FSP Scientist: GxP Raw Materials Methods and Testing

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

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.

What You’ll Do:

A versatile, pharmaceutical product development GMP laboratory seeks a hardworking, results-focused analytical chemist to support biologics pharmaceutical manufacturingThe 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.

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.

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