continuously build and share knowledge of CMC-related global regulations and guidelines, authority expectations, as well as current industry standard, while also helping to coach others in a collaborative manner, using good communication
QUALIFICATIONS:
Education
Ph.D. with > 4 years, M.S. with > 7 years, or B.S with >10 years relevant industry experience in related R&D sciences discipline (engineering, chemistry, biological sciences, pharmacy, veterinary, regulatory)
Skills Required
Required: minimum of 2 years authoring CMC sections for regulatory submissions.
Preferred: experience and skills in a supervisory role and metrics development.
Competencies Required:
Hands on experience in R&D pharmaceutical development (formulations- development pharmaceutics, process technology, analytical method development and validation, and/or packaging development)
Experience authoring technical reports and regulatory submissions, experience reviewing scientific information, with sound judgement and attention to detail
Demonstrated understanding of cross-functional relationships across the business (manufacturing, packaging, quality control and assurance as well market demands and supply chain)
Strong Leadership skills (problem-solver), communication and interpersonal skills with high level of professionalism to collaborate with internal partners and to liaise with regulatory authorities (CVM/FDA, EMA)
Proficient in English, both written and oral
Ability to manage multiple projects and products, with high level of organizational skills for prioritization planning, and with flexibility and technical acumen to shift roles on short notice.
Software:
Experience with Veeva Vault is nice to have
Experience with ETQ is nice to have
Senior Scientist
Senior Scientist Job 9 miles from East Orange
81828
**Please ONLY local candidates to Summit NJ with extensive Pharmaceutical and Manufacturing experience. Experience in cell therapy, biologics, or vaccine manufacturing/support
required.
TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.
Our client, a leading pharmaceutical company is hiring a Senior Scientist for a contracting role.
Location: Summit NJ
MUST have Required skills:
Excellent knowledge of evaluating data using statistics and statistical tools, to make data driven decisions
Proficiency in major statistical software packages and programming languages (e.g., R, JMP, MINITAB, or SAS). JMP software preferred.
Summary Report creation/Review in support of CPV (Continuous Process Verification) and APQR (Annual Product Quality Review)
Expert knowledge of cGMP's and multi-national biopharmaceutical/celltherapy regulations
Experience of facility/clean room design, process, equipment, automation,and validation
Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies
Experience with Operational Excellence and Lean Manufacturing
Bachelor's Degree required (science or engineering is preferred); Graduateor higher-level Degree is preferred
8 or more years of work experience in the biopharmaceutical
Experience in CPV and/or APQR reporting preferred
Pay: $51-52/hour W2
Responsibilities:
Focus in CPV (Continued Process Verification) and APQR (Annual Product Quality Review) reporting
Will support the monitoring/trending of production and release testing parameters, in support of product of personalized cell therapy products for both global commercial and clinical trial supply
Will trend CPV parameters, including but not limited to Manufacturing process parameters and Quality Control Release attributes
The purpose of a CPV program is to provide evidence that a process is running under a state of control
The CPV program includes supporting the APQR, as required by regulatory agencies
Travel up to 10% of time may be required within US
Provides support to maintain the site Statistical Process Control (SPC)program, manufacturing performance trending and reporting
Provide multivariate analysis (MVA) modeling for improved process understanding and robustness
Continuously monitor CPV parameters, evaluate Statistical Alert Events
(SAEs), and take needed actions
Scientist / Senior Scientist, Immunology (Treg and CAR T cell therapy)
Senior Scientist Job 16 miles from East Orange
Full-time position
Competitive compensation (Salary, Benefits & Options)
180 Varick Street, New York, and 430 E 29th Street, New York
Waypoint Bio is a venture-backed biotech startup building the next generation of cell therapies for solid tumors and autoimmune diseases. Traditional cell therapy development faces a trade-off between
in vitro
approaches that are fast but inaccurate, and
in vivo
approaches that are accurate but slow and expensive. Using our proprietary platform combining spatial biology, pooled screening,
in silico
protein engineering, and machine learning, we can obtain both depth and breadth when screening cell therapy candidates - speed without compromising on
in vivo
accuracy. Our team is highly collaborative, interdisciplinary, and shares the mission of developing novel immune cell therapies to benefit patients' lives.
