Parenteral Formulation Scientist II

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

Benefits offered by this job

Medical, Dental, Vision

401(k) with company match

Stock purchase plan

Job summary

Biogen is seeking a Scientist II to join its Parenteral Formulation and Drug Product Development group. You will design and execute formulation and process development studies for parenteral drug products, supporting preclinical to clinical programs and technology transfer.

You will collaborate across teams to optimize sterile products, oversee container closure systems, and contribute to regulatory submissions.

Qualifications

• PhD with 0–4 years pharma/biotech exp.
• MS with 4+ years relevant exp.
• BS with 6+ years relevant exp.

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

Sterile parenteral formulations

Process validation

Technology transfer

Analytical methods

Regulatory submissions

Oligonucleotide therapies

Independent problem solving

Aseptic filling

Lyophilization

Education

PhD in Chemical Eng

MS in Pharmaceutical Sciences

MS in Pharmaceutics

BS in relevant field

Job description

Biogen is seeking a Scientist II to join its Parenteral Formulation and Drug Product Development group. You will design and execute formulation and process development studies for parenteral drug products, supporting preclinical to clinical programs and technology transfer.

You will collaborate across teams to optimize sterile products, oversee container closure systems, and contribute to regulatory submissions.