Vice President of CMC, Regulatory Compliance and Quality Control
jCyte is a pharmaceutical company based in Newport Beach, CA, dedicated to the development of an intravitreal cell therapy platform technology (jCell) for a broad spectrum of retinitis pigmentosa (RP) patients, with applicability to other retinal degenerative conditions for which there are no treatment options and a significant unmet medical need. jCell has orphan drug status with the FDA and EMA and was the first ophthalmology therapy to receive Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA. The Company has completed phase 1/2a and phase 2b studies in its lead indication, RP, and is planning to commence a phase 3 study shortly.
The Vice President of CMC, Regulatory Compliance and Quality Control will report directly to the Chief Executive Officer and will be the strategic and technical lead for all drug product development activities, including manufacturing design, build-out and scale-up, technology transfer, analytical development and quality control, supply of clinical trial materials (CTM) and logistics, CMC regulatory interactions and filings, and drug product (DP) formulation development. In addition, the position will oversee and be chiefly responsible for ensuring the successful transition of the manufacturing process from a clinical to a commercial stage at the designated GMP manufacturing facility, including all required and pertinent validation activities, in a manner that is fully compliant with regulatory standards.
Duties and Responsibilities
Essential duties and responsibilities include the following:
- Support the development, execution, and optimization of the jCell final drug manufacturing process to produce phase 3 clinical trial and commercial supplies.
- Ensure the final locked drug manufacturing process that is used to manufacture our Phase 3 clinical trial supplies at our selected GMP facility is fully optimized and de-risked from a quality and regulatory standpoint.
- Ensure the design and build out of jCyte’s GMP manufacturing facility that will produce commercial product is optimized from a design, quality, and regulatory compliance perspective.
- Oversee the master validation programs/campaigns to ensure full validation of the facility, test methods, and final drug manufacturing process (for the commercial product) to cGMP standards.
- Troubleshoot DP issues and make recommendations to mitigate risk – specifically, ensure that the final locked manufacturing process that produces our phase 3 clinical trial supplies at the selected GMP facility is as de-risked as possible.
- Manage activities and contractual relationships with contract manufacturers and laboratories performing formulation development, process development, technology transfer, and manufacturing.
- Develop and execute audits/inspections of critical suppliers, identify risks and mitigations, collaborate with suppliers in corrective actions, and prepare executive level presentations to communicate status of the supply chain from a regulatory and commercial perspective.
- Lead the internal team by providing guidance and direction for project strategy, goals, budgets, and other operational activities.
- Create a culture of transparency and empowerment including, for example: (A) the ability to stop release of product if it does not meet quality and regulatory requirements, and (B) the independent authority to stop any action that could place the Company at imminent regulatory risk and in direct violation of regulatory requirements.
- Act as the senior technical and executive leader for the Company’s CMC functions, integrating internal and external team members’ activities into the pharmaceutical development plan and presenting plans and progress updates to the Executive Leadership Team and applicable third parties.
- Lead and collaborate with cross-functional project team members to meet operational objectives, quality benchmarks, and CMC goals within the budget and timeline.
- Compile and review relevant DP information and data to author and coordinate applicable CMC sections within regulatory submissions.
- Work closely with regulatory bodies to understand latest best practices to proactively build in safeguards within jCyte’s processes and procedures.
- Lead regulatory CMC filings (as applicable) in BLA, IND, NDA, IMPD, and PAS covering all phases of pre-clinical and clinical development in both the US and ex-US markets, providing thorough knowledge of relevant FDA, EMA, and other applicable agencies’ regulations.
- Work closely with third party CMC project managers, supply chain managers, and drug substance (DS) teams to plan and coordinate manufacturing activities to meet clinical supply projections.
- Collaborate with the clinical team to establish a supply chain for clinical trial materials (CTMs).
- Direct efforts to implement phase-appropriate analytical methods development and validation to ensure contract development and manufacturing organizations (CDMOs) are using systems and processes in compliance with all relevant regulatory standards.
- Through CDMOs, execute plans for the registration and validation of DS and DP, as required by cGMP and FDA regulations.
- Create and communicate a clear vision among direct report peers, effectively aligning resources and motivating teams to achieve goals.
- Review and approve master and executed manufacturing and packaging batch records.
- Direct the writing and reviewing of documents for BLAs, INDs, NDAs, and other regulatory section submissions; represent the Company as the CMC expert before U.S., European and other regulatory authorities.
- Other duties as may be assigned.
The ideal candidate for the role will be an experienced CMC and operational leader, ideally with both clinical and commercial manufacturing experience with cell therapy products, as well as experience in working with regulatory bodies. The candidate will demonstrate strong leadership skills, a relentless and rigorous approach to CMC processes, as well as a genuine patient-centric value system. The candidate will be highly motivated by the prospect of creating a therapy to treat blindness while joining and continuing to build a talented, unified team.
Technical education, background, and experience related to the following activities:
- An advanced degree in Pharmaceutical Science, Chemistry or other relevant field.
- 10+ years relevant CMC/cGMP industry experience with increasing responsibility in a pharmaceutical or biotechnology environment with prior experience leading all manufacturing activities, and any/all associated regulatory and quality programs.
- Substantial experience in managing US and International CDMOs for the manufacture of cGMP APIs and DP.
- Understanding of physical, chemical, and biological properties that impact formulation design and development.
- Substantial experience managing team and projects in clinical development (e.g., phase 1 through phase 3), pre-launch and post-launch (i.e., commercialization), including a solid understanding of all facets and phases of CMC drug development.
- Understanding of DP design, development, and stability requirements for cellular therapy.
- Understanding of analytical test methods required to support pre-formulation, formulation, and stability testing.
- Knowledge of target drug delivery systems for products in ophthalmology is a plus.
- Experience with tissue procurement and prior working knowledge of associated regulations is a plus.
- Experience and capability in the interpretation of DS and DP stability data.
- Substantial experience implementing technical, strategic, and operational plans.
- Organizational skills to track technical activities related to development milestones, batch testing and release, and stability data.
- Proven track record of management of contract manufacturers and contract laboratories.
- Experience with regulatory CMC filings in BLA, IND, NDA, IMPD, and PAS covering all phases of clinical development in both the US and ex-US markets; thorough knowledge of relevant FDA, EMA, and other agencies’ regulations.
- Experience in compiling technical information (e.g., analytical, formulation, stability) and composing regulatory submissions.
- Thorough understanding of DP GMPs and cGMP quality systems.
- Good written and verbal communication skills, as well as exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators).
- Proven track record of moving drug candidates from phase 2b development to commercialization.
- Willing to travel 25-40% of time.
Qualified candidates should forward their resumes to firstname.lastname@example.org.
jCyte is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.