We are looking for a Sr. Principal Scientist, Tech Transfer to lead and support the transfer of development processes into GMP manufacturing, ensuring technical readiness, compliance, and operational success.
Requirements
- BS/BA in biotechnology, chemical engineering, biological sciences, or similar scientific discipline and 12+ years of relevant experience OR
- MS/MA in biotechnology, chemical engineering, biological sciences, or similar scientific discipline and 10+ years of relevant experience OR
- PhD in biotechnology, chemical engineering, biological sciences, or similar scientific discipline and 8+ years of similar experience noted above
- Working knowledge of GMP manufacturing environments and quality systems
- Experience authoring and executing technology transfer plans, protocols, and reports
- Understands process development, transfer, and validation and risk management principles
- Experience supporting external manufacturing partners (CDMOs)
- Familiarity with ICH Q8/Q9/Q10 guidelines
- Advanced understanding of process or product development strategies as well as current techniques and literature
- Good knowledge of cross-functional requirements related to drug development
- Ability to lead teams and direct development programs
- Excellent at strategic planning
- Maintains substantial knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
- Acts as a technical lead on various projects
- Applies understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areas
- May utilize working knowledge of other related disciplines to provide solutions to a wide range of difficult problems
- Ability to work as part of and lead multiple teams
- Good leadership, mentoring skills, and abilities typically leads junior levels and/or indirect teams
- Excellent interpersonal communication, problem-solving, and analytical thinking skills
- Sees broader picture and longer-term impact on division/company
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
- Excellent project management, strong project leadership skills
- Ability to influence all levels of the organization and external resources
Benefits
- retirement savings plan (with company match)
- paid vacation
- holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage
