About This Role

Biogen is seeking a highly motivated scientist to join the Small Molecule Drug Product Development team to advance preclinical assets into clinical development and beyond to commercialization. The candidate will join the Pre-formulation sub-team and will have various responsibilities to support Biogen’s rapidly expanding pipeline.

What You’ll Do

• Independently design, develop, and document preclinical formulation (PK-PD, Tox, and others for various routes of administration) for small molecule drug candidates, especially for those that are poorly soluble.
• Perform thorough active pharmaceutical ingredient (API) characterization, stability, and compatibility studies. Screen for polymorph/salt/co-crystals and identify/select lead candidate for clinical development.
• Lead critical activities in the pre-formulation and formulation area and represent group in multidisciplinary project teams responsible for advancing preclinical and clinical pipeline.
• Provide support, as needed, to clinical drug product development and manufacturing through material assessment, stability, and compatibility studies.
• Drive and lead innovation in API molecular level/bulk properties understanding and formulation capabilities using various experimental, modeling, data analysis, and/or other techniques to improve API developability and commercialization.
• Author/review guideline technical protocols, reports, scientific papers, patent, and relevant regulatory sections in IND, IMPD, NDA, and other filings.

Who You Are

You have a broad understanding of (or enjoy driving) API characterization and preclinical formulation development and look for chances to provide innovative solutions to advance our preclinical pipeline. You have great verbal and written communication skills and a desire to be a part of a great collaborative team.

Required Skills

Scientist I

• MS (with at least 3 - 4 years of experience) in Pharmaceutical Science, Materials Science, Chemistry or Chemical Engineering, or related science field of experience required OR
• BS (at least 4 - 6 years of experience) in Pharmaceutical Science, Materials Science, Chemistry or Chemical Engineering, or related science field of experience required.

Scientist II

• PhD (with at least 0 - 4 years of experience) in Pharmaceutical Science, Materials Science, Chemistry or Chemical Engineering, or related science field of experience required OR
• MS (with at least 4+ years of experience) in Pharmaceutical Science, Materials Science, Chemistry or Chemical Engineering, or related science field of experience required OR
• BS (at least 6+ years of experience) in Pharmaceutical Science, Materials Science, Chemistry or Chemical Engineering, or related science field of experience required.

Preferred Skills 

• Proven record of successfully planning and executing projects and experiments in a timely manner. Familiarity working with complex laboratory operations and instrumentation including U/HPLC, PXRD, DSC, TGA, Raman, IR, SEM, PLM, etc.
• Good knowledge of small molecule API assessment, preclinical formulation development, and concepts involved in process. Hands-on experience with operations involved in preclinical formulation development.  
• Strong skills and understanding of various thermal characterization techniques and abilities to effectively utilize them in solving problems.    
• Proficiency in small molecule lipid-based formulation or designing experiments and analyzing data using statistical software such Design-Expert or familiarity with computational software’s such as Materials Studio or familiarity with and knowledge in high-throughput experimentation (HTE) in related area is a plus.

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.