Senior Engineer II/III, Small Molecule Formulation Development

  • Full-time
  • Region: US
  • Department: Technical Development

Job Description

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.

Qualifications

Required Skills

  • Senior Engineer II:
    • PhD (2+ years hands-on experience) in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Material Science, Engineering, Chemistry or related subject area
    • MS (6+ years commensurate experience may also be considered) in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Material Science, Engineering, Chemistry or related subject area
    • BS (8+ years commensurate experience may also be considered) in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Material Science, Engineering, Chemistry or related subject area
  • Senior Engineer III:
    • PhD (6+ years hands-on experience) in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Material Science, Engineering, Chemistry or related subject area
    • MS (10+ years commensurate experience may also be considered) in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Material Science, Engineering, Chemistry or related subject area
    • BS (12+ years commensurate experience may also be considered) in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Material Science, Engineering, Chemistry or related subject area

Preferred Skills 

  • Hands-on experience with unit operations involved in manufacture of oral solid dosages
  • Proficiency in data analysis using statistical software such as JMP, and the ability to build relevant process models to identify, characterize, and predict the variables that impact drug product attributes are a big plus
  • Experience in mechanistic modeling of drug product processes a plus
  • Experience in small molecule parenteral formulation and process development a plus

Additional Information

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.  

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