The Project Manager is responsible for coordinating cross-functional activities associated with Contract Manufacturing Organizations (CMOs) and external supply partners. This role oversees project timelines, documentation workflows, quality event initiation, and the movement of materials and finished goods to ensure manufacturing programs are executed safely, compliantly, and on schedule.
The Project Manager serves as the primary point of contact between internal stakeholders and assigned CMOs. The role requires strong project management, communication, documentation, and problem-solving skills within a regulated pharmaceutical, biotechnology, medical device, or life sciences environment.
The responsibilities may include but are not limited to the following activities:
- Serve as the primary project management contact for assigned CMOs, suppliers, testing laboratories, and logistics partners.
- Develop and maintain integrated project plans and timelines covering manufacturing, testing, documentation, disposition, and shipment activities.
- Coordinate regular project team and CMO meetings, including preparation of agendas, meeting facilitation, documentation of decisions, and tracking of action items.
- Monitor project milestones, dependencies, risks, and resource constraints.
- Identify schedule risks and operational issues early, develop mitigation plans, and escalate concerns to appropriate stakeholders.
- Maintain project dashboards and communicate status, risks, decisions, and upcoming milestones to project leadership.
- Coordinate domestic and international shipments of raw materials, samples, drug substance, drug product, packaging components, and finished goods.
- Confirm material availability, release status, shipping dates, delivery requirements, and receiving-site readiness.
- Coordinate required shipping documentation, including packing lists, certificates of analysis, customs documentation, temperature-control instructions, and chain-of-custody records.
- Coordinate the preparation, review, approval, and issuance of controlled documents required to support manufacturing and supply activities.
- Manage document workflows for batch records, protocols, reports, specifications, certificates, shipping documentation, change controls, and related technical documents as needed.
- Experience with initiating deviations and other quality events when manufacturing, documentation, testing, storage, or shipment activities do not occur as expected is a plus.
- Coordinate with Quality Assurance and applicable subject matter experts to establish event ownership, immediate actions, investigation requirements, and target completion dates.
- Work closely with Quality Assurance, Quality Control, Technical Operations, Manufacturing, Supply Chain, Regulatory Affairs, Clinical Operations, Finance, and external partners.
- Facilitate timely decision-making by ensuring stakeholders receive accurate information and understand critical deadlines
Education:
Bachelor’s or Master’s degree in life sciences, engineering, supply chain, business, project management, or a related discipline.
Experience:
5+ years of relevant experience in pharmaceutical, biotechnology, medical device, or another regulated industry.
Project Management Professional certification or equivalent project management training/experience.
Demonstrated experience managing projects involving CMOs, external manufacturers, suppliers, laboratories, or logistics providers.
Proficiency with project planning, document management, collaboration, and tracking tools.
Understanding of current Good Manufacturing Practices and Good Documentation Practices.
Technical and Leadership Competencies:
- Project planning and execution
- CMO and vendor relationship management
- Quality and compliance awareness
- Controlled-document coordination
- Risk identification and escalation
- Shipment and logistics management
- Decision-making and problem-solving
- Clear and concise communication.
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