Lead, Cell Therapy Clinical Manufacturing
Department: Technical Operations
Location: Brisbane, CA
Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. Using its deep scientific expertise and proprietary zinc finger genome engineering technology, Sangamo is working to create genomic cures for patients suffering from severe genetic diseases for which today’s medicines can only treat symptoms. At Sangamo, we are passionate about transforming lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow and develop their expertise.
We are seeking top talent to join our mission. Let’s build a better future together.
Sangamo Therapeutics is seeking a Cell Therapy Manufacturing Lead to contribute to the manufacture of gene and cell therapies for clinical trials and future commercial scale. This individual will perform daily cell therapy manufacturing processes as well as act as on-the-floor lead during daily operations. In-process decision-making will be required in addition to troubleshooting of cell culture and/or instrumentation. This role will also work closely with Process Development and/or outside partners to perform incoming and outgoing technology and process transfers.
- Perform cell therapy manufacturing, including but not limited to cell isolation, cell culture thaw, cell culture maintenance and expansion, transfection, and cell sorting (FACS)
- Perform in-process quality testing using analytical instruments
- Perform environmental monitoring in cleanrooms, as needed
- Planning and executing preliminary runs for GMP readiness, such as wet runs, engineering runs and aseptic simulations
- Participate of transfer of processes from Process Development to clinical GMP manufacturing
- Write, review and revise Quality documents (SOPs, forms, batch records) as needed
- Perform Quality processes per Sangamo’s Quality Management System (deviations, CAPA, change control)
- Lead day-to-day operations in GMP plant
- Assist with execution of process planning/scheduling and resourcing of personnel
- Develop training plans for GMP plant operators as well as execute personnel training
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Minimum of Bachelor’s in biology, biochemistry or other relevant life science
- 3+ years experience GxP in regulated lab environment
- Experience with ex-vivo gene modification of primary cells (autologous and/or allogeneic)
- Working knowledge of Quality Systems used in GxP environments and Environmental, Health & Safety (EHS) standards
- Experience with equipment and process validation a plus
- Proven leadership experience in relevant projects such as leading technology transfers and/or process changes, overseeing lengthy and complicated processes, and managing risk assessment teams
- Excellent communication skills such as providing cross-functional project updates, driving multi-department approvals, and informing management of blockers/delays
- Excellent aseptic technique
- Impeccable attention-to-detail
- Great time-management skills and ability to work in a fast-paced start-up environment
- Ability to analyze and resolve problems independently
- Experience with fill finish a plus
Sangamo is an equal opportunity employer
The above reflects management’s definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.
Sangamo requires all U.S. workers to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Sangamo, and it applies regardless of location or classification of role. If you are unable to receive the vaccine, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
Note to External Recruiters: Please understand that we do not accept unsolicited resumes from any source other than from the candidates themselves. Any agency or independent recruiter must have a signed copy of our agency agreement before presenting candidates. Submission of unsolicited resumes without our signed agreement will not create any implied obligation on our part.