Director / Associate Director of Process Development
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 Director / Associate Director of Process Development will report directly to the Chief Technology Officer (CTO) and will provide strategic scientific and technical support in both the PD lab and GMP manufacturing settings in accordance with jCyte’s CMC strategy. This critical salaried position will conduct and help lead onsite laboratory work at manufacturing sites located in California, with travel (approximately 25-30%) between the different sites. Salary commensurate with experience.
Duties and Responsibilities
- Work collaboratively with other team members (e.g., pre-clinical, clinical, regulatory) on all aspects of drug development to support the development and optimization of the jCell manufacturing process leading to a successful BLA submission.
- Establish and implement aggressive timelines while simultaneously identifying potential risks and critical path activities.
- Identify, develop, and maintain a full listing of third-party contract manufacturers and vendors, including contract analytical laboratories, in close collaboration with the VP, Regulatory Compliance and Quality Control and other internal team members.
- Propose and implement pertinent risk mitigation strategies.
- Serve as a key liaison with internal CMC team, external consultants and other jCyte teams to manufacture cGMP drug product for clinical trials and commercialization.
- Assist in the hiring, training, and supervising of GMP operators.
- Lead the development and writing of key SOPs, protocols, batch record templates, and work to optimize these critical documents over time.
- Ensure that all internal and external CMC activities adhere to jCyte SOPs and all relevant regulations.
- Synthesize, write and present project and IND/BLA-related reports to internal teams, including executive leadership.
- Conduct complex trouble shooting on technical, equipment, software, and process performance issues to ensure that manufacturing processes used to produce Phase 3 clinical trial supplies and commercial drug product are as de-risked as possible to ensure all final drug product manufactured is safe and effective.
- Independently plan, run and/or supervise experiments to evaluate, develop and optimize upstream and downstream cell therapy manufacturing processes. Communicate results and proposals for next steps.
- Conduct critical analysis of processes for improvement and scalability, utilizing background and expertise to establish and optimize new processes for eventual incorporation into clinical and commercial manufacture of jCell.
- Remain current on cGMP best practices and advancements within the industry; implement new methods/third parties/and other innovations as needed for jCell.
- Biology, biomedical engineering, or related field with at least 3-4 years of hands-on laboratory experience working with neural stem cells.
- Demonstrated skill set in mammalian cell culture is essential; specific familiarity with neural progenitor or retinal progenitor cells is preferred.
- Prior experience with cell therapy PD and/or cGMP cell therapy manufacturing, preferably with commercial-related work experience (i.e., bioengineering or process development background with problem solving skills).
- Prior experience with cell therapy large scale process, closed and single use systems.
- Prior experience and exposure to the FDA and EMA CMC-related regulatory filings
- Ability to work in both PD laboratory and GMP laboratory facilities.
- Strong work ethic, self-motivating, with an orientation toward exceptional achievement
- Desire and ability to work well with other team members and management.
- Able to maintain professionalism under pressure and consistently meet or exceed expectations and deadlines.
- Technical report writing experience and ability.
- Strong data analysis, problem-solving, presentation and communication skills.
- Experience with up-to-date data analytic methods; strong statistics background preferred.
- Excellent written and oral communication skills.
- Ability to work independently and perform well in a team setting.
- Willing to travel up to 25-30% of time.
- Desired: Prior hands-on experience working with the LOVO centrifugation system.
- Desired: Experience in developing new processes, scaling processes.
- Desired: Experience performing various biological analysis assays (e.g., flow cytometry, qPCR, ELISA, etc.)
Qualified candidates should forward their resumes to firstname.lastname@example.org.
jCyte is an equal opportunity employer to all, regardless of age, sex, ancestry, color, disability, exercising the right to family care and medical leave, gender, gender expression, gender identity, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, and sexual orientation.