Scientist I, Parenteral Drug Product Development

About This Role

Biogen is presently looking to fill a Scientist I/II 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 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.

Qualifications

You have general knowledge of parenteral drug product development and manufacturing. You will be part of a dynamic drug product development group consisting of scientists and engineers. You will be working closely with the Pharma Process Development and Regulatory CMC team as well as R&D, Manufacturing and Quality teams to support development activities of Biogen oligonucleotide programs. You have passion for learning and proactive attitude to drive success in your new role. You enjoy and thrive in a fast-paced team/matrix environment as well as working independently to manage priorities and maintain project timeline. Your dedication to excellence and your ability to adapt to a dynamic, matrixed organization will be key assets in achieving our collective goals.

Education Requirements

• Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, Analytical Chemistry or related fields with 0 - 4 years experience in pharmaceutical or biotech settings.
• OR M.S. degree with 2 to 4+ years of relevant experience
• OR B.S. degree with 4 to 6+ years of relevant experience

Required Skills

• 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.

Preferred Skills

• Experience formulating biologics, including high-concentration protein formulations is a plus.
• Experience supporting technology transfer, engineering batches, process validation, or PPQ activities 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.