Director, CMC Project Management
New
P
ProKidneyBiotechnology, Cell Therapy
Remote; Winston-Salem, North Carolina, United StatesFull-TimeDirector
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- 12+ years of relevant biopharmaceutical industry experience with 6+ years of cell therapy experience
- Required Skills
- Project Management
Requirements
- Bachelor's degree in sciences or related field; Advanced degree (MS, PhD) preferred.
- 12+ years of relevant biopharmaceutical industry experience.
- 6+ years of experience in cell therapy.
- Prior background in CMC project management at a biotech or pharma company focused on biologics/cell & gene therapy.
- Experience leading project managers or a project management team.
- Technical understanding of the inter-disciplinary nature of cell therapy development.
- Proven track record of effective collaboration with cross-functional CMC teams.
- Ability to identify dependencies, risks, and gaps across manufacturing, quality, analytical, and regulatory activities.
- Ability to multi-task across product pipelines.
- High ethical standards and compliance focused.
Responsibilities
- Translate CMC strategy into project plans with defined deliverables and deadlines.
- Develop and track detailed CMC plans and milestones across Technical Operations.
- Facilitate CMC gap assessments, risk analysis, and cross-functional decision-making.
- Lead and prioritize a team of project managers supporting CMC projects.
- Report project status to leadership and maintain project documentation standards.
- Serve as the primary CMC point of contact for internal stakeholders.
- Collaborate on technology transfer, process scale-up, and validation activities.
View Full Description & ApplyYou'll be redirected to the employer's site