Position Summary:
We are seeking a highly motivated, creative scientist who thrives in a fast-paced and collaborative environment. The ideal candidate will have extensive expertise in immunology, including a deep understanding of either regulatory T cells (Tregs) or the design of engineered T cell therapies (e.g. CAR-Treg, CAR-T, TCR-T, or others). Their primary tasks will be to apply their knowledge of the immune system to design novel T cell therapies, optimize the manufacturing of these cell therapies using multiplexed cloning and T isolation & genetic engineering approaches, and then test their function using
in vitro
and
in vivo
models of diseases. In this role, you will work collaboratively with our team of computational and wet-lab scientists to develop cutting-edge technologies and new therapeutic options for patients.
Duties and Responsibilities
Apply your knowledge of immune-related signaling pathways & protein domains to improve the efficacy of existing T cell therapies.
Generate hundreds of innovative designs for cell therapies that address the challenges in different disease indications, with a focus autoimmune diseases and solid tumors.
Work independently to optimize the manufacturing conditions for Treg and CAR T cell therapies, and implement these strategies to generate libraries of T cell therapies.
Develop
in vitro
assays and
in vivo
models of Treg function, and work collaboratively to implement these assays to compare the function of different Treg cell therapy designs.
Implement existing strategies for highly multiplexed cloning, using either pooled cloning or arrayed cloning approaches.
Introduce new technologies and improve the performance, throughput, and accuracy of existing assays
Actively engage in prioritizing key milestones and developing appropriate timelines
Provide conceptual input on experimental design and interpretation in a team setting
Required Qualifications
Ph.D. in Immunology, Cancer Biology, Protein Design, Cell Biology, or a related field. Alternatively, M.S. or B.S. degree with 5 years or 7 years of equivalent experience, respectively.
4+ years of academic or industry experience working on immunology and T cell biology.
Experience culturing T cells
ex vivo
and using these cells for downstream assays.
Strong molecular biology skills for cloning (e.g. Gibson Assembly) and genetic engineering of mammalian cells (e.g. viral approaches, CRISPR systems).
Knowledge of the interplay between the immune system and either healthy tissues or the tumor microenvironment.
Practical knowledge of the immune cell therapy field.
An excellent scientific track record with published papers or recent experience in immunology or cell therapy.
Superb written and oral communication skills, and the organizational abilities to pursue several projects on tight timelines.
Preferred Qualifications
Deep expertise in the design and testing of engineered Treg cell therapies (e.g. CAR-Treg, armored T cell therapies) for autoimmune and inflammatory indications.
Knowledge of the mechanisms used by Treg cells to dampen immune responses in a variety of tissue contexts.
Experience designing novel
in vitro
assays or animal models for autoimmune and inflammatory indications.
Send CV and cover letter to apply:
********************
Research And Development Scientist
Senior Scientist Job 24 miles from East Orange
RESPONSIBILITIES:
Responsible for developing and optimizing fit-for-purpose analytical methodologies across early through late stage product development for injectable and ophthalmic drug products.
Responsible for designing and executing appropriate pre-validation and/or validation studies required to support analytical methodologies.
Must test various samples in support of formulation development, subsequently followed by interpretation of results to provide meaningful guidance to the team.
Must verify co-workers calculations in notebooks/logbooks and verifies results in reports and/or appropriate systems to check for accuracy and integrity of data.
Required to maintain and clean laboratory instruments and equipment.
Required to design and/or execute departmental methods, protocols and SOPs
Must perform other laboratory related miscellaneous duties as required.
QUALIFICATIONS:
A M.S. degree in Analytical Chemistry or related field with 7+ years of experience or a Bachelor's degree with 9+ years of experience
3 - 4 years minimum experience supporting Analytical R&D in regulated industry, familiarity with ICH Guidelines, and world pharmacopeias (USP, EP) are preferred
Equity Research Senior Associate - US Life Insurance
Senior Scientist Job 16 miles from East Orange
Jefferies is seeking a senior associate for its New York-based Life Insurance Equity Research team. The candidate will support the Life Insurance Equity Research team in delivering extensive company and industry research, constructing detailed company and industry financial models, creating written and analytical content for publication and marketing written research recommendations to clients and institutional salespeople.
Responsibilities will include:
Creation and maintenance of earnings and valuation models
Analysis of industry trends and compilation of findings
Production of written research publications
Creation of marketing materials for clients
Development of relationships with management teams and industry contacts
Over time, communication of stock views and industry themes to institutional investors, trading desks, and other internal constituencies within Jefferies
Key qualifications:
Strong work ethic with a focus on teamwork
Fluency in accounting and financial statement analysis
Superior financial statement modeling skills with demonstrated self-auditing abilities
Highly detail-oriented
Strong verbal and written communication skills
Intellectual interest in equity markets
CFA / MBA a plus
Prior equity research or life insurance corporate / industry experience (e.g., FP&A, Corporate Treasury, business unit finance) preferred
Primary Location Full Time Salary Range of $135,000 - $165,000.
