Senior Scientist, Parenteral Drug Product Development

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

About This Role

Biogen is presently looking to fill a Senior Scientist position within its Parenteral Formulation and Drug Product Development group. The candidate will be responsible for formulation and process development activities of parenteral drug product programs to support Biogen's growing pipeline. Candidate is expected to work collaboratively in a matrix environment with other members of the technical development team. The candidate must be motivated and innovative with exceptional analytical and communication skills.

What You'll Do

• 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 closely with drug substance, analytical development, device engineering, manufacturing sciences, quality, regulatory, and external manufacturing organizations.
• Develop scientifically sound strategies for primary container closure systems, including vials, prefilled syringes, and other advanced delivery systems.
• Support selection, qualification, and compatibility assessment of manufacturing equipment, single-use systems, filters, and container closure systems.
• Prepare and coordinate drug product supply for nonclinical and clinical studies.
• Author technical reports, development protocols, validation protocols, regulatory submission documents, responses to health authority questions and contribute to global regulatory submissions.

Qualifications

Who You Are You have a strong understanding of parenteral drug product development and manufacturing. You are a collaborative and scientifically curious professional who enjoys solving complex technical challenges and advancing innovative therapies. You thrive in a fast-paced, matrixed environment where you can independently drive development activities while partnering across functions to achieve shared goals. You communicate effectively, exercise sound scientific judgment, and are motivated by delivering high-quality solutions that support the development of novel parenteral drug products. Your adaptability, initiative, and commitment to excellence make you a valuable contributor to a growing and evolving development organization.

Education Requirements

• Ph.D. in Chemical Engineering, Materials Science, Pharmaceutical Sciences, Pharmaceutics, Analytical Chemistry or related fields with 4+ years of experience in pharmaceutical or biotech settings.
• OR M.S. degree with 8+ years of relevant experience
• OR B.S. degree with 10+ years of relevant experience

Required Skills

• Demonstrated experience with sterile drug product development and parenteral formulations preferably with hands‑on experience with oligonucleotide, peptide, antibody, or conjugated therapeutics.
• Strong understanding of drug product manufacturing process operations including mixing, sterile filtration, aseptic filling, lyophilization, and container closure systems.
• Prior experience working in a biopharmaceutical product development environment or working with CDMOs and familiarity with GMP guidelines.
• Experience conducting technical risk assessments using quality‑by‑design principles.
• Experience with process validation, PPQ, engineering batches, technology transfer, and authoring technical reports, validation documents, and regulatory submissions including IND, IMPD, NDA and responses to health authority's questions.
• Experience in analytical and characterization techniques used for characterization of sterile drug products.
• Demonstrated ability to independently lead technical initiatives, solve complex scientific problems, and effectively collaborate across multidisciplinary teams.

Preferred Skills

• Experience with formulation development of proteins, antibodies, antibody‑drug conjugates, or other complex biologics is highly desirable.
• Experience in developing and analyzing drug delivery systems and targeted conjugate molecules is a plus.
• Knowledge of statistical software, design or experiment programming and general visualization of sophisticated data sets is a plus.

Job Level: Management

Additional Information

The base compensation range for this role is: $138,000.00-$184,500.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business