Associate Scientist MSAT Advanced Therapies Validations
Scientist job in Raritan, NJ
The Associate Scientist MSAT Advanced Therapies Validation is responsible for validating supporting processes, implementing improvements within commercial manufacturing, and managing the lifecycle of these processes. The Associate Scientist acts as a Subject Matter Expert for validation studies, particularly in optimizing commercial manufacturing of lentiviral vectors, and liaises with various stakeholder departments.
Responsibilities:
Contribute to Life Cycle Management (LCM) and New Technology Introduction for the site.
Execute validation of supporting processes (e.g.,mixing, sterilization, thermal processing, bio-decontamination).
Support the introduction of new technologies and digitalization projects through validation protocol execution.
Support the introduction of new materials via execution of validation protocols.
Validate process parameters (e.g., process hold times).
Contribute to Life Cycle Management projects.
Act as Subject Matter Expert for one or more validation categories. Leverage the global MSAT network to identify and implement best practices.
Author and review well-documented protocols and reports for all processes to be qualified/validated, in accordance with corporate/site guidelines, procedures, regulatory requirements, and industry best practices.
Coordinate and support the execution of validation studies that conform to site standards and client guidelines, while meeting quality requirements.
Support the site change control program by performing validation impact assessments and delivering the resulting implementation plan.
Investigate deviations associated with process validation activities and oversee pre-validation and validation activities resulting from technical changes.
Propose and formalize enhancements to qualification and validation processes and procedures to support process validation throughout the lifecycle and ensure program sustainability.
Assist with writing Quality Risk Assessments for existing and new or changed processes.
Ensure integration of global standards into local production processes.
Support complex investigations and risk assessments.
Act as SME during internal and external audits and inspections.
Experience:
Minimum of 2 years of relevant Manufacturing, Science, & Technology experience in the pharmaceutical industry.
Experience with cell therapy manufacturing or viral vector manufacturing.
GMP manufacturing and/or validation experience in pharmaceuticals.
Skills in communication, planning, documentation, risk management, root cause problem-solving, and knowledge management.
Understanding of regulatory requirements and industry guidelines for validation (e.g., FDA, EMA, ICH, ASTM, ISO, ISPE, PDA, etc.).
Affinity with process technology and digitalization in manufacturing.
Capable of successful delivery of local small projects, regional project work streams, or departmental programs under supervision. Selects applicable engineering/scientific tactics.
Works independently within scope, requiring general guidance.
Skills:
Stem Cell Therapy
Good Manufacturing Practices (GMP)
Drug Manufacturing
Education:
BSc in Biochemistry, Biotechnology, Chemical Engineering, or a related field.
Advanced degree (MSc/PhD) in Biochemistry, Biotechnology, Chemical Engineering.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter Details:
Name: Azhar
Email: ****************************
Internal Id: 25-53773
Bioanalytical Senior Scientist
Scientist job in Rahway, NJ
Title: Bioanalytical Senior Scientist
Duration: 12+ months(Extendable)
Pay Range: $45 -$53 per hour on W2.
NOTES: Must be able to travel between Rahway, NJ site and West Point, PA site as needed. Travel up to 50% may be required.
Qualifications:
Minimum Educational Requirement:
• Ph.D. degree in chemistry, biochemistry or related scientific discipline with 3 years of industrial experience, or Master of Science degree in chemistry, biochemistry or related scientific discipline with at least 7 years of industrial experience, preferably in a bioanalytical laboratory.
Required Experience and Skills:
• Experience in developing, validating and implementing ligand binding assays under GLP.
• Possess excellent written and verbal communication skills.
• Experience in Watson or other LIMS systems.
• Proficiency with Microsoft Office products.
Preferred Experience and Skills:
• Highly motivated individual with the aspiration to learn and develop himself/herself.
• Experience in LC-MS/MS assay.
Responsibilities:
Seeking a motivated individual to work as a senior bioanalytical bench scientist within its Good Laboratory Practices (GLP) bioanalytical laboratory. This is a bioanalytical senior scientist position with primary duties in performing laboratory work, preparing reports, and interacting with internal and external partners.
This position is a part of the Bioanalytical group, Global Preclinical Development, based in Rahway, New Jersey. Main responsibilities include:
• Independently developing, optimizing and troubleshooting LBA methods to support projects with method quality and efficiency in mind; writing bioanalytical methods; assumption of project responsibility in delegated bioanalytical aspects.
• Proficiently and independently implementing ligand binding assays (LBA) for the analysis of biological samples in a GLP environment, with duties inclusive of, but not limited to, sample preparation, setting up instruments, processing, and interpreting data; solving issues encountered during method implementation independently.
• Establishing LBA capability within the team including equipment purchasing, setting up lab and LBA workflow.
• Ensuring that all documentations are in real time, accurate and compliant with current GLP and departmental guidelines.
