The Senior Manager, CMC Project Management will function as a Project Manager for the CMC programs in early development. He or she will work closely with external CMO and internal cross-functional teams to advance the assigned programs in the development portfolio.
- Lead project management efforts associated with drug substance/drug product manufacturing, release, and related regulatory filings (IND, CTA, IMPD, etc.) to advance the company’s pipeline of products.
- Coordinate multiple CMC projects simultaneously and provides communication to external CROs/CMOs, including participation in technical calls and face-to-face meetings, development of agendas, creation of meeting minutes, tracking of action items, and scheduling of follow-up meetings.
- Facilitate cross-functional planning of CMC activities across departments and disciplines to align dependencies, schedules, budgets and project deliverables.
- Proactively identify potential risks, resource constraints, and conflicts that could impact project timelines; collaborate within the development team to develop appropriate solutions.
- Schedule and conduct internal CMC team meetings and ensure regular, effective communication within the team and with key stakeholders (i.e., prepares draft meeting minutes and tracks action items).
- Support writing, review, publication and filing of CMC related regulatory documents and interactions, including those associated with INDs, CTAs, IMPDs, NDAs and PAIs.
- Within the PM role, support manufacturing process improvements, process validation, analytical method development & transfer, and product launch related activities
- Assist as needed in preparing presentations, updating corporate project plans, updating CMC project budgets, etc.
- Other duties as assigned.
- BS or MS (preferred), 5+ years’ experience within the Biotech/Pharma space; familiarity with GMP operations is preferred.
- Demonstrated ability to manage multiple projects simultaneously and to work effectively with external contract organizations and within cross-functional internal teams.
- Displays initiative in daily work and accepts ownership of project outcome, uses personal leadership style to foster trust, confidence, and collaboration.
- Familiarity with manufacturing and technology transfer activities. Demonstrated ability to work within a rigorous quality system is essential.
- Displays strong analytical and problem-solving skills.
Job Location: Remote
Equal Opportunity Employer
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