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Senior Engineer II, Small Molecule Product and Process Development
About This Role
We are seeking an enthusiastic and highly motivated scientist / engineer to join the small molecule formulation development team at Biogen. You will be responsible for the development of small molecule drug products and processes to support Biogen’s rapidly expanding pipeline, including formulation and process development, scale-up, technology transfer, and process characterization.
What You’ll Do
Participate in multidisciplinary team responsible for conducting process and formulation development of pipeline products and for supporting commercial products through life cycle management
Design, plan, execute and document formulation and process development studies, with an emphasis on oral solid dosages
Apply scientific/engineering principles and techniques to develop, characterize, and implement processes and next generation technologies to solve technical challenges
Provide support, as needed, to clinical drug product manufacturing through process capability analysis and product impact assessments for process changes/improvements and non-conformance investigations
Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
Who You Are
You enjoy driving the development of oral solid dose formulations and processes from bench to manufacturing scale and look for chances to provide innovative solutions to drug product technical challenges. You have great verbal and written communication skills and a can-do problem-solving attitude.
Required Education and Experience
PhD degree in Chemical Engineering, Bioengineering, or closely related field with 0-3 years of relevant experience in oral solid dosage development OR
Master’s degree in Chemical Engineering, Bioengineering, or closely related field with 4-6 years of relevant experience in oral solid dosage development
Experience in oral solid dosage formulation and process development, process characterization, technical transfer to manufacturing sites or CMOs, and regulatory filings
Hands-on experience with unit operations involved in manufacture of oral solid dosages
Experience in small molecule parenteral formulation and process development a plus
Demonstrated ability of utilizing innovative tools and approaches for formulation and process characterization and development
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.