Summary: The CMC Project Manager works collaboratively with CMC team leaders towards achieving project goals by providing project management expertise.
- Proactively manage the CMC project schedules with a focus on effective planning, coordination of activities, and communication to ensure effective and efficient operational implementation of CMC strategy.
- Enhance delivery of Akero’s CMC objectives by fostering strong CMO/CRO relationships
- Use key project management tools to plan and track project deliverables.
- Identify critical path activities and coordinate with responsible parties to ensure deliverables are achieved. Facilitate resolution to keep project activities on track.
- Manage CMC internal and outsourced activities for specified projects at all development stages, interfacing with relevant functional groups, and with external suppliers as necessary.
- Facilitate CMC Team meetings and be responsible for effective and efficient conduct and follow through. Provide monthly updates to CSO and CDO on status of critical path CMC activities
- Establish effective working relationships with project management counterparts at CDMOs
- Assist with tracking of the movement of drug, intermediates and samples for analytical testing between external partners
- Interface with other project managers (e.g. clinical) to integrate CMC plans with overall plans and ensure planning, coordination and communication to enable timely supply of materials and information of the required quality standard.
- Coordinate preparation and review of CMC regulatory filings.
- Assist Heads of Process and Product Development, and Financial Controller in CMC project budget planning and tracking, including invoice payments, accruals and reforecasting as needed.
- Assist COO-General Counsel and VPs Process and Product & Device Development in circulating RFPs, establishing contracts, amending and approving work programs.
Technical Requirements & Skills
- Biopharmaceutical CMC experience covering pre-IND candidate development through BLA. High level knowledge of regulatory agency (FDA, EMEA, Japan) guidelines for biopharmaceutical CMC packages
- Proven track record of successfully managing CMC projects in development. Strong record of delivery in early stages (pre-Ph3) of CMC development (biologicals development).
- Prior experience overseeing a complex, high-tech manufacturing environment and interacting directly with Contract Research Organizations and Contract Manufacturing Organizations.
- Agile learner, able to move effectively between detail and project strategy
- Demonstrated ability to work in teams, to build strong relationships and to lead by influence. Sophisticated interaction style across cultures
- Adaptable and flexible team-player comfortable with ambiguity in fast-moving, dynamic environments
- Excellent project integration, planning, communication and documentation skills. Familiarity with planning tools (Microsoft Project, Excel, PowerPoint and Outlook).
- This position is located in South San Francisco, California and may require domestic or international travel as required (valid travel documents must be obtainable).
- S. degree in a scientific discipline; additional/postgraduate qualifications (Pharm D, MS, PhD; PMP, MBA) will be a distinct advantage.
- 4-6+ years project or program management experience within the pharmaceutical or biotech industries; experience managing projects with remote teams and through external alliances preferred.