Principal Engineer
About The Position
Join the Alkermes Process Development team as a Principal Engineer, where you will lead late-stage drug product Process Development activities at internal and external manufacturing sites. You will be responsible for providing technical guidance and driving execution for small molecule process development, scale-up and technical transfer to manufacturing from Phase 3 up to PPQ. You will play a key role in the CMC team and work closely with the Operations organization. This role will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs.
Requirements
- Late-stage drug product Process Development activities
- Small molecule process development
- Scale-up
- Technical transfer to manufacturing from Phase 3 up to PPQ
- Experience in a CMC team
- Experience working closely with Operations organization
- Experience in a highly collaborative matrix team environment
Responsibilities
- Lead late-stage drug product Process Development activities at internal and external manufacturing sites.
- Provide technical guidance and drive execution for small molecule process development, scale-up and technical transfer to manufacturing from Phase 3 up to PPQ.
- Play a key role in the CMC team.
- Work closely with the Operations organization.
- Drive critical decision-making in a highly collaborative matrix team environment.
- Ensure the successful development of new drugs.
Benefits
- Great Place to Work certification in the U.S.
- Massachusetts’ Top Places to Work
- Best Place to Work in Greater Cincinnati
- Best Place to Work in BioPharma
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
No Education Listed
