Sr. NPI Programs Manager, Biologics Manufacturing (Remote)
Amgen
Turn this role into an interview — a resume and cover letter built around what this employer wants.
Job summary
Amgen North Carolina is seeking a Manufacturing Programs Senior Manager for New Product Introduction (NPI). You will interface between GMP manufacturing teams and Process Development to ensure successful tech transfers into the Biologics Drug Substance facility.
This high-visibility role drives cross-functional deliverables and Lean initiatives to improve productivity. We expect strong cross-functional project management, leadership, and communication skills, plus a background in biologics
Qualifications
- Must have bios/pharma operations experience with team leadership.
- Experience coordinating NPI, tech transfers and cross-functional projects.
- Strong written and verbal communication across levels.
- GMP manufacturing knowledge and problem-solving skills.
Responsibilities
- Coordinate with Manufacturing, Process Development, Supply Chain, Planning and other teams to introduce new Drug Substance products and technologies.
- Lead a team of NPI manufacturing specialists and drive cross-functional deliverables.
- Facilitate problem-solving, RCAs, CAPA development, and continuous improvement.
- Ensure production documents are accurate and up to date.
- Support Lean Transformation and operational excellence initiatives across the plant.
- Mentor staff and build a culture that thrives.
Skills
Education
Job description
Amgen North Carolina is seeking a Manufacturing Programs Senior Manager for New Product Introduction (NPI). You will interface between GMP manufacturing teams and Process Development to ensure successful tech transfers into the Biologics Drug Substance facility.
This high-visibility role drives cross-functional deliverables and Lean initiatives to improve productivity. We expect strong cross-functional project management, leadership, and communication skills, plus a background in biologics
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
