Manufacturing Lead, Downstream Clinical Mfg
Manager: Manager, Manufacturing
Department: Technical Operations - Manufacturing
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. At Sangamo, we are passionate in developing genomic medicines to transform the lives of patients with serious diseases. We transform 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. Sangamo is a company where individuals can flourish, grow and develop their expertise.
We are seeking top talent to join our team. Let’s build a better future together.
Sangamo Therapeutics is seeking a Manufacturing Lead to contribute to the manufacture of gene and cell therapies for clinical trials and future commercial scale. This individual will lead downstream technology transfer activities for gene therapy manufacturing and will be subject matter expert for downstream equipment. This individual will eventually lead daily downstream manufacturing operations and as well as perform upstream gene therapy and cell therapy processes. Decision-making will be required when needed in addition to some troubleshooting of cell culture, equipment, and/or instrumentation. This is a great opportunity for someone who wants to gain management experience, while developing their knowledge and experience with gene and cell therapies. Schedule to be determined based on manufacturing timelines.
- Perform downstream manufacturing processes including but not limited to TFF, UF/DF, column chromatography, viral filtration
- Perform in-process quality testing using analytical instrumentation
- Write, review and revise Quality documents (SOPs, forms, batch records, protocols) as needed
- Perform Quality processes per Sangamo’s Quality Management System (deviations, CAPA, change control)
- Assist with GMP readiness activities including but not limited to equipment/system commissioning and qualification, generation of raw material specifications and some development/comparability studies
- Assist with day-to-day operations in manufacturing plant
- Assist with execution of process planning/scheduling and resourcing of personnel
- Assist with personnel training and recruiting, as needed
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Minimum of Bachelor’s in biology, biochemistry or other relevant life science. Associate’s plus at least 2 years relevant work experience will be considered.
- 3-5 years experience GxP in regulated lab environment
- Experience with purification techniques (TFF, UF/DF, Column Chromatography)
- Experience in aseptic technique and sterile connections
- Experience with buffer preparation at small scale and large scale
- Proven leadership experience in relevant projects
- Excellent communication skills
- Impeccable attention-to-detail
- Great time-management skills and ability to work in a fast-paced start-up environment
- Knowledge and/or experience with AAV and/or cell therapies a plus
- Experience with mammalian cell culture processing in both small (plate, flask) and large scale (bioreactor) a plus
- 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.