The CMC Project Manager will be responsible for managing the development plan and CMC department efforts as it relates to the product development lifecycle.
- Lead project management efforts associated with drug substance/drug product manufacturing, release, and related regulatory filings (IND, NDA/BLA, etc.).
- Supporting manufacturing process improvements, process validation, analytical method development and transfer, and product launch related activities in a PM capacity.
- Provide project coordination and communication in support of multiple CMC projects at 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 delivery commitments.
- Proactively identify potential risks, resource constraints, and conflicts that could impact project timelines; collaborate with the development team to develop appropriate solutions.
- Schedule, conduct and draft minutes for internal CMC team meetings and ensure regular, efficient team and stakeholder communication.
- Support writing, review, publication and filing of CMC related regulatory documents and interactions, including those associated with INDs, CTAs, IMPDs, NDAs and PAIs.
- Assist in preparing presentations, updating corporate project plans, CMC budgeting, etc.
- Other duties as assigned.
- BS or MS (preferred), 5+ years’ experience within the Biotech/Pharma space; familiarity with GMP operations would be preferred.
- Proven ability to work collaboratively and constructively with other functions in the development organization (primarily QA/QC, Regulatory Affairs, and/or Clinical).
- Knowledge of the biotechnology product CMC Projects, including state-of-the-art processes and instruments used to make material.
- Familiarity with large scale manufacturing and technology transfer activities. The ability to work within a quality system is essential.
- Exceptional analytical and problem-solving skills.
- Demonstrated ability to interact on multiple projects and work with external contract organizations.
- Solid communication skills; comfortable representing the company, including scientific understanding of the CMC activities, and provide that vision to internal and external communities.
- Shown to have initiative, leadership skills and personal leadership style that fosters trust, confidence, and collaboration.
- Open-minded and risk-tolerant; not afraid to express an opinion.
Job Location: Cambridge, MA
Equal Opportunity Employer
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