Associate Scientist III, Parenteral Drug Product Development

About This Role

Biogen is presently looking to fill an Associate Scientist III position within its Parenteral Formulation and Drug Product Development group. The candidate will contribute in the development of parenteral formulations and drug product manufacturing (DP) processes to support Biogen's growing pipeline. Candidate is expected to work collaboratively in a matrix environment with other members of the technical development team. The candidate must be motivated and innovative with exceptional analytical and communication skills.

What You'll Do

• Plan and execute laboratory experiments supporting formulation development, product characterization, process development and evaluation of new technologies.
• Independently manage assigned development activities while working under the guidance of senior scientists on more complex technical initiatives.
• Prepare formulations, perform laboratory studies, collect and analyze experimental data, and communicate findings to project teams.
• Author development protocols, perform data analysis, prepare technical reports, and documentation for support of CMC submissions.
• Maintain accurate laboratory records in accordance with Good Documentation Practices (GDP) and support activities in compliance with GLP requirements, as applicable.
• Collaborate with cross-functional partners including Analytical Development, Drug Substance Development, Manufacturing Sciences, Quality, Device Engineering, and Regulatory to support project objectives.
• Contribute to continuous improvement initiatives, laboratory organization, and implementation of new technologies.

• Experience working in a pharmaceutical or biotechnology laboratory environment.
• Familiarity with formulation development for pharmaceutical products, preferably sterile parenteral drug products.
• Experience performing laboratory experiments, analyzing experimental data, and documenting results using Good Documentation Practices (GDP).
• Working knowledge of laboratory instrumentation and analytical techniques used for characterization of drug products.
• Familiarity with sterile laboratory practices and aseptic techniques is preferred.
• Strong organizational skills with the ability to manage multiple assignments simultaneously.
• Excellent written and verbal communication skills and the ability to work effectively within cross-functional teams.

• Experience with sterile injectable drug product development.
• Experience working with oligonucleotide, peptide, biologic, antibody, or conjugated therapeutics.
• Familiarity with formulation characterization techniques including chromatography, particle analysis, spectroscopy, and physicochemical characterization.
• Experience with Design of Experiments (DoE), JMP, Minitab, or other statistical analysis software is a plus.

• Medical, Dental, Vision, & Life insurances
• 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)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation