Job Abstract

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.