R&D Scientist
Senior Scientist Job 12 miles from East Orange
Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment.
About the role
We are seeking a talented and dedicated Scientist to join our team. The successful candidate will be responsible for developing and preparing beverage formulations, syrups, or beverage concentrates at lab and pilot plant scale, following direct customer specifications.
Key responsibilities
Develop and prepare beverage formulations, syrups, or beverage concentrates at lab and pilot plant scale.
Test and establish beverage formulations according to specific taste profiles and regulatory requirements.
Customize beverage ingredients independently or within a cross-functional team environment.
Calculate calories and understand sweeteners and nutrients in formulations.
Facilitate the shipment of samples for internal and external customers.
Support beverage and taste development under proper GMPs and safety standards.
Maintain flexibility to meet deadlines and handle multiple tasks with speed and high accuracy.
Master beverage formulation for sparkling, still, juice and functional beverages.
Exceptional sensory skills to define and discriminate flavor profiles in short timelines. Ability to work on RTD and RTM formats at different concentration levels.
Deep understanding of beverage processing techniques and nutritional value calculations.
Good communication skills to explain formulations at a commercial setting with customers.
Good mathematical skills to work with dilutions, percentages and ppm on ingredients.
Self- motivated to find a solution to complex problems.
Qualifications and skills
Degree on Food Technology, Biology, Chemistry, or a related Applied Science.
Scientific and analytical aptitudes.
Basic computer and mathematical skills.
Prior CPG or flavor application experience is preferred.
The typical hiring range for this role is $73,758 to $108,755 annually and is based on several factors including but not limited to education, work experience, certifications, location, etc. In addition to your pay, Kerry offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and retirement contribution (all benefits and incentives are subject to eligibility requirements.
Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov).
Beware of scams online or from individuals claiming to represent us. A Kerry employee will not solicit candidates through a non-Kerry email address or phone number. In addition, Kerry does not currently utilise video chat rooms (e.g., Google Hangouts) to conduct interviews. Refuse any request that asks you to provide payment to participate in the hiring process (e.g., purchasing a “starter kit,” investing in training, or something similar). Kerry will not ask you to pay any money at any point in the hiring process with the exception of reimbursable travel expenses. In addition, any payments made by Kerry will be from official firm accounts bearing the Kerry name.
Manufacturing Scientist
Senior Scientist Job 20 miles from East Orange
Opportunity for an experienced Upstream Manufacturing Scientist (multiple levels) to continue their career in downstream/upstream manufacturing. This role will be with our client who has a global footprint in both R&D and manufacturing within the biopharma industry.
Location- Middlesex County, NJ
Terms: Direct Hire
Salary: $80-100k/yr.
What you will be doing:
Work closely with manufacturing associates and engineers to execute upstream batch processes.
Perform cell culture and bioreactor operations (single-use fed-batch bioreactors) across various scales.
Carry out harvest clarification processes using centrifuges and depth filters at multiple scales.
Ensure timely execution of engineering and clinical batches.
Develop equipment specifications and optimize manufacturing techniques.
Leverage programs to collect and analyze operational data, making real-time adjustments to products, instruments, and equipment.
Interpret and follow instructions in written, oral, diagrammatic, or scheduled formats.
Adhere to GMP standards in the manufacturing area and lead compliance with environmental health and safety regulations.
Review completed manufacturing and packaging batch records and supporting documentation.
Coordinate investigations and implement corrective actions for any issues identified during batch execution.
Perform additional duties as assigned.
Comply with all company policies and standards.
What you bring to the company:
Bachelor's or Master's degree in Chemical, Biological, or Biochemical Sciences, with at least 3 years of relevant experience in the biopharmaceutical industry.
Proven expertise in independently designing, executing, analyzing, and documenting all phases of process development.
Strong foundational knowledge and subject matter expertise in executing both engineering and clinical batches.
Hands-on experience in GMP and aseptic manufacturing environments.
Familiarity with single-use manufacturing consumables, such as bags, tube sets, columns, and process manifolds. Proven ability to work both independently and collaboratively within a team; excellent interpersonal skills.
Strong verbal and written communication skills, with advanced computer and organizational abilities.
High attention to detail and proficiency in basic software, including Word, Excel, and spreadsheets.
