The CMC Project Manager will support GMP manufacturing of AAV gene therapy at contract development and manufacturing organizations (CDMO), oversee contract testing labs, and help support the GMP batch record review process. This position will also support inventory management and manage external storage sites. This role will support all aspects of AAV GMP manufacturing, clinical trial drug supply, analytical assay development, and testing oversight. The role is responsible for actively contribut... more details
The CMC Project Manager will support GMP manufacturing of AAV gene therapy at contract development and manufacturing organizations (CDMO), oversee contract testing labs, and help support the GMP batch record review process. This position will also support inventory management and manage external storage sites. This role will support all aspects of AAV GMP manufacturing, clinical trial drug supply, analytical assay development, and testing oversight.
The role is responsible for actively contributing to the development and implementation of the strategies and timelines needed to achieve targets and goals, as well as managing all aspects of the manufacturing budget. This role involves cross-functional collaborations with other departments, such as Clinical, Regulatory, Quality Assurance, Translational Sciences, Finance, etc. The ideal candidate must be as comfortable with high-level strategy as with managing tactical operational details. Flexibility of thought and excellent problem-solving skills are critical.
Job Responsibilities
Leads internal project meetings to drive project progress and goal achievement
Maintains records to document all relevant communications related to projects
Builds and maintains project timelines; keeps stakeholders informed, aligned, and on-task to meet deliverables and milestones
Oversees project planning and manage day-to-day interactions with CDMOs and analytical CROs
Participates in regular meetings with contract organizations via teleconference or site visits as needed
Disseminates and facilitates information flow/exchange between our organization and contractors
Provides oversight and support for AAV manufacturing and analytical testing
Develops Key Performance Indicators (KPIs) to enable accountability for CDMOs and negotiate payments
Owns CMC related risks on risk register as applicable; identifies gaps and key risks; leads mitigation and contingency planning with project team
Manages scope changes in project execution and negotiates any necessary change orders
Partners with Quality Assurance to track and maintain manufacturing-related documentation
Works in close cooperation with Clinical Operations and Quality Assurance to ensure timely manufacturing, packaging, labeling, and shipping of supplies for the clinical trials
Manage the timely testing of product stability samples
Manage inventory management for raw materials, Investigational Product, supplies, and sample use
Works closely with Quality Assurance to provide support for batch documentation review, deviations and investigations, change controls, and CAPA’s to ensure the timely review and release of product from external manufacturing partners
Supports preparations for regulatory interactions including on-site inspections at Contract service providers
Provides detailed analysis, reports, and updates on project progress to management
Ensures our management team is apprised of all developments that may impact CMC regulatory success and provide solutions and risk mitigation strategies to prevent occurrence of these issues
Education, Experience & Skills Requirements
BS or MS in Biochemistry, Cell Biology or related field, PMP certified preferred
8 + years of relevant industry experience required with GMP AAV manufacturing experience at large scale greatly preferred
Successful track record of supporting release of gene therapy drug products for clinical trials
Strong project management experience and administrative management skills
Strong strategic and technical acumen with an ability to anticipate operational issues and proactively recommend mitigations and solutions
Experience supporting analytical assays for gene therapy drug development
A continuous improvement mindset, with prior experience managing performance objectives, monitoring and assessing results, identifying areas for improvement, and implementing solutions
Strong work ethic with a sense of urgency and deep dedication to getting the job done well, on-time, and without error
Strong written and oral communication skills; comfortable interacting and communicating with individuals at all levels of the organization
Meticulous attention to detail and ability to manage and prioritize multiple projects and tasks
Problem solver who can identify issues and implement creative solutions proactively
Experience in a highly dynamic start-up environment is highly preferred
Compensation will be determined based on relevant skills and experience, but we are targeting a Base Salary of $185-200K for this role.
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