NkartaNkarta is seeking a highly motivated Supervisor, Manufacturing to join our Manufacturing team. They will lead the Manufacturing team in supporting our efforts in an exciting new area of cancer immunotherapy. This position is based out of South San Francisco, CA.
This person will be responsible for managing a team of cell culture manufacturing specialists in a clinical pharmaceutical environment. In this role you will report to the Director of Manufacturing.
Reports to Director Manufacturing
Location South San Francisco
· Lead and direct the safety, quality, and daily production operations for GMP production suite
· Oversee all tasks on the floor as they are carried out and work closely with manufacturing personnel to troubleshoot process and equipment problems.
· Ensure high levels of communication with the team, support resources, and management regarding issue identification and resolution
· Ensure work is completed in compliance with approved SOPs, batch records and controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed.
· Escalate key risks and issues to manufacturing line and senior management team.
· Investigate and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management
· Coordinate with other departments to ensure on time delivery of the production schedule
· Monitor and coach staff to ensure full compliance with GMP and Quality system requirements
· Demonstrate strong technical writing abilities (deviation initiations, SOP creation, etc.).
· Coach, teach, train and develop employees through 1:1 meetings, performance review and management, and career planning activities. Support recruiting, staffing, hiring, onboarding performance management, promotion and discipline of operators as appropriate.
· Oversees and adjusts training programs within the team, ensuring that manufacturing personnel are current on training requirements.
· Acts as qualified trainer for SOPs and procedures in functional area.
· Work closely with Quality Assurance in the resolution of manufacturing deviations/non-conformances, investigations, change controls and troubleshooting of process and equipment problems.
· Lead and oversee the on-time completion of document review (batch record, logbook, SOPs) for completeness, clarity, accuracy to support on-time release of batches with minimal errors
· Complete same-day review of completed batch records and associated suite documentation
· Generate SOPs, batch records, and other quality documents for equipment and procedures used in the manufacture
· Work effectively with cross functional teams comprised of process sciences, development, facilities & engineering, tech ops, quality control, and quality assurance to ensure right-first-time technology transfer.
- Bachelor’s Degree in scientific discipline or diploma with relevant experience
· A minimum of 5-7 years of experience in cGMP biological manufacturing. Cell Therapy manufacturing or other gene therapy experience is highly preferred.
· A minimum of 2-4 years of leadership experience is preferred.
· Advanced experience working with single-use bioreactors, aseptic operations, equipment, and cell culture, is highly preferred.
· Advanced efficiency working in a Biological Safety Cabinet (BSC).
· Demonstrated ability working with incubators, pipettes, and micropipettes, sterile tube welders, sterile tube sealers, and cell counting machines.
· Experience supervising, coaching, mentoring, and developing direct reports.
· Position is expected to spend ~80% of time gowned on the Manufacturing Floor.· Ability to accommodate off-shift work as required by business demand and manager request.
This position requires the ability to occasionally lift and/or move up to 25 pounds. Specific vision abilities for this job include close vision, depth perception, and ability to adjust focus. The common requirements of an office environment (computers, computer screens, workstations, etc.) apply when not working in or around the laboratory environment. Willing and able to travel up to 10% via car and plane a requirement.
Founded in 2015 at the birthplace of biotechnology, our development pipeline of engineered NK cell therapy candidates includes two co-lead clinical programs, NKX101 and NKX019. Clinical trials for 101 are in process; 019 will begin in H2 2021. Nkarta recently announced a collaboration with CRISPR Therapeutics, a world leader in gene-based medicines, for the development and commercialization of up to three new cell therapy candidates and access to clinically validated CRISPR/Cas9 genome engineering.
Complementing our broad research and development capabilities, Nkarta has also built an extensive cell therapy manufacturing operation. We have a 2,700-square foot clinical good manufacturing practice, or cGMP, facility on-site at our primary corporate location in South San Francisco, California. We plan to start in-house manufacturing of NKX019 in 2021 and NKX101 in 2022. We are also currently designing a separate, larger cGMP facility, to supply our anticipated pivotal clinical trial and commercial needs.
Working at Nkarta
· The 130+ team members describe working at Nkarta through some of the following comments. While getting better work-life balance and improving communications between groups in an early stage start up environment are two areas in which we’re working, here are real anonymous comments of why people think Nkarta is a great place to work.
· “People are always open to ideas. This company provides a safe place for its employees (covid testing, etc.)”
· “Exceptionally talented, committed, *kind* & supportive team”
· “The CEO is transparent and honest with expectations for the whole company. There is genuine care amongst the leadership team for their peers and employees. I believe this is unique.”
· “Not to sound corny, but the emphasis on people as a valuable resource is something I recognize doesn't often exist elsewhere, and it's here in ample supply, which is great.”
· “It's the first place that I've worked where the executive team truly values the employees. It's a pretty amazing thing not to hear that employees can be replaced with someone new. Institutional knowledge is understood.”
· “We have a very diverse team with executives that are friendly and accessible.”
· “Smart and dedicated colleagues. Mission to make a difference in patients lives. Empower us with tools needed to succeed. Open and transparent culture. Transparent leadership. Handling of covid and running the company was done very well.”
To learn more about our work at Nkarta and the career opportunities that will drive us forward to serve patients, please visit the company’s website www.nkartatx.com