• Preparing reports (sample analysis and validation) independently; Assembling all documents for regulatory submissions; Compliance with and maintenance of required training for company and departmental SOPs, safety-related guidance and other guidelines as relevant/applicable.
• Adherence to short term goals, objectives and timelines agreed upon with management, via working independently (e.g., with little to no management oversite in this regard).
• Interaction with partners in other functional lines, such as Drug Safety and Metabolism, Quality Assurance, and program management.
• Any relevant/applicable additional BA assignments as directed by management.
• Ability to multi-task and be a team player.
Clinical Scientist Data Reviewer
Scientist job in Jersey City, NJ
6 month contract w/ renewal
3 days onsite in Jersey City, NJ
We are seeking a Clinical Scientist Data Reviewer that will support the scientific planning efforts and collaborate with Clinical Research, Pharmacovigilance and Clinical Operations in the execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate technical skills and scientific acumen as part of a cross-functional clinical development team. You will be a key contributor and supporter in the clinical science activities of evidence generation for regulatory approval and/or engagement with physicians, including protocol development, study implementation, data analysis and reporting of results. This role will be focused on the detailed and critical safety data review efforts from study start-up through final CSR. The Clinical Scientist Data Reviewer is a crucial role in analyzing and interpreting clinical trial data to ensure accuracy, integrity, and compliance with regulatory requirements. There is additional room for growth and leadership opportunities in this role.
Responsible for supporting specific aspects of clinical/scientific execution of clinical protocol(s). This may include:
Serving as a supportive clinical scientist data reviewer focused on safety, efficacy and critical data deliveries as part of the clinical trial team
Supporting the clinical study team as part of the clinical sciences functional line which is closely aligned with the medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with Clinical Research and Pharmacovigilance (as well as other functional areas in this matrix environment)
Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); partnering with Clinical Operations on critical and key study deliverables
Ensure CRF design supports data collection in alignment with the Protocol in collaboration with Clinical Data Management/Programming
Collaborating cross-functionally to review clinical data to ensure quality, completeness, and integrity of trial conduct
Potential to provide tactical/scientific mentorship to other clinical scientists and move into Clinical Scientist lead role as well as focus on scientific growth and development
Responsible for assisting with the generation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations (including authoring documents and slide preparation as appropriate)
Apply proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; identifies risks and designs mitigation strategies
Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs
Qualifications
6+ years of experience with a Post Graduate Degree or 8+ years of experience with a Bachelor's degree in a relevant scientific discipline.
Experience in clinical drug development experience, or a PhD, Pharm D, or RN degree is preferred.
Experience within oncology preferred
Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
Ability to manage multiple competing priorities with good planning, time management and prioritization skills
Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions
Proficient scientific expertise to propose, design, and execute clinical research and development studies, and authors documents related to clinical trials, such as medical monitoring plan, SAPs, informed consent and clinical components of the Clinical Study Reports
Interact with key stakeholders across Clinical Development functional areas
Role requires proactive approach, strategic thinking and leadership in driving toward clinical study goals
Influence opinions and decisions of internal and external customers / vendors, across functional areas
Problem solving, prioritization, conflict resolution and critical thinking skills
Strong communication, technical writing, and presentation skills experience
Applied Data Scientists
Scientist job in Sayreville, NJ
**1\. Role Overview**Mercor is seeking applied data science professionals to support a strategic analytics initiative with a global enterprise. This contract-based opportunity focuses on extracting insights, building statistical models, and informing business decisions through advanced data science techniques. Freelancers will translate complex datasets into actionable outcomes using tools like Python, SQL, and visualization platforms. This short-term engagement emphasizes experimentation, modeling, and stakeholder communication - distinct from production ML engineering. **2\. Key Responsibilities**
● Translate business questions into data science problems and analytical workflows
● Conduct data wrangling, exploratory analysis, and hypothesis testing
● Develop statistical models and predictive tools for decision support
● Create compelling data visualizations and dashboards for business users
● Present findings and recommendations to non-technical stakeholders **3\. Ideal Qualifications**
● 5+ years of applied data science or analytics experience in business settings
● Proficiency in Python or R (pandas, NumPy, Jupyter) and strong SQL skills
● Experience with data visualization tools (e.g., Tableau, Power BI)
● Solid understanding of statistical modeling, experimentation, and A/B testing
● Strong communication skills for translating technical work into strategic insights **4\. More About the Opportunity**
● Remote
● **Expected commitment: min 30 hours/week
● Project duration: ~6 weeks** **5\. Compensation & Contract Terms**
● $75-100/hour
● Paid weekly via Stripe Connect
● You'll be classified as an independent contractor **6\. Application Process**
● Submit your resume followed by domain expertise interview and short form **7.About Mercor**
● Mercor is a talent marketplace that connects top experts with leading AI labs and research organizations
● Our investors include Benchmark, General Catalyst, Adam D'Angelo, Larry Summers, and Jack Dorsey
● Thousands of professionals across domains like law, creatives, engineering, and research have joined Mercor to work on frontier projects shaping the next era of AI
Research Scientist
Scientist job in Piscataway, NJ
Onsite in 909 River Road Piscataway, NJ 08854
Monday - Friday, 8am - 4pm (with some flexibility)
Reason for request: Lab development, stability, data integration/analysis work
JOB DESCRIPTION:
Perform appropriate Lab practices and procedures for making product formulation and testing of products. Follow product stability protocols. Maintain, monitor, validate and calibrate lab equipment, as necessary. Prepare reports, collect data analysis, and communicate progress and completion of tests to leadership. Maintain good record keeping habits.
