Sr Scientist, Protein Formulations

Thermo Fisher Scientific • Wilmington, DE

1d • Onsite

About The Position

Join us as Senior Scientist! Role: Sr. Scientist, Protein Formulations This is a fully onsite role based at our customer’s site in Wilmington, DE . We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. 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. Summarized Purpose We are seeking a highly motivated Scientist to join our Drug Product Technologies team. This role will support the development of formulations and drug product processes for monoclonal antibodies and related biologics from early development through commercialization.

Requirements

• PhD in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related field
• 0 – 2 years of relevant experience in biologics formulation or drug product development (including graduate research)
• Hands-on experience with protein/antibody formulation development
• Understanding of protein aggregation/degradation mechanisms and stabilization strategies
• Experience with analytical techniques for biologics (e.g., SEC, IEX, CE, DSC, particle analysis)
• Experience with statistical analysis approaches (e.g., DOE, multivariate analysis)
• Strong problem-solving skills and ability to work independently and manage tasks effectively
• Highly organized with the ability to manage multiple tasks and priorities

Nice To Haves

• Experience with high-concentration protein subcutaneous product development
• Experience with prefilled syringes (PFS) or other container closure systems
• Experience with lipid-based nanoparticle formulations and delivery technologies
• Familiarity with ICH guidelines and regulatory requirements for biologics is a plus

Responsibilities

• Design and execute subcutaneous formulation development studies for monoclonal antibodies (e.g., buffer screening, excipient selection, stability assessment, device compatibility, in-vitro bioavailability assessment)
• Perform biophysical characterization (e.g., DLS, DSC, DSF) to investigate protein aggregation and degradation pathways
• Execute drug product development activities including fill-finish, container closure selection (e.g., vials, PFS, autoinjectors), compatibility studies, and support pilot batch manufacturing, scale-up, and technology transfer into GMP manufacturing
• Design and execute in-use compatibility studies to evaluate product quality under dilution, storage, and administration conditions
• Provide support for regulatory filings (e.g., IND, BLA, MAA) through assisting with CMC documentation and data compilation for submissions to global health authorities
• Coordinate and communicate with CROs and CMOs to support external studies, manufacturing activities, and project timelines
• Collaborate cross-functionally with analytical, process development, regulatory, and quality teams

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees