Lead Parenteral Formulation Scientist

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

Job summary

Biogen in Cambridge, MA is seeking a Senior Scientist to lead formulation and process development for parenteral drug products across preclinical to commercial programs. You will design studies, optimize processes, and coordinate technology transfer with GMP manufacturing teams.

You will work in a matrix environment with analytical development, device engineering, quality, and regulatory groups to deliver robust, scalable products while mentoring junior scientists and driving innovative

Qualifications

• Ph.D. in Chemical Engineering, Materials Science, Pharmaceutical Sciences, Pharmaceutics or related fields with 4+ years of pharma/biotech experience
• MS with 8+ years of relevant experience
• BS with 10+ years of relevant experience
• Strong understanding of parenteral drug product development and manufacturing
• Experience with sterile drug product development and scale-up
• Familiarity with GMP guidelines and CDMOs
• Experience with risk assessments using quality-by-design principles
• Experience with process validation, PPQ, and regulatory submissions (IND, NDA)

Responsibilities

• Design and execute formulation and process development studies supporting preclinical, clinical, and commercial drug product development
• Lead 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, PPQ, and commercial manufacturing
• Lead studies supporting process characterization, process validation, manufacturing robustness, and lifecycle management
• Collaborate with drug substance, analytical development, device engineering, manufacturing sciences, quality, regulatory, and external manufacturing organizations
• Develop strategies for primary container closure systems (vials, prefilled syringes) and other delivery systems
• Support selection, qualification, and compatibility assessment of manufacturing equipment and containers
• Prepare and coordinate drug product supply for nonclinical and clinical studies
• Author technical reports, development protocols, validation protocols, regulatory submission documents, and responses to health authority questions

Skills

Parenteral drug product development

Sterile manufacturing processes

Quality-by-design principles

Process validation/PPQ

Regulatory submissions (IND/NDA)

Education

Ph.D. in Chemical Engineering/related field

M.S. in related field

B.S. with extensive experience

Job description

Biogen in Cambridge, MA is seeking a Senior Scientist to lead formulation and process development for parenteral drug products across preclinical to commercial programs. You will design studies, optimize processes, and coordinate technology transfer with GMP manufacturing teams.

You will work in a matrix environment with analytical development, device engineering, quality, and regulatory groups to deliver robust, scalable products while mentoring junior scientists and driving innovative