Lead Senior Scientist, Parenteral Drug Product

Biogen, Inc.; Cambridge (MA); On-site; USD 138,000 - 185,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Equity incentives

Bonus program

Job summary

Biogen is seeking a Senior Scientist to advance parenteral drug product development, leading sterile formulation efforts and technology transfer. You will work across functional teams, drive process validation, and contribute to regulatory submissions in a fast-paced, matrix environment.

The role requires strong analytical and communication skills, PhD or MS with extensive experience, and a track record in GMP settings. The team supports diverse biologics programs and lifecycle enhancements.

Qualifications

• PhD in Chemical Engineering, Materials Science, Pharmaceutical Sciences, Pharmaceutics, Analytical Chemistry or related fields with 4+ years of experience OR MS with 8+ years OR BS with 10+ years.
• Demonstrated experience with sterile drug product development and parenteral formulations.
• Strong understanding of drug product manufacturing process operations including mixing, sterile filtration, aseptic filling, lyophilization, and container closure systems.

Responsibilities

• Design and execute formulation and process development studies for preclinical, clinical, and commercial programs.
• Lead development of sterile parenteral drug products, including formulation optimization and technology transfer.
• Provide technical support during GMP manufacturing campaigns, process validation, and regulatory submissions.
• Lead studies for process characterization, validation, and lifecycle management.
• Collaborate with drug substance, analytical development, device engineering, quality, regulatory, and external manufacturing teams.

Skills

Sterile parenteral development

Process validation & PPQ

Quality-by-design (QbD)

Cross-functional collaboration

Analytical characterization of sterile

Education

PhD in Chemical Engineering/Pharmaceutical Sciences

MS with 8+ years experience

BS with 10+ years experience

Tools

GMP guidelines familiarity

Sterile filling equipment

Technology transfer

Job description

Biogen is seeking a Senior Scientist to advance parenteral drug product development, leading sterile formulation efforts and technology transfer. You will work across functional teams, drive process validation, and contribute to regulatory submissions in a fast-paced, matrix environment.

The role requires strong analytical and communication skills, PhD or MS with extensive experience, and a track record in GMP settings. The team supports diverse biologics programs and lifecycle enhancements.