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Position Overview:

We are currently seeking an experienced Director/Sr. Director, QC to join Prime’s growing Technical Development and Operations organization. Reporting to VP, Head of Analytical Development and QC Testing, this individual has the overall accountability for the strategy and execution of the Quality Control function to ensure that business needs are met. The Director/Sr. Director, QC will coordinate Phase appropriate assay qualifications and release and stability testing of Prime Editing components, drug substances and drug products with scientists at Prime Medicine in a matrix manner. She/he will manage QC tasks and personnel directly and indirectly, and provide oversight of externally related QC operations at CTLs and CDMOs,

This is a key leadership position where the successful candidate will decide and implement strategies and be involved in day-to-day laboratory activities. The ideal candidate will have extensive experience and expertise in QC functions, in regulatory expectations and submissions, have strong scientific and management skills, and can communicate and collaborate effectively. This role will work closely with analytical development groups, process development groups, and partner seamlessly with Quality and Manufacturing and Supply Chain to advance Prime Medicine’s development pipeline.

Key Responsibilities:

• Lead and actively participate in release testing method selection, qualification, and documentation for the development of prime editing cell and gene therapy products.
• Accountable for and effectively implement strategies for managing critical reagents, reference standards/controls materials, analytical cell banks.
• Manage QC testing, and stability programs, data analysis, data trending, maintain cGMP compliant documentation. Build and maintain analytical datasets (release and stability, analytical validation) for Starting material components, DS and DP so they are readily available to support CMC team needs and all Regulatory filings.
• Manage test method tech-transfer, work with CTL/CDMOs providing appropriate strategy and oversight, troubleshooting, and ensuring technical and timeline requirements are met.
• Work with analytical development scientists and programs leaders to understand scientific and timeline requirements; recommend and implement phase appropriate QC strategies.
• Work with Quality group to ensure data integrity and regulatory compliance.
• Author, review, and approve protocols, SOPs, technical documents, and contribute to the analytical sections of regulatory submissions.
• Provide strategic leadership to further strengthen drug development/delivery platforms with a highly efficient QC organization. Embrace automation and advance for assay operations and data analysis.
• Attract, hire, and develop talented scientists interested in making critical contributions to developing Prime Editor genomic medicines and ensuring the quality of these products for patients.

Qualifications:

• PhD/MS/BS in cell biology, immunology, molecular biology, bioengineering, or related discipline with 10+ (PhD) 15+ (MS) or 20+ (BS) years of relevant experience.
• Extensive experience and proven track record in leading QC functions in Biotech/Pharma environment. Experience in cell and gene therapy is preferred. Demonstrated analytical and critical thinking skills. Scientific knowledge in analytical methodologies commonly used in industry including microbiological methods. Extensive experience in analytical method qualification/validation, stability program management, QC documents writing and management; Proficient in MS Office application suite as well GMP electronic applications such as LIMS.
• Broad working knowledge of global regulations (i.e. ICH guidance, FDA/EMEA GMP regulations, etc.) Experienced in supporting multiple regulatory filings (e.g., INDs, CTA, BLAs, and interactions with US and foreign regulatory agencies for inspections (preferred).
• Experience in tech transfers and working with CTLs and CDMOs.
• Excellent oral and written communication skills, with the ability to influence and engage across all levels of the company and with external stakeholders and organizations; strong interpersonal skills/diplomacy, and negotiation skills.
• Proven track record in scientific and people leadership; strong mentoring skills and developing staff, both direct and indirect.
• Eager to work collaboratively in a fast-paced, dynamic, entrepreneurial, and team-based setting; Ability to manage multiple priorities with aggressive timelines.
• Develops a powerful sense of shared purpose and motivates teams to solve problems in a way that consistently meets or exceeds goals, encouraging innovation, and creating better ways for doing things.
• Embraces the principles of equality, diversity, and inclusion and creates an inclusive and safe environment enabling all employees to contribute to their full potential.