Project Manager, External Manufacturing (CMO Site Selection)
Regeneron
18 days ago
On-site
East Greenbush, NY
Operations
Project Manager (External Manufacturing)
Responsibilities:
- Lead evaluation and execution of technology transfer projects from IND Project Approval (IPA) through CMO selection, aligned with life cycle management strategy.
- Manage planning and execution of deliverables for External Manufacturing projects for molecule-specific programs (Technical Transfers, Process Validation, new CMO selection, CapEx).
- Serve as single point of contact for project communications with CMOs and internal stakeholders (including the CMC Program Manager).
- Lead cross-functional teams; prioritize activities using strong organizational, communication, and time-management skills.
- Ensure stakeholders align on a single External Manufacturing project plan.
- Plan and track project activities, coordinating contingency and risk mitigation throughout the project lifecycle.
- Facilitate regular project-focused meetings with CMOs and working teams.
- Ensure meeting minutes and weekly/monthly reports are completed and distributed.
- Provide flexible project management support across the External Manufacturing portfolio as business needs evolve.
Qualifications:
- Strong project management and interpersonal skills, including cross-cultural communication, negotiation, and problem-solving.
- Ability to give clear direction in ambiguous environments.
- Ability to proactively resolve project issues with tact and composure.
- Resilient and flexible under challenge.
- Ability to understand and listen to stakeholders while fostering teamwork toward a common objective.
- High emotional IQ.
- Knowledge of industry practices and regulations (e.g., GxP, ISO, ICH).
- Technical expertise contributing to new concepts, techniques, and standards.
- Proficiency with MS Project, Excel, PowerPoint, Word, and experience in shared work environments.
- Bachelor’s degree in physical or biological science.
- Experience: Project Manager—10 years (Associate Project Manager—8 years). May substitute proven experience for education.
Application Instructions:
- Apply now to take your first step toward living the Regeneron Way.
Responsibilities:
- Lead evaluation and execution of technology transfer projects from IND Project Approval (IPA) through CMO selection, aligned with life cycle management strategy.
- Manage planning and execution of deliverables for External Manufacturing projects for molecule-specific programs (Technical Transfers, Process Validation, new CMO selection, CapEx).
- Serve as single point of contact for project communications with CMOs and internal stakeholders (including the CMC Program Manager).
- Lead cross-functional teams; prioritize activities using strong organizational, communication, and time-management skills.
- Ensure stakeholders align on a single External Manufacturing project plan.
- Plan and track project activities, coordinating contingency and risk mitigation throughout the project lifecycle.
- Facilitate regular project-focused meetings with CMOs and working teams.
- Ensure meeting minutes and weekly/monthly reports are completed and distributed.
- Provide flexible project management support across the External Manufacturing portfolio as business needs evolve.
Qualifications:
- Strong project management and interpersonal skills, including cross-cultural communication, negotiation, and problem-solving.
- Ability to give clear direction in ambiguous environments.
- Ability to proactively resolve project issues with tact and composure.
- Resilient and flexible under challenge.
- Ability to understand and listen to stakeholders while fostering teamwork toward a common objective.
- High emotional IQ.
- Knowledge of industry practices and regulations (e.g., GxP, ISO, ICH).
- Technical expertise contributing to new concepts, techniques, and standards.
- Proficiency with MS Project, Excel, PowerPoint, Word, and experience in shared work environments.
- Bachelor’s degree in physical or biological science.
- Experience: Project Manager—10 years (Associate Project Manager—8 years). May substitute proven experience for education.
Application Instructions:
- Apply now to take your first step toward living the Regeneron Way.