Pharmaceutical Project Manager - External Manufacturing

Job Title: Pharmaceutical Project Manager - External Manufacturing

Job Location: Indianapolis, IN

Job Type: Contract

Pay Range: $70.90hr - $75.90hr

Job Overview:

The organization is seeking a Project Manager to provide strategic and operational project leadership across API external manufacturing, supporting the management of commercial supply and related initiatives at a contract manufacturing organization (CMO). This role integrates activities across quality, supply chain, engineering, regulatory, and finance, translating program strategy into disciplined execution to ensure reliable commercial supply of key therapeutics.

Responsibilities:

The candidate is responsible for facilitating and supporting contract manufacturing organization (CMO) oversight and project delivery, including the following:

• Manage scope and support creation of an integrated project plan that articulates the strategy for the CMO relationship and its key initiatives, and provides the foundation for operational objectives and milestones.
• Coordinate cross-functional obligations between the organization and the CMO, including quality oversight, supply coordination, deviation/CAPA and change-control interfaces, and contract and governance commitments.
• Create and execute project plans and drive delivery of project milestones across the initiative lifecycle.
• Develop and implement team communication plans and drive communication of key decisions, risks, and results to stakeholders and leadership.
• Monitor and prioritize project and supply risks, suggest ways to avoid or mitigate risks, and initiate contingency plans as needed.
• Bring forward areas for continual process improvement to strengthen schedule discipline, reduce cost, and improve reliability of commercial supply and project delivery.
• Drive development of an integrated project budget and support financial governance, ensuring alignment with functional representatives, finance, and leadership.
• Maintain proficiency in self-management and organizational skills; the candidate must be able to manage workload, set personal and team priorities, and adjust as needed in a dynamic, multi-workstream environment.
• Demonstrate strong interpersonal and team-building skills; the candidate must be able to develop effective teamwork between the organization and CMO team members with diverse styles and across organizational boundaries.

Qualifications:

• Bachelor s degree in engineering, a scientific field, or a related technical discipline, and a minimum of 5 years of relevant experience in pharmaceutical/biopharmaceutical operations.
• Advanced degree or professional certification (e.g., MS, MBA, Master s in Project Management, PMP, or a commissioning/qualification/validation credential) preferred.
• Experience overseeing project lifecycle of commercial or external manufacturing at a contract manufacturer (CMO/CDMO), including quality oversight, supply coordination, deviation/CAPA and change-control interfaces, and contract governance.
• Demonstrated experience applying project management tools and processes scheduling, risk management, phase-gate/stage-gate governance across cross-functional teams spanning quality, supply chain, engineering, regulatory, and finance in a GMP environment.
• Proficiency with Microsoft Word, Excel, PowerPoint, and project scheduling tools (e.g., MS Project, Primavera P6, Smartsheet), and capable of maintaining appropriate project documentation.

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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities