Parenteral Formulation Scientist I

Biogen, Inc.; Cambridge (MA); On-site; USD 103,000 - 134,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness reimbursement

Paid vacation and holidays

401(k) matching

Job summary

Biogen, Inc. is seeking a Scientist I/II to join the Parenteral Formulation and Drug Product Development group.

The role focuses on designing and executing formulation and process development studies for parenteral drug products across preclinical to clinical stages. The candidate will collaborate with multiple functions to support manufacturing campaigns, technology transfer, and regulatory submissions, while contributing to device and container closure system evaluations and nonclinical drug

Qualifications

• 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 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 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.
• Experience in analytical and characterization techniques used for characterization of sterile drug products.
• Demonstrated ability to work independently on assigned technical activities, solve scientific problems, and effectively collaborate 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, 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.
• Prepare and coordinate drug product supply for nonclinical studies.
• Author technical reports, development protocols, and other CMC documentation supporting regulatory submissions.

Skills

Parenteral formulation

Sterile formulation

Aseptic filling

Process development

Analytical techniques

Team collaboration

Regulatory submissions

Independent work

PPQ/tech transfer

Education

Ph.D. in Chemical Engineering

M.S. in related field

B.S. with relevant experience

Job description

Biogen, Inc. is seeking a Scientist I/II to join the Parenteral Formulation and Drug Product Development group.

The role focuses on designing and executing formulation and process development studies for parenteral drug products across preclinical to clinical stages. The candidate will collaborate with multiple functions to support manufacturing campaigns, technology transfer, and regulatory submissions, while contributing to device and container closure system evaluations and nonclinical drug