Associate Director/Director of CMC Chemistry

Associate Director/Director of CMC Chemistry

Location: South San Francisco, CA

Position: Full-Time

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 Brisbane, CA, to be at the forefront of the future of gene therapy.

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 early/mid-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.

The successful candidate will be a member of the R&D leadership team to plan and execute on company objectives and R&D strategy for all programs. This person must be a strong scientist with a sound track record of technical expertise and organizational leadership, early and late stage CMC, with knowledge of the drug discovery process from exploratory research to IND submission. This person must be able to guide and drive project teams to make decisions and recommendations to the executive team, is a critical and creative problem solver, and comfortable in a dynamic, start-up environment to find solutions to scientific, technical, and resource allocation issues to move programs forward. The ideal candidate will be a team player with excellent communications skills and work collaboratively across all functions within the company and with external partners.

Responsibilities

•Actively interact with chemistry team and CDMOs with expertise in polymer synthesis, helping with establishing development and manufacturing operations to maintain and advance company’s 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.

•Setting up good documentation practice (GDP), quality management system (QMS) and good laboratory practice (GLP) for early stage CMC development. 

•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.

•CMC and regulatory submission (Module 2.3/3.2.P IND and BLA/NDA) for biologic drug products and vaccines: control strategy, manufacturing and release, testing, stability, packaging and labeling, DS/DP/Finished Product packaging shipping and thermal MVP/OQ/PQ, CMO PAI readiness, and CMO evaluate, select, and manage. 

•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.

Education and Qualifications:

•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.

•Experience in drug delivery and device combination product development-CMC-IND/BLA, regulatory submission, audit (GMP, PAI, mock, DD), GMP compliance (21 CFR Part 211/820/4), quality systems, packaging (DS, DP, bottle, form/fill/seal), quality and supply agreement, batch record review & release, CAPA, deviation, change control, investigation, control strategy, risk management (HA, FMEAs), statistical analysis, complaint handling, biocompatibility, process validation (IQ/OQ/PQ).

•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 working with novel drug product (DP) and setting up their qualified analytical methods that required to set final batch release criteria. 

•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

At GenEdit we are always looking to hire the absolute best talent and recognize that diversity in our experiences and backgrounds is what makes us stronger. We hire candidates of any race, color, ancestry, religion, sex, national origin, sexual orientation, gender identity, age, marital or family status, disability, veteran status, and any other status. These differences are what enable us to work towards the future we envision for ourselves, and the world.