Responsibilities include:
Lead the development and implementation of new toothpaste formulas for North America - under the hello and Tom's of Maine brands.
Be the R&D point of contact for commercial teams for hello and Tom's key innovation.
Lead experimental designs to help identity launch formulations and production processes.
Make lab and pilot batches of formulations for stability testing and customer sampling.
Support Pilot Plant batches by preparing batch sheets, requesting raw materials, pre-weighing materials and batch execution.
Support plant trial batches at various North America locations as needed.
Manage multiple stability studies at the lab, pilot and plant scale, working with support groups (analytical, flavor, micro, etc) to deliver samples and follow up on results.
Create/maintain all required R&D documentation to ensure flawless, high quality commercialization.
This may include R&D project timelines, formula databases, tech transfer checklists, proof of claims documents, registration documents, NODs, change control documents and technical justifications.
Manage independent projects and collaborate with cross-functional teams, leveraging diverse perspectives to achieve key project goals and influence beyond your network
Create and maintain all required documentation under GMP/GLP per FDA/ICH guidelines as required.
Validate new raw material suppliers and packaging as required.
Maintain a clean and organized working environment.
Work on multiple tasks with changing priorities.
Make day-to-day recommendations and escalate issues regarding formula development.
Stay abreast of supplier and competitor's new developments.
Abide by and follow all company standard operating procedures (SOPs) including those for product development, regulatory and safety.
Deliver effective presentations of technical data and project status.
Required Qualifications
Bachelor's or MS Degree in Chemistry, Chemical Engineering, Biochemistry, Food Science or related fields.
4+ years of experience developing and/or implementing consumer products.
Experience scaling up formulations from the lab through pilot or manufacturing scale.
Technical understanding of related chemistry and science (for example: active deliveries, emulsions, surfactants, rheology, liquid chemistry)
Strong knowledge of ingredient chemistry to be able to understand how the interdependencies and interactions of raw material components affect formulation and process performance
Able to multi-task and coordinate various simultaneous projects
Strong oral and written communication skills
Self-motivated but able to work well within a team environment
Knowledge of cGMP /GMP and GLP
Excellent computer skills (MS Office, Google suite, SAP, etc.)
Preferred Qualifications
Knowledge of equipment and procedures for making oral care formulations
Experience running stability studies for OTC/Drug products
Experience & understanding of producing formulations at the manufacturing scale.
Experience with claim substantiation.
Strong project planning and management experience
Knowledge of Regulatory environment in North America and across the globe
Knowledge of ICH/FDA guidelines for stability and testing of new drug products
Other Required Experience/Qualifications:
Previous laboratory experience preferred.
Must have hands-on experience with laboratory instruments.
Must be able to learn new procedures in a short period of time.
Must be able to follow SOPs and obtain reliable and accurate data.
Must be able to document data consistently and accurately.
Must be able to perform routine tasks daily
RD&A Process Scientist - Food Industry
Scientist job in Clark, NJ
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
The RDA Process Scientist performs research and development work with an operations focus which bridges the gap between RD&A Taste Innovation and KERRY's commercialization process. He/she will focus on process optimizations, scale-ups, solving regulatory and other hurdles to new products and technologies introductions. He/she will collaborate with other scientists (especially Taste Innovation team), engineers, maintenance, QC, sanitation, etc.
Key responsibilities
Work closely with Taste Innovation team to develop and scale up taste modulation products
Focus on solving the regulatory hurdles
Liaising with cross functional teams: engineering, research, technical, QC, sanitation, maintenance, and/or production staff, regulatory, procurement, etc.
Planning, organizing, and overseeing process or production trials
Suggests improvements or modifications to current processes
Generates ideas for new products and researches feasibility in terms of profitability, resource availability and compliance with regulations.
Adheres to Standard Operating Procedures (SOPs) and Cleaning In Place (CIP)
Keeps recording data log (flow rate, pressure, temperature, etc) and analyzing data
Writes and reads technical papers, reports, reviews, and specifications.
Qualifications and skills
Bachelor's or Master's in food process science, food engineering, agricultural science, engineering, material science or related science fields.
Experience in a food production environment or industrial laboratory Experience with upscaling of food manufacturing processes is a plus: moving from lab scale to industrial scale.
Knowledge of good manufacturing practice
Problem-solving skills, analytical skills, and attention to detail
Strong communication and interpersonal skills, able to work effectively as part of a team.
