Sr. Project Manager/ Leader ( CMC)
- CMC Program Manager will lead cross-functional teams within Technical Operations on multiple projects from inception through completion, coordinating activities to develop the physical product, manufacturing process, supply chain and regulatory files for successful launch and ongoing commercial supply.
- Ideal experience in Cell/Gene therapy, Biotechnology/large molecule would be prefered.
- Drive team accountability for deliverables, develop and deliver team recommendations to senior management, create and meet all project milestones
- Responsible for delivery of CMC activities up to and including new product launch and post launch improvements. Experienced skills with Process Scale-up, Technology Transfer, Assay Transfer as required, packaging/labeling and process improvements.
- Minimum of 10 years of directly relevant experience including participation in cross-functional project management activities; with 3-5 years of experience as a CMC project manager.
- Must have a relevant CMC and supply chain knowledge on developing, manufacturing and industrializing pharmaceuticals along with a thorough working knowledge of the Biotech or Gene therapy experience.
- Has led technical transfer activities to manufacturing sites (primary and/ or secondary
- PMP or a Project Management certification
- Science, engineering or related degree(s)
- Process Excellence or Six Sigma training
- Master’s degree or MBA or other advanced degree
Competitive compensation, paid bi-weekly.
Flexible paid company holidays
Paid time off
401(k) Retirement Plan. Company match is fully vested.
Medical and Dental Coverage
Employee Assistance Program (EAP)
Short and Long-Term Disability
All referrals are welcome! We have a very generous referral bonus program open to all!