Biogen
Scientist II, Parenteral Drug Product Development
Cambridge, MA, USA · Mid
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About the role
- Biogen is presently looking to fill a Scientist II position within its Parenteral Formulation and Drug Product Development group.
- Candidate is expected to work collaboratively in a matrix environment with other members of the technical development team.
Responsibilities
- Design and execute formulation and process development studies supporting preclinical and clinical drug product development, with opportunities to support commercial development activities.
- Provide technical support during GMP manufacturing campaigns, engineering runs, process validation, and PPQ activities.
- Collaborate with drug substance, analytical development, device engineering, manufacturing sciences, quality, regulatory, and external manufacturing organizations to support program objectives.
- Support development and evaluation of primary container closure systems, including vials, prefilled syringes, and other delivery systems.
- Support evaluation of manufacturing equipment, single-use systems and filters for drug product development and manufacturing.
- The candidate will be responsible for formulation and process development activities of parenteral drug product programs to support Biogen's growing pipeline.
Requirements
- 4 years experience in pharmaceutical or biotech settings.
- OR M.S. degree with 4+ years of relevant experience
- OR B.S. degree with 6+ years of relevant experience
- You have general knowledge of parenteral drug product development and manufacturing.
- Your dedication to excellence and your ability to adapt to a dynamic, matrixed organization will be key assets in achieving our collective goals.
- Who You Are
- You have general knowledge of parenteral drug product development and manufacturing. You will be part of a dynamic drug product development group consisting of scientists and engineers. You will be working closely with the Pharma Process Development and Regulatory CMC team as well as R&D, Manufacturing and Quality teams to support development activities of Biogen oligonucleotide programs. You have passion for learning and proactive attitude to drive success in your new role. You enjoy and thrive in a fast-paced team/matrix environment as well as working independently to manage priorities and maintain project timeline. Your dedication to excellence and your ability to adapt to a dynamic, matrixed organization will be key assets in achieving our collective goals.
- Education Requirements:
- Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, Analytical Chemistry or related fields with 0 - 4 years experience in pharmaceutical or biotech settings.
- Required Skills:
- Demonstrated experience with pharmaceutical drug product development, preferably sterile drug product development and parenteral formulations. Hands-on experience with oligonucleotide, peptide, antibody, or conjugated therapeutics is preferred
- Understanding of drug product manufacturing process operations including mixing, sterile filtration, aseptic filling, lyophilization, and container closure systems.
- Experience authoring technical reports, protocols, and other CMC documentation
- exposure to regulatory submissions such as IND, IMPD, or NDA is preferred.
- Experience with process validation, PPQ, engineering batches, technology transfer, and authoring technical reports, validation documents, and regulatory submissions.
Nice to have
- Demonstrated experience with pharmaceutical drug product development, preferably sterile drug product development and parenteral formulations.
- Hands-on experience with oligonucleotide, peptide, antibody, or conjugated therapeutics is preferred
Skills
- Experience planning and executing laboratory experiments, analyzing data, and drawing scientifically sound conclusions.
- Experience with analytical and characterization techniques used for sterile drug products.
- Experience in analytical and characterization techniques used for characterization of sterile drug products
- Experience formulating biologics, including high-concentration protein formulations is a plus.
- Experience supporting technology transfer, engineering batches, process validation, or PPQ activities is highly desirable.
- Job Level: Management
- Additional Information
Compensation
- Tuition reimbursement of up to $10,000 per calendar year
Benefits
- Medical, Dental, Vision, & Life insurances
- Paid Maternity and Parental Leave benefit
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Employee stock purchase plan
- Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Company info
- You will be part of a dynamic drug product development group consisting of scientists and engineers.
- We are a global team with a commitment to excellence, and a pioneering spirit.
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 401(k) program participation with company matched contributions
- As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
This listing is sourced directly from Biogen's careers page and normalized into a canonical job model.