Excellent analytical, organizational, and multi-tasking skills.
The pay range for this position is $107,757 to $181,563 in Annual Salary. Kerry typically does not hire an individual at the top or near the top of the range, as we are a pay-for-performance company, and this range is set to continue to reward performance annually while in role. Compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate within the above range may be influenced by a variety of factors including skills, qualifications, experience, and internal equity. Kerry offers a competitive benefits package, including medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, Employee Share Plan, Life, disability, and accident insurance, and tuition reimbursement. This job posting is anticipated to expire on Jan 30th, 2026.
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.
Analytical Scientist
Scientist job in Somerset, NJ
Job Title: Analytical Scientist - Solid Oral Product Development
The Analytical Development Department is dedicated to the successful and timely development of new pharmaceutical solid oral products by providing essential analytical development services to clients. The Analytical Scientist will offer analytical support for the team, contributing to the evaluation, development, and validation of analytical methods with limited supervision. The role also involves conducting routine analyses of active pharmaceutical ingredients (APIs) and finished products using advanced laboratory techniques and instrumentation.
Specific Duties, Activities, and Responsibilities
Perform hands-on method development, improvement, and validation using techniques including, but not limited to: HPLC, GC, Dissolution, UV-Vis Spectroscopy, FTIR, Microscopy, and Particle Size Distribution (PSD).
Assist in complex analytical experiments such as unknown impurity identification and excipient compatibility studies.
Effectively prioritize activities to provide timely analytical support to product development initiatives.
Anticipate analytical challenges in the R&D development process and provide strategic long-term planning for method development and enhancement.
Support formulation development and technology transfer activities for assigned projects.
Investigate method performance and reliability, and conduct optimization studies as necessary.
Collaborate in the preparation of technical documents, including validation protocols and reports, stability protocols and reports, and analytical test procedures.
Education and Experience
Bachelor's degree (BS) in Chemistry, Biochemistry, or a related discipline with 6-8 years of pharmaceutical industry experience, or
Master's degree (MS) in Chemistry, Biochemistry, or a related discipline with 4+ years of pharmaceutical industry experience.
Knowledge/Skills
Solid working knowledge of GxP principles, regulatory (ICH) guidelines, and compendial (USP/EP/JP) requirements for generic product development.
Analytical Chemist
Scientist job in Dayton, NJ
Kelly is hiring a QC Analytical Chemist for a 6 -month Contract role with one of our prestigious clients based out in Dayton, NJ 08810.
Job Title: QC Analytical Chemist
Employment Type: 6-month contract
Pay rate: $25-32/hr.
Shift: 8 am - 4:30 pm
It's an exciting time to be part of Quality Control team. In this position, you will assist with ensuring finished and raw materials are consistent with specifications through analytical testing. As part of the Quality Control department, you will perform wet chemistry analyses based on standard operating procedures as well as sample preparation, data acquisition, data interpretation, and reporting in support of production.
You will spend your time…
Calibrating and working with analytical equipment daily, including but not limited to: density meter, refractometer, pH meter, titratable acidity, spectrophotometer, moisture analyzer, KF titrator, chlorides titrator
Performing tests on finished and raw materials and reporting results
Preparing samples, acquiring data, interpreting results
Critically thinking and assisting with the investigation of internal and external non-conformances
Other duties as assigned
Required Skills:
Bachelor of Science Degree in Chemistry or Science related field
Strong communication skills both written and verbal
Knowledge of basic math and science
Basic knowledge of computers and Microsoft Office
Ability to multitask within the lab to efficiently maintain lab workflow
If you believe you are a good fit for this opportunity, please submit your application through the job posting link. We also encourage you to share references if you have them.
Analytical Chemist I/II/III
Scientist job in West Caldwell, NJ
Analytical Chemist will be engaged in the different laboratory testing using a range of analytical equipment and techniques within GMP laboratory.
MAJOR DUTIES/RESPONSIBILITIES:
Perform assigned testing including but not limited to the physical, chemical tests per in-house written procedures and compendial monograph for the raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemistry, physical and instrumental techniques such as LC, GC, UV-Vis Spectrophotometer, dissolution, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments.
Document work clearly and perform tests accurately. Record data and results as specified in documentation procedures.
Maintain proper laboratory logbooks, notebooks and other records all the time. Report and participate in the deviations and investigations.
Comply with all regulatory/in-house requirements (may include but not limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.
· Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by Standard Operating Procedures (SOPs).
· Perform laboratory related other duties as assigned.
MINIMUM/PREFERRED REQUIREMENTS:
Education: Bachelor's Degree in Science/Chemistry
Experience: Based on the position level, must require minimum 2-10 years prior experience working in the Quality Control Laboratory in a cGMP environment, preferably in pharmaceutical industry.
Hands on Empower-3 experience is plus.
