Process Development Scientist
jCyte is a Newport Beach based pharmaceutical company dedicated to the development of an intravitreal cell therapy platform technology for a broad spectrum of retinitis pigmentosa (RP) patients, with potential applicability to other retinal conditions for which there is a substantial unmet need.
The Process Development Scientist will report to the CMC team leader and will provide scientific and technical support in both the PD lab and GMP manufacturing settings. This salary position will be hands-on laboratory work at sites located in California during the 2021-2022 timeframe, with travel (approximately 30%) between different geographical locations. Salary commensurate with experience.
Duties and Responsibilities
- Work collaboratively with other team members (pre-clinical, clinical, regulatory, etc.) on all aspects of drug development leading to BLA submission.
- Establish and implement aggressive timelines, identify potential risks and critical path activities, and propose pertinent risk mitigation strategies.
- Act as a liaison with an external consultant team and CMO to manufacture cGMP cell product for clinical trials and commercialization.
- Train and supervise GMP operators.
- Write SOPs, protocols, batch record templates.
- Write project reports and IND/BLA-related reports.
- Present results, both internally and externally.
- Trouble shooting: Conduct complex trouble shooting, e.g., technical, equipment, software, and process performance issues.
- Planning, running and/or supervising experiments to evaluate, develop and optimize upstream and downstream cell therapy manufacturing processes.
- Critical analysis of processes for improvement and scalability, utilizing background and expertise to establish and optimize new processes for eventual incorporation into clinical cell production.
- Independently designs and executes experiments, including data analysis, communication of results and proposals for next steps.
- Obtains and analyzes experimental data.
- Biology, biomedical engineering, or related field with minimum of 3 years of experience with neural stem cells.
- Demonstrated skill set in mammalian cell culture is essential, specific familiarity with neural progenitors or retinal progenitors is preferred.
- Prior experience with cell therapy PD and/or GMP cell manufacturing, preferably with commercial work experience (i.e., bioengineering or process development background with problem solving skills).
- Prior experience with LOVO process.
- Prior experience with cell therapy large scale process, closed and single use systems.
- Ability to work in both PD lab and GMP facilities.
- Must work well with management and other team members.
- Must be able to maintain professionalism under pressure, meet milestone deadlines, work overtime as needed.
- Desirable: Experience in developing new processes, scaling processes.
- Desirable: experience performing various biological analysis assays (e.g., flow cytometry, qPCR, ELISA, etc.)
- Technical report writing
- Data analysis, presentation and communication skills
- A strong data analysis/statistics background
- Good written and oral communication skills; independent work skills; strong work ethic; delegating skills; ability to perform in a team setting
- Willing to travel up to 30% 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.