Senior Consultant, CMC Development and Manufacturing

About the position

GenEdit is a rapidly-growing, early-stage company that is developing a proprietary and novel delivery platform with the potential to transform genetic medicine. Our interdisciplinary team works together across chemistry, payload design, formulation, and screening and preclinical groups to develop the next generation of gene therapies. GenEdit fosters an exciting and dynamic environment where we value impactful data and creative solutions to accelerate our progression from a platform technology to a pipeline of therapeutic candidates. We are seeking talented and motivated individuals to join our team and are expanding across all functions within the organization. Join us in South San Francisco, CA, to be at the forefront of the future of gene therapy. Senior Consultant, CMC Development and Manufacturing GenEdit is looking for an individual who will provide technical and organizational leadership and work closely with cross-functional stakeholders to ensure CMC activities are executed seamlessly and in alignment with the integrated product development plan and program timelines. The individual will lead the management of manufacturing of established drug substances and drug products for late-phase clinical trials and the development of new products. The individual will also contribute to the overall CMC strategy, planning, and execution; provide regulatory documentation for all phases of clinical trials and commercialization; and play a role in CDMO management for other CMC areas including analytical and drug product.

Responsibilities

• Key polymer synthesis and development and manufacturing operations to maintain and advance company pipeline.
• Manage and maintain project timelines for CMC activities in support of early and late-phase clinical trials, ensuring strategy and roadmaps align with and feed into company goals and project timelines.
• Manage in-house CMC personnel and external subject matter experts.
• Lead CDMO and other vendor identification, assessment, qualification, and management with adequate risk assessment.
• Manage tech transfer, process familiarization, and manufacturing at CDMOs to ensure timely delivery of GMP drug substance and drug product.
• Contract and Quality Agreement negotiation.
• Develop and carry-out a QBD approach to identify CPPs in support of CQAs for efficacy and safety of drug substance.
• Author/review/approve the relevant CMC sections to enable global regulatory filings.
• Generate, review, and/or approve study protocols, development reports, and manufacturing batch records.
• Manage developmental stage-appropriate analytical activities.
• Communicate CMC strategy and project status to key stakeholders cross-functionally and assist in driving decision-making.
• Collaborate with cross-functional teams (clinical development, clinical operations, regulatory affairs, quality, IP) to ensure CMC and program goals are met.

Requirements

• PhD in polymer chemistry or polymer science and engineering with industry experience in synthesis scale-up and downstream processing, ideally in a therapeutic drug context.
• 10+ years in industry CMC; 3+ years of experience as CMC team leader, managing team members and projects.
• Proven success in vendor management, specifically CDMOs, with track record of negotiating contracts and completion of projects on time and within budget.
• Successful management of CDMO to manufacture GMP product for late-phase clinical trials is a requirement.
• Thorough understanding and working experience in drug substance development and manufacturing with respect to quality by design, GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements. Experience writing CMC section of NDA is a plus.
• Experience with key analytical techniques: NMR, GPC-RI, HPLC, UV-vis, fluorescence spectroscopy, DSC, ITC, MAL-SEC, and other characterization methods.
• Highly motivated scientist with particular attention to detail and the ability to independently plan, design and implement experiments.
• Excellent written, verbal and presentation skills.
• Work authorization in the US is required.