QC experience in Generic Pharmaceutical industries would be preferable
Knowledge in Good Documentation practices. Knowledge in USP/ FDA
BENEFITS: Offers a comprehensive benefits package to employees
Downstream Manufacturing Scientist
Scientist job in Piscataway, NJ
The Downstream Manufacturing Scientist is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars. The candidate will be responsible in the purification of 50L to 1000L volumes engineering, clinical and commercial batches in a cGMP environment. This position requires technical expertise in AKTA purification skids or similar, TFF and knowledge of initiating batch records, protocols, investigations and other technical documents.
Work in a team environment to execute batches and can work independently with minimum supervision. This position requires extensive technical expertise in mammalian cell-based purification processes, cGMP manufacturing and compliance for BLA requirements.
Essential Duties & Responsibilities
Perform downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
Provides technical direction in the execution and development of the purification process.
Uses programs to collect and evaluate operating data to conduct on- line adjustments to products, instruments or equipment.
Ensure that engineering and clinical batches are executed in a timely manner.
Establishes operating equipment specifications and improves manufacturing techniques.
Works with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment.
Should follow GMP instructions in the manufacturing area and take the lead to follow environmental health and safety policies.
Coordinate the conduction of investigations and corrections for issues found during the batch execution process.
Performs other functions as required or assigned
Complies with all company policies and standards
Requirements
Education:
Requires a Bachelor or Master' degree in chemical, biological or biochemical sciences and a minimum of 4- 5 years of related experience in the biopharmaceutical industry.
Previous experience working in GMP and aseptic manufacturing environment.
Experience working with AKTA Process skids or similar and familiarity of single use manufacturing consumables such as bags, tube sets, columns and process manifolds.
Possess knowledge to execute engineering and clinical batches; familiar with GMP documentation.
Special Skills:
Ability to work with other team members and independently - good interpersonal skills.
Good communication skills: verbal and written, good computer and organization skills, detail oriented.
Basic computer skills, including knowledge of Word, Excel and spread sheet
Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
Knowledgeable in cleaning verification/validation.
Work Environment & Physical Demands:
General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may be involved.
Supervisory Responsibility, if any: No
This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.
Product Development Scientist
Scientist job in Summit, NJ
Kenvue is currently recruiting for a:
Product Development Scientist
What we do
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA , AVEENO , TYLENOL , LISTERINE , JOHNSON'S and BAND-AID that you already know and love. Science is our passion; care is our talent.
Who We Are
Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. For more information, click here.
Role reports to:
DIRECTOR 1
Location:
North America, United States, New Jersey, Summit
Work Location:
Fully Onsite
What you will do
The Product Development Scientist will be responsible for formulating new baby products in line with brand strategies, conducting Design of Experiments and stability analyses, and providing technical support throughout the product lifecycle. Key duties include identifying and addressing project challenges, analyzing market trends for product differentiation, defining process parameters in collaboration with manufacturing, and participating in cross-functional teams for product execution. The role also involves planning and prioritizing multiple projects, maintaining organized documentation, drafting technical reports, and ensuring compliance with quality and regulatory standards.
Key Responsibilities:
· Formulate new products that align with the Baby brand strategy and pipeline with supervisor oversight.
· Conduct Design of Experiments, laboratory activities and analysis with hands-on involvement.
· Provide technical support for product lifecycle management, including post-commercialization support and troubleshooting technical issues.
· Proactively identify project obstacles and technical risks, evaluating potential solutions to minimize impact through data-driven decision-making.
· Analyze and translate key trends into insights, understanding the competitive landscape to enhance product uniqueness and differentiation.
· Define critical process parameters and collaborate with manufacturing sites to establish process controls.
· Participate in cross-functional regional and/or global project teams to execute new products.
· Plan and prioritize multiple projects and tasks to meet deliverables, monitor ongoing activities and updating stakeholders.
· Maintain accurate and organized records of project documents, data, and materials.
· Manage routine organizational processes and complexity.
· Draft and complete technical documents, including peer-reviewed manuscripts, development summary reports, specifications, and patent filings.
· Adhere to established standards and processes (e.g., GDP, GLP) to ensure compliance with quality, safety, and regulatory requirements.
Qualifications:
What we are looking for
Required:
· Bachelor's degree in Science, Engineering, Pharmacy with pharmaceutical or consumer (cosmetics, OTC) experience
· Minimum of 3 years of related experience or a Master's degree with 1-2 years of related experience
· Ability to work cross-functionally in a team environment while being an individual contributor
· Ability to handle routine processes and complexity, risk taking and decision making
· Detail-oriented, organized, and able to manage multiple tasks
· Technical writing skills that facilitate the creation of documents that are complete & accurate
· Proficient oral and written communication skills
· Effective presentations skills that are used to communicate clearly & informatively
· MS Office (Word, Excel, PowerPoint) proficiency
Desired:
· Degree in Chemistry, Chemical Engineering, Industrial Pharmacy
· Experience with consumer products, such as skin care, emulsions, cleansers, hair care, oral care, baby care and/or deodorant products
· Good technical foundation of formulated products including emulsions, surfactants, suspensions, structured liquids and an understanding of material chemistry
· Experience collaborating with external partners (manufacturing vendors), suppliers, and technical project management
· Familiarity with cGMP and other regulatory requirements
What's in it for you
Annual base salary for new hires in this position ranges:
$81,175.00 - $114,600.00
This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.
