Parenteral Formulation Scientist II

Biogen, Inc.; Cambridge (MA); On-site; USD 117,000 - 157,000; Full time

Benefits offered by this job

Medical Insurance

401(k) with company match

Tuition reimbursement

Paid vacation

Job summary

Biogen is seeking a Scientist II to lead formulation and process development for parenteral drug products. The role emphasizes collaboration across matrix teams and internal/external partners to advance Biogen’s pipeline.

You will design studies, optimize formulations, and support manufacturing campaigns, tech transfers, and regulatory submissions. Strong analytical skills and a proactive, independent work style are essential in this fast-paced environment.

Qualifications

• Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, Analytical Chemistry or related fields with 0-4 years experience in pharmaceutical or biotech settings, or MS with 4+ years, or BS with 6+ years.
• Experience with sterile drug product development and parenteral formulations.
• Knowledge of drug product manufacturing operations including mixing, sterile filtration, aseptic filling, lyophilization, and container closure systems.
• 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 authoring CMC documentation; exposure to IND/IMPD/NDA is preferred.
• Experience with process validation, PPQ, engineering batches, tech transfer, and regulatory submissions.
• Ability to work independently and collaboratively across multidisciplinary teams.

Responsibilities

• Design and execute formulation and process development studies supporting preclinical and clinical drug product development, with opportunities to support commercial development activities.
• Contribute to development of sterile parenteral drug products, including formulation optimization, manufacturing process development, and technology transfer.
• Provide technical support during GMP manufacturing campaigns, engineering runs, process validation, and PPQ activities.
• Execute studies supporting formulation and process optimization, product and process characterization, and manufacturing robustness.
• Collaborate with drug substance, analytical development, device engineering, manufacturing sciences, QA, Regulatory, and external manufacturing 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.
• Prepare and coordinate drug product supply for nonclinical studies.
• Author technical reports, development protocols, and other CMC documentation supporting regulatory submissions.

Skills

Formulation development

Parenteral drugs

Analytical testing

Process development

Regulatory knowledge

Technical reporting

Education

PhD in Chemical Engineering

MS in related field

BS with relevant experience

Tools

GMP manufacturing

PPQ

Statistical software

Design of experiments

Job description

Biogen is seeking a Scientist II to lead formulation and process development for parenteral drug products. The role emphasizes collaboration across matrix teams and internal/external partners to advance Biogen’s pipeline.

You will design studies, optimize formulations, and support manufacturing campaigns, tech transfers, and regulatory submissions. Strong analytical skills and a proactive, independent work style are essential in this fast-paced environment.