In-depth understanding of GMP batch manufacturing and packaging documentation, including audit and review procedures.
Knowledge of cleaning verification and validation processes.
**
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**
Flowcytometry scientist
Senior Scientist Job 19 miles from East Orange
Bio Analytical scientist
Duration: 12+ Months (Extendable)
is Onsite
Pay Rate: $38.00/hr on W2(Without Benefits included in the pay you will have you buy them separately by paying price for the benefits)
Client: Pharmaceutical
Bio-Analytical Scientist
Warren, NJ- Onsite
Work Schedule: Mon - Fri, Business Hours
Summary:
Executes experiments and analyzes data from flow cytometry analytical assays with limited supervision, as part of the Cell Therapy Analytical Development (CTAD) team. Executes experiments to support on-going method development to support drug product release. Responsible for ensuring compliance with good laboratory practices and other regulatory guidelines. Interfaces with internal research groups and clinical groups and assures laboratory productivity and technical research flexibility. Helps to oversee laboratory needs to ensure appropriate inventory/maintenance.
Responsibilities
• With limited supervision and/or oversight; design and execute analytical experiments of moderate complexity.
• Perform data analysis, summarize and report experimental results. Present data in group meetings and work
collaboratively to determine next steps.
• Document/review laboratory work in e-notebooks that is detailed, accurate, timely, and in compliance with Good
Documentation Practices.
• Ensure proper operation and perform routine maintenance of laboratory equipment as needed.
• Potentially could be working with biological material--no exposure to animals.
Skills/Knowledge
• Required B.S. with 2 - 4 years work experience or M.S. with 0 -2 years experience in Molecular & Cellular Biology,
Immunology, or related discipline.
• Experience working in a regulated (GLP/GMP) environment in preferred.
• Flow cytometry assay development experience is preferred.
• Experience with flow cytometry platforms is preferred: Miltenyi Macsquant, BD Symphony A5 and/or Canto,
Beckman Coulter Cytoflex
• Experience with flow cytometry software is preferred: Flowjo, FCS Express
• Assay qualification/validation experience is preferred.
• Excellent organization skills and ability to handle multiple tasks
• Highly motivated, willingness to acquire new skills, and ability to work with minimal supervision.
• Excellent verbal and written communication skills.
• Must be proficient in microsoft suite
Senior Quantitative Equity Researcher
Senior Scientist Job 10 miles from East Orange
Jacobs Levy is seeking a Senior Quantitative Equity Researcher for our Florham Park, NJ office with a strong background in technical computing and statistics to join our research team. The team is responsible for researching all aspects of the investment process from data processing and alpha modeling through to portfolio optimization. Our researchers work collaboratively to contribute to our firm's leading edge, innovative investment process. We seek people who are passionate about equity investment and motivated to outperform the market
.
Responsibilities include:
Conducting exploratory data analysis
Empirical research into U.S. and global equity market inefficiencies
Reviewing financial literature
Developing new and improving existing investment models by identifying novel investment ideas and innovative data sources
Creating innovative investment strategies
Ideal candidates will look to combine creative insights with research to make sound investment decisions.
Requirements include:
PhD in Finance, Econometrics, or related quantitative discipline
Familiarity with fundamental, expectational and market data
Solid knowledge of asset pricing literature
Strong programming skills (C++, C#, Fortran, Java, Julia, Python etc.), preferably experienced with large datasets and also familiar with parallel programming
Version control experience (such as Git)
An understanding of Bayesian Statistics, Machine Learning, Non-Linear Estimation Methods, Optimization, Transaction Cost Modeling, or Data Visualization is a plus
At least 3 years of empirical equity research experience
Independent thinker with good economic intuition and demonstrated record of original research
Ability to work collaboratively across departments and to explain challenging technical concepts
Associate Production Scientist
Senior Scientist Job 20 miles from East Orange
About GenScript
GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.
GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.
About ProBio
ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, ProBio has a stable and high-yield viral vector platform.
Position: Associate Production Scientist
Location: Piscataway, New Jersey
Report to: Production Manager, Integrated DNA Chip
Role Description:
We are looking for a dedicated and hardworking associate scientist to join a cross-disciplinary team to help us develop and support advanced oligonucleotide synthesis technologies and applications. The candidate will play a key role in our production team providing support to both routine and investigatory laboratory activities. Knowledge of oligonucleotide synthesis chemistry, hybridization assays, PCR and qPCR techniques, and next-generation sequencing are desirable, but training will be provided as well. Position will also include primary responsibility over maintaining critical inventory by monitoring usage rates and actively producing inventory using proprietary technology and methodology. Level of the position will be commensurate with the qualifications of the final candidate.
Key Responsibilities:
Perform array-based oligonucleotide synthesis on GenScript's CMOS semi-conductor synthesis platform.
Perform QC operations on GenScript products including PCR and hybridization assays.
Perform additional pre and post synthesis operations associated with the production of GenScript products.
Follow and update key SOP documents as needed. Maintain production records.
Conduct routine lab maintenance procedures.
Contribute observations and experience to production team to optimize and improve processes.
Manage critical inventory levels and proactively schedule and conduct production of critical materials
Produce and maintain manufacturing records according to ISO9001 regulations and as per QMS
Provide additional support as we expand the scope of our technology.
Qualifications:
Bachelor's degree in Biology or Chemistry related field with 2 years of hands-on experience. Master's degree a plus.
Working knowledge of oligonucleotide synthesis
Experience with surface chemistry techniques and electrochemistry desirable
Good grasp of basic molecular biology techniques including PCR, qPCR, array-based hybridization assays, and NGS.
Familiarity with vacuum instrumentation and surface coating/modification techniques highly desirable
Ability to work as part of a small cross-disciplinary team to accomplish both short term and long term goals.
#LI-EB1
#GS
GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.
Production Scientist
Senior Scientist Job 19 miles from East Orange
We are seeking a Production Scientist for our Manufacturing Department in Warren. The Production Scientist will provide day-to-day operations support in a cGMP manufacturing environment for the production of BeadChip and NGS products including formulation of bead intermediates, bulk reagents,and filled vials. If you are interested in helping to save patient lives, this may be the role for you!
This position is
not eligible for sponsorship for work authorization
. Therefore, if you will requires sponsorship from us for work authorization now or in the future,
we cannot consider your application at this time
.
Responsibilities
Key Accountabilities:
Perform the following activities in a quality focused cGMP manufacturing environment:
BeadChip carrier assembly - involves manual and automated equipment processes.
Formulate custom bulk reagents - involves working with pipettes and balances.
Bulk and fill reagent manufacturing.
Weighing, diluting, measuring and verifying chemicals for in-process solutions.
Packaging of carrier and reagent boxes.
Ensure materials and equipment are available in inventory for production as required.
Follow manufacturing schedule. Report issues and concerns to management.
Perform equipment setup, operation, re-supply, documentation, cleaning, minor equipment adjustments and minor preventative maintenance tasks to meet standards for safety, quality and efficiency.
Follow GMP documents (e.g., SOPs, Work Instructions, Manufacturing Records) with strict adherence to safety and compliance.
Create legible written records within batch records/forms.
Write, revise and update manufacturing documentation.
Maintain a clean and organized working lab environment.
Responsible for training on all procedures assigned. Ensure all training is up to date and appropriately documented.
The ability to be cross trained to assist in other production areas /departments as needed.
Follows OSHA safety regulations for bloodborne pathogens.
Qualifications
Minimum Knowledge & Experience required for the position:
Bachelors Degree in a science related field.
Preferred cGMP manufacturing experience and/or training.
Basic knowledge of MS Office and software systems used in product support.
May be required to work irregular hours and days necessary to meet production schedules.
Overtime may be required which may include holidays and weekends.
Biology Expertise Sought for AI Fact Checking
Senior Scientist Job 8 miles from East Orange
Outlier helps the world's most innovative companies improve their AI models by providing human feedback. Are you an experienced Biology who would like to lend your expertise to train AI models? About the opportunity: Outlier is looking for talented accounting and tax experts to help train generative artificial intelligence models This freelance opportunity is remote and hours are flexible, so you can work whenever is best for you You may contribute your expertise by…Assessing the factuality and relevance of domain-specific text produced by AI models Crafting and answering questions related to BiologyEvaluating and ranking domain-specific responses generated by AI models Examples of desirable expertise:A bachelor's or higher degree in Biology or a related subject Experience working as an Biology professional Ability to write clearly about concepts related to Biology in fluent EnglishPayment:Currently, pay rates for core project work by Biology experts range from $30 to $50 per hour USD.
Rates vary based on expertise, skills assessment, location, project need, and other factors.
For example, higher rates may be offered to PhDs.
For non-core work, such as during initial project onboarding or project overtime phases, lower rates may apply.
Certain projects offer incentive payments.
Please review the payment terms for each project.