Competitive Benefit Package*
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Kenvuer Impact Networks
This list could vary based on location/region
*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
Auto-ApplyAssociate Research Scientist: LBA PK & ADA Method Development & Validation
Scientist job in Lawrenceville, NJ
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
Summary:
The primary purpose of this position is to contribute to developing, validating, and implementing bioanalytical immunoassays for the measurement of pharmacokinetics (PK), anti-drug antibodies (ADA), and neutralizing antibodies (NAb) in biological samples to support drug development and regulatory filing.
Essential Functions:
• Develops, validates, and implements immunoassays for the analysis of clinical and non-clinical pharmacokinetic or toxicokinetic samples in a GLP-like or GLP environment with some level of guidance
• Ensure assay performance meets regulatory expectations for specificity, sensitivity, precision, accuracy, and robustness.
• Independently troubleshoot and optimize ligand binding PK and ADA assays to ensure robustness and reproducibility.
• Maintain lab inventories and order lab supplies to ensure continuity of bioanalytical activities.
• Utilize Watson LIMS and Electronic Lab Notebooks (ELN) for data processing, documentation, and reporting.
• Ensures that electronic notebooks and other documentations are up to date as per departmental guidelines
• Prepare or contributes to study reports following the departmental policies and procedures.
• Ensures compliance with and maintains required training in BMS and departmental GLP, SOP, safety and other departmental guidelines
• Achieves objectives in a manner consistent with the Core BMS Behaviors
• Prepares and makes scientific presentations at internal and external meetings
Knowledge, Skills, and Abilities:
• Strong understanding of GLP-compliant bioanalytical workflows and method development.
• In-depth knowledge of global regulatory expectations (FDA, ICH, EMA) for PK and immunogenicity testing.
• Skilled in data interpretation and familiar with analytical/statistical software.
• Solid foundation in bioanalytical principles including concentration units, calibration curves, and quality controls.
• Proficient in laboratory operations: pipetting, balances, and digital tools.
• Experience with biological sample handling and automated liquid handling systems (e.g., 96-well format).
• Demonstrated expertise in ligand binding assay execution and troubleshooting.
• Excellent written and verbal communication skills with a collaborative and solutions-focused mindset.
• Strong organizational skills and ability to work effectively in a cross-functional team environment.
Education/Experience/ Licenses/Certifications:
• Bachelor's degree in relevant life sciences program field
• AND 6-8 years of relevant experience
Preferred: 4+ years in a CRO or GLP regulated laboratory environment
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Working Environment:
Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with
proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! ****************************
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at ***************. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Auto-ApplyProduct Development Scientist
Scientist job in Summit, NJ
A Product Development Scientist role involves a wide range of activities, including developing and optimizing new product formulations and processes, conducting laboratory testing and evaluations. Key responsibilities:
Include batching several iterations, ensuring technical accuracy in product development through stability studies, and documentation.
Working with the team, time management, attention to detail, strong analytical skills, strong communication, following the timeline.
Consumer Products - Skin Health
Education:
BA Degree
Experience:
2 to 4 years experience
Clinical Research Scientist
Scientist job in Summit, NJ
Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity.
To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com
Job Description
CORE JOB RESPONSIBILITIES:
Assist the Clinical Research team to interface with project team members including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data.
Assist with protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).
Assist with clinical study report preparation to include narrative writing
Participate in adhoc meetings
Qualifications
KNOWLEDGE/SKILLS/ABILITIES (KSA's):
Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), minimum 5 years' experience in clinical research development or equivalent
Oncology experience REQUIRED. Hematology experience is a plus. Protocol authoring is a plus. Data review and medical monitoring of data REQUIRED.
Minimum 5 yrs experience in oncology clinical development
Excellent written and verbal communication skills and interpersonal skills.
Knowledge of clinical trial design, basic statistics, and data review tools
Proficient at data interpretation
Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
Full understanding GCP and ICH Guidelines
Detail-oriented, well-organized
Ability to assimilate technical and scientific information quickly
Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus), JReview, EDC (Rave)
Demonstrated ability to work as part of a team
Additional Information
All your information will be kept confidential according to EEO guidelines.
IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP!
I look forward to hearing from you!
Clinical Research Scientist
Scientist job in Jersey City, NJ
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's
oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy.
Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide
leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion.
The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible.
Job Description
* Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory
submissions such as INDs.
* Author abstracts and manuscripts for publication in peer-reviewed journals.
* Evaluate and select potential investigative sites in collaboration with Clinical Operations staff.
* Ability to prepare, present and defend complex aspects of protocol design and/or study data at
investigator and internal meetings.
* Oversee and coordinate the collection of and/or collect pre-study documents
* Participate in data review and discrepancy resolution, team meetings/presentations with increasing
levels of independence and support the Program Clinical Leader or Sr. Management as needed.
* Assist in managing regulatory safety reporting with the following: SAE queries and follow-up,
annual reports, investigator brochures, ability to learn various databases.
* Critically review and synthesize complex information from reviews of the scientific and clinical
literature.
Qualifications
* Minimum 2-5 years of pharmaceutical industry clinical trial experience.
* Experience in immunology or endocrinology therapeutic areas is a plus.
* Primary experience with development of clinical trial protocols.
* Medical or scientific writing experience a must and familiarity with clinically applied science or
pharmaceutical development.
* Good understanding of FDA regulatory, ICH, and GCP requirements.
* Excellent communication skills, written and verbal.
* Superior interpersonal communication and the ability to work across company disciplines and functional units.
* Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines.
* Attention to detail and a commitment to high quality and on-time deliverables are key success factors.
* Willingness to travel up to 30% domestically and internationally.
Additional Information
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:
Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off
Auto-ApplyClinical Research Scientist
Scientist job in Iselin, NJ
Clinical Research Scientist Early Development We are seeking a motivated Clinical Research Scientist to join our Clinical Development team and support the execution of innovative clinical studies. This individual will work closely with senior scientists, physicians, and cross-functional partners to contribute scientific expertise, data insights, and clinical input across multiple programs.
Key Responsibilities
Assist in the design and development of study protocols and protocol amendments.
Contribute to the preparation of clinical and regulatory documents, including sections of INDs, study reports, investigator brochures, and updates for health authorities.
Provide scientific input into study tools such as case report forms, statistical analysis plans, and data output specifications.
Participate in the review and interpretation of clinical safety and efficacy data;support data monitoring activities throughout study conduct.
Collaborate with internal study teams and external partners (CROs, vendors, investigators) to ensure high-quality study execution.
Present study progress and scientific updates to project leadership and cross-functional committees.
Support preparation of data for abstracts, posters, presentations, and manuscripts.
Stay informed on evolving therapeutic landscapes, competitive intelligence, and standards of care relevant to assigned programs.
Qualifications
Advanced degree in a life science discipline preferred (Pharm.D., Ph.D., or equivalent).
1 3 years of experience in clinical research, with at least 1 year in drug development or industry setting.
Background in oncology or hematology is a plus.
Strong analytical skills and attention to detail, with ability to interpret and communicate complex data.
Excellent organizational, written, and verbal communication skills.
Ability to work effectively in a fast-paced, collaborative environment and manage multiple priorities.
Willingness to travel occasionally (up to ~20%).
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
Sr. Scientist - Beverages
Scientist job in Clark, NJ
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 highly skilled and innovative RD&A Scientist to join our Beverage team. This role is responsible for developing and optimizing beverage formulations across various formats including sparkling, still, juice, and functional beverages. The ideal candidate will bring deep technical expertise, strong sensory capabilities, and a collaborative mindset to drive product innovation and meet customer expectations.
Key responsibilities
Develop and prepare beverage formulations, syrups, and concentrates at lab and pilot plant scale.
Test and refine formulations to meet specific taste profiles and regulatory standards.
Customize beverage ingredients independently or within cross-functional teams.
Calculate calories and understand the role of sweeteners and nutrients in formulations.
Facilitate sample shipments for internal and external stakeholders.
Support beverage and taste development under GMP and safety standards.
Manage multiple tasks and deadlines with speed and accuracy.
Master formulation techniques for RTD (Ready-to-Drink) and RTM (Ready-to-Make) formats.
Apply exceptional sensory skills to define and discriminate flavor profiles under tight timelines.
Demonstrate a deep understanding of beverage processing techniques and nutritional value calculations.
Communicate formulation concepts effectively in commercial settings with customers.
Apply mathematical skills to work with dilutions, percentages, and ppm calculations.
Exhibit self-motivation and resourcefulness in solving complex formulation challenges.
Qualifications and skills
Bachelor's Degree in Food Science, Biology, Chemistry, or a related Applied Science.
Minimum of 5 years of experience in beverage development and formulation.
Strong scientific and analytical aptitude.
Proficiency in Microsoft Office; experience with SAP is a plus.
Excellent problem-solving skills and ability to work independently and collaboratively.
The typical hiring range for this role is $75,602 to $123,432 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.
Formulation Scientist/Engineer
Scientist job in Raritan, NJ
Formulation Scientist
Kelly OCG has an opportunity for a Formulation Scientist for our client a leading medical device company in Raritan, NJ. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts. This role is a full-time, fully benefited position. As a Kelly OCG employee, you will be eligible for Medical, Dental, 401K and paid time off, including holiday, vacation and sick/personal time.
