Overview In this role you contribute to sterile parenteral formulation and drug product development, advancing Biogen's pipeline through collaborative, cross-functional work. You will design and execute development studies, support GMP campaigns, and help transfer technology to manufacturing. You'll work with diverse teams to optimize containers, processes, and drug products for preclinical to clinical programs. This position offers meaningful impact on product robustness and regulatory readiness in a fast-paced environment.
Compensation / Benefits- Medical, Dental, Vision insurance
- 401(k) with company match
- Tuition reimbursement up to $10,000/year
- Stock purchase plan
- Paid time off including holidays and parental leave
- Disability insurance
Responsibilities- Design and execute formulation and process development studies for preclinical and clinical programs, with potential to support commercial development
- Develop sterile parenteral products, optimize formulations, and advance manufacturing processes and tech transfer
- Provide technical support during GMP manufacturing campaigns, process validation, and PPQ activities
- Conduct studies for formulation/process optimization, product characterization, and manufacturing robustness
- Collaborate with drug substance, analytical development, device engineering, manufacturing sciences, quality, regulatory, and external manufacturing teams
- Support development and evaluation of primary container closure systems (vials, prefilled syringes, etc.) and manufacturing equipment
- Prepare and coordinate drug product supply for nonclinical studies; author CMC documents and regulatory submissions
Key requirements- General knowledge of parenteral drug product development and manufacturing
- Hands-on experience with oligonucleotide, peptide, antibody, or conjugated therapeutics preferred
- Understanding of drug product operations (mixing, sterile filtration, aseptic filling, lyophilization, container closure)
- Experience planning and executing laboratory experiments and data analysis
- Experience with analytical/characterization techniques for sterile drug products
- Experience authoring technical reports, protocols, and CMC documentation; exposure to IND/IMPD/NDA is preferred
- Experience with process validation, PPQ, engineering batches, technology transfer, and regulatory submissions
- Able to work independently and collaborate across multidisciplinary teams
- Collaborative mindset
- Proactive and fast-learning
- Strong communication skills
- Sterile drug product development
- Parenteral formulations and primary container systems
- Aseptic filling, sterile filtration, lyophilization
