FSP Scientist: GxP Raw Materials Methods and Testing Full-time

Scientist

Join us as a Scientist! 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.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

As a Scientist, your role will be to perform advanced diagnostic testing and analysis, ensure the accuracy and reliability of laboratory results, troubleshoot complex technical issues, and contribute to the continuous improvement of lab procedures and quality standards.

A versatile, pharmaceutical product development GMP laboratory seeks a hardworking, results-focused analytical chemist to support biologics pharmaceutical manufacturing. The position will require relevant expertise in compendial, spectroscopic (vibrational and UV), chromatographic, and physical testing of raw materials and excipients used in the manufacturing and formulation of biologic drug substances and drug products. This position will be located in New Brunswick, NJ, reporting directly to a Senior Scientist within the GxP Raw Materials Group of the Analytical Strategy & Operations (ASO) department.

Education and Experience:

• The candidate must have a B.S. or equivalent with a degree in Analytical Chemistry, Chemistry, Biochemistry or equivalent; at least two (2) years of analytical laboratory experience in a Quality Control (QC) and GMP environment is strongly preferred.

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-4 years).

• Familiarity with ICH and compendial procedures and guidelines is preferred as is an understanding of cGMP/GLP and GDP practices and EHS requirements. The ability to comply with all applicable SOPs and regulatory requirements is a must and essential for success in this position.

• The candidate must be able to deliver when working under assigned timelines and demonstrate good time management and communication skills, particularly in documentation of data and writing reports and methods. Skill in communicating/escalating critical issues to appropriate team leaders and functional area management is necessary.

• Expertise in MS Office applications, in particular MS Word and Excel, is required. Familiarity with electronic documentation systems and scientific reporting applications (e.g., LIMS, Empower software, ELN/eNotebooks, Infinity) for documenting experiments and routing protocols/reports for review and approval is a plus.

Duties and Responsibilities:

• Demonstrate practical knowledge of analytical techniques contributing to the development of phase-appropriate robust and reproducible analytical methods used in a GMP testing laboratory.

• Support the development of analytical test methods for raw materials through feasibility/assessment testing, study design, and the execution and authoring of relevant protocols and reports.

• Independently execute analytical method qualifications, validations, and transfers (as applicable) of raw material test methods to QC laboratories, carefully adhering to approved protocols.

• Independently perform analytical testing including but not limited to HPLC, vibrational (FTIR, NIR, Raman) and UV spectroscopic methods, Titration assays, pH and Osmolality measurements, compendial methods and general wet chemistry techniques, and general physical description tests (color & appearance). Executed tests support clinical release and stability testing of drug substances, drug products, excipients and raw materials used in the manufacturing and formulation of clinical biologics drug substances and drug products.

• Maintain clear, complete, accurate and GMP-compliant documentation for experiments.

• Proactively provide clear, timely communication of potential issues to management.

• Organize and present data for internal meetings involving relevant technical and scientific work and issues.

Working Conditions and Environment:

• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.

• Occasional drives to site locations, occasional domestic travel.

• Exposure to biological fluids with potential exposure to infectious organisms.

• Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.

• Personal protective equipment required such as protective eyewear, garments and gloves.

• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements:

• Ability to work in an upright and /or stationary position for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.

• Occasional mobility needed.

• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

• Frequently interacts with others to obtain or relate information to diverse groups.

• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

• Regular and consistent attendance.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.

Apply today to help us deliver tomorrow's breakthrough.

Compensation and Benefits:

The hourly pay range estimated for this position based in New Jersey is $30.14–$50.24.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount