Sr Assoc Scientist, Drug Product Process Development
Regeneron Pharmaceuticals
Summary
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Sr. Associate Scientist to join our Drug Product Development and Technology Group (DPDT) Process Development Team. In this role, you will support drug product process development studies for biologics, including traditional monoclonal antibody (mAb) and non-traditional modalities (e.g., AAV, antibody tethered ligand, etc.), working closely with DPDT leads and scientists to ensure seamless technology transfer to various manufacturing sites and provide technical support toward GMP manufacturing, validation campaigns, and post-launch activities.
Job description
What you'll do
- Plan, optimize, design, and execute drug product process development studies to ensure robust characterization of different unit operations (freeze/thaw, lyophilization, mixing, filtration, filling, etc.)
- Assist in developing small-scale models to effectively mimic manufacturing unit operations and support technology transfer to manufacturing teams
- Support in-house drug product toxicological lot manufacturing campaigns as needed
- Work closely with DPDT leads/scientists to ensure seamless progression of multiple late-stage process-related activities
- Prepare, review, and edit technical reports
- Bring in new ideas from literature and present work at group, department, and cross-functional meetings
- Manage process development equipment installation, operation, maintenance, calibration, and repairs
The environment and physical rhythms of this role
- This is a fast-paced laboratory environment requiring the ability to work effectively both independently and within a team environment.
- Capacity to multitask and quickly adapt to changes in priorities, with strong initiative to complete challenging tasks and learn new technologies, is required.
Must-haves
- BS degree in Biomedical or Chemical Engineering, Pharmaceutical Sciences, or a related field with 6+ years of relevant industry experience, or an MS degree with 3-6+ years of relevant industry experience
- Experience with drug product development and characterization (formulation and process)
- Hands-on experience with analytical instruments used for biologics, including HPLC-based chromatographic techniques (icIEF, SEC, IEX), biophysical methods (DLS, DSC, and UV-Vis), and particle characterization methods (MFI and HIAC)
- Basic understanding of common protein degradation pathways and biophysics
- Demonstrated strong and proactive problem-solving skills via critical thinking and effective communication
Preferred / nice-to-haves
- Experience with lyophilization
- Other quantification methods (ddPCR, ELLA, mass photometry)
- Experience with statistical software (JMP) to perform design of experiments and statistical analyses
Requirements
- BS degree in Biomedical or Chemical Engineering, Pharmaceutical Sciences, or a related field with 6+ years of relevant industry experience, or an MS degree with 3-6+ years of relevant industry experience
- Experience with drug product development and characterization (formulation and process)
- Hands-on experience with analytical instruments used for biologics, including HPLC-based chromatographic techniques (icIEF, SEC, IEX), biophysical methods (DLS, DSC, and UV-Vis), and particle characterization methods (MFI and HIAC)
- Basic understanding of common protein degradation pathways and biophysics
- Demonstrated strong and proactive problem-solving skills via critical thinking and effective communication
- Experience with lyophilization
- Other quantification methods (ddPCR, ELLA, mass photometry)
- Experience with statistical software (JMP) to perform design of experiments and statistical analyses
Benefits
- Student Loan Paydown Program
- Tuition Reimbursement
- Family Care Benefits
- Relocation Assistance
- Inclusion, Culture & Well-Being Programs
- Annual Bonuses
- Equity Awards
- Pension/Retirement Benefits
- 401(k) Company Match
- Health & Wellness Programs
- Fitness Centers
- Insurance Benefits
- Paid Time Off
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.