Biogen Senior Engineer II / Scientist II, Drug Product Development in Cambridge, Massachusetts
About this Role As a member in Biogen’s Protein Drug Product Development team, the Candidate will be primarily responsible for supporting formulation, process and container development, technology transfer, and process characterization of parenteral drug products. This role will focus on leading the development of late-stage parenteral drug product processes. Note: this position may be based in either Cambridge, MA or RTP, NC What You’ll Do * * Lead drug product activities, including design and execution of process development studies * Technology transfer of parenteral processes to contract manufacturing organizations * Represent the drug product team in the CMC environment * Authoring of associated regulatory filings (IND/IMPD, BLA, etc.) *Who You Are * As an experienced drug product development professional; you have the ability to work innovatively, independently and to influence stakeholders. You have a passion for problem solving and enjoy thinking on your feet. Driven by curiosity, you seek to investigate and implement new technologies and/or business practices. *Required Skills * *Senior Engineer II Scientist II * Ph.D in Chemical Engineering, Pharmaceutical Sciences, Biochemistry or related discipline with 2+ years of hands-on experience in parenteral DP development * MS in Chemical Engineering, Pharmaceutical Sciences, Biochemistry or related discipline with 6+ years commensurate experience may also be considered. * Thorough understanding of aseptic fill-finish unit operations (i.e. filling, filtration, mixing, lyophilization etc.) and equipment for scale-down model development and process characterization. * Demonstrated experience in the development, scale-up and technology transfer of aseptic Drug Product manufacturing processes * Ability to travel domestically and internationally (15%) Preferred Skills * Experience representing functional area in the CMC environment and leadership of associated drug product development activities, including representing DP line on CMC teams and authoring regulatory filings (IND/IMPD, BLA, etc.) * Experience with pharmaceutical primary container closure development. * Experience in late-stage formulation development (i.e. formulation robustness, high concentration formulation development, etc.). * Ability to collaborate and provide leadership in a cross-functional environment. * Experience with biosimilar product development *Why Biogen? * 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.