Length of assignment one year
Must provide your own laptop
Day shift
Hybrid - 3 days on site
Pay $50-55 an hour depending on experience
Responsibilities:Leads formulation design efforts from concept through to prototyping phases, Design Reviews and Validation
Collaborate with external suppliers and internal partners to develop products
Drive product characterization to ensure rigorous technical understanding and relationships to pre-clinical/clinical outcomes
Lead raw material suppliers through raw material iterations, correlating to product design window
Drive execution of Learning Plans
Participate in multi-functional discussions and design reviews, including product creation at multiple scales (modeling, lab, pilot and manufacturing)
Participate in clinical procedures and activities, translating learning into viable prototypes
Proven problem-solving skills using analytical technologies is preferred\
Experience with respect to PMA preferred Proven problem-solving skills using analytical technologies is preferred
Experience Design of Experiments (DOE) is preferred.
Experience in developing protocols and writing completion reports is preferred.
Experience developing combination (drug/device) medical devices products is preferred
Working knowledge of basic statistics is required.
Experience in vitro and ex vivo methods for characterizing prototypes and products is preferred
Experience in developing and validating biochemical test methods for finished products and raw materials is preferred
Excellent communication, collaboration and influencing skills
Demonstrated ability to deliver project outcomes in an ambiguous environment
Requires experience managing self-directed work teams
Travel up to 20% may be required (domestic and international)
QualificationsEducation:
Minimum Bachelor's degree required; advanced degree (Ph D) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Polymer Science, Polymer Engineering, strongly preferred
Experience in medical device development is required 5 -10 years ideally
Successful experiences in launching new products & formulations to market is required. Experience in biomaterials and material development highly preferred
P#1
Physics PhD (Top 30 Program, US/UK/CA)
Scientist job in Newark, NJ
Mercor is collaborating with a leading AI research group to engage experts with advanced training in physics. **PhD graduates in Physics from a US/UK/CA top 30 pure physics program** are encouraged to participate. This cutting-edge project focuses on strengthening AI systems' reasoning capabilities through rigorous problem-solving and theorem-based evaluation. You will be applying graduate-level expertise to assess and validate complex mathematical reasoning. **Key Responsibilities** - Solve and evaluate challenging physics problems across diverse fields - Review AI-generated proofs and solutions for correctness and rigor - Provide structured feedback to improve mathematical reasoning models **Ideal Qualifications** - **PhD in Physics (not applied physics or engineering)** - Graduated from a **top 30 physics program in the US, UK, or Canada** - Ideally active in research/academia - Strong background in advanced problem-solving, with ability to clearly articulate articulate reasoning, reference theorems, and identify gaps in writing **More About the Opportunity** - Remote and asynchronous - set your own schedule - Flexible, project-based engagements - 5-6 week engagement with potential for additional opportunities **Compensation & Contract Terms** - Competitive hourly compensation, commensurate with your background & experience - Independent contractor arrangement - Payments processed weekly via Stripe Connect **Application Process** - Submit your resume and complete an interview to get started (if we do not have one already on file) - Qualified applicants will receive follow-up within a few days with next steps **About Mercor** - Mercor is a talent marketplace connecting top experts with leading AI labs and research organizations - Backed by Benchmark, General Catalyst, Adam D'Angelo, Larry Summers, and Jack Dorsey - Thousands of professionals across domains such as law, engineering, research, and creative services contract with Mercor to contribute to frontier AI projects
Chemist I/II/III- AR&D
Scientist job in West Caldwell, NJ
Looking for candidates at Chemist I, II and III levels responsible for carrying out analytical method validation/verification activities and testing for Oral Solids, Oral Liquids, Topicals and Powders.
MAJOR DUTIES/RESPONSIBILITIES:
Develop/Validate/Verify analytical (HPLC, GC, ICP-MS/OES, other) methods for assay and impurities determination in drug substances and drug products.
Perform wet chemistry and chromatographic testing for raw materials and products under development phase
Perform stability studies for drug products in development phase and generate reports
Develop and validate cleaning methods and generated study protocols and reports
Prepare relevant protocols, reports, and final methods
Maintain proper instrument calibration status
Ensure that work is carried out safely and in compliance with the organization's quality system
Ensure that quality documentation is generated and updated to reflect current best practice in a timely manner.
Perform peer review at Chemist III level, not required if you're applying for Chemist I/II levels.
Perform other duties as assigned.
MINIMUM/PREFERRED REQUIREMENTS:
Education:
Bachelor or Master's degree in science or Pharmaceutics.
Experience:
Bachelor's with 2-7 years of experience in a generic pharmaceutical analytical lab. Master's is preferred. Candidates shall be considered for different positions based on educational qualification and experience. Good understanding of cGMPs is a must for experienced candidates.
PHYSICAL DEMANDS/ENVIRONMENTAL CONDITIONS:
Laboratory and office environment
Able to lift about 25 pounds.
Able to stand and or sit for longer period of time.
On-site, Full-time, Day Shift