Temporary Associate/Sr. Associate, Manufacturing
Manager: Manufacturing Lead, Cell Therapy
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. 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 Manufacturing Associate or Senior Manufacturing Associate to contribute to the manufacture of cell therapies for clinical trials. This individual will perform and support daily cell therapy manufacturing processes as well as equipment commissioning and qualification, as needed. This role will also support gene therapy manufacturing, as needed. This role will support incoming and outgoing technology and process transfers. New personnel will be trained in project specific techniques and procedures. This is an excellent opportunity to develop your career in the cell therapy industry.
- The initial focus area for this position is to support the tech transfer of a cell-based therapeutic manufacturing process into GMP (Grade B) manufacturing.
- Perform aseptic technique for manufacturing processes including but not limited to medium preparation, cell thaw, cell isolation, transfection, cell maintenance, expansion, passage, and cryopreservation.
- Operate and maintain equipment including but not limited to cell washer, cell separator, cell sorter, cell counter, centrifuge, and controlled rate freezer.
- Maintain and manage GMP materials for daily cell therapy process. Assist with GMP material kitting, as needed.
- Contribute to the development, writing, and review of Standard Operating Procedures (SOPs), Batch Records (BRs), and other GMP documentation.
- Support Sangamo’s Quality Management system including but not limited to deviation investigations and risk assessments.
- Collaborate with cross-functional teams i.e., Quality Assurance, Quality Control, Facilities and Process Development.
- Day-to-day operations in GMP plant
- Assist with execution of pilot runs, engineering runs and APSs.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Minimum of Bachelor’s in biology, biochemistry, or other relevant life science
- 0-5 years’ experience GxP in regulated lab environment
- Excellent aseptic technique
- Experience with ex-vivo gene modification of primary cells (autologous and/or allogeneic)
- Woking knowledge of Quality Systems used in GxP environments and Environmental, Health & Safety (EHS) standards.
- Excellent communication skills such as providing cross-functional project updates, driving multi-department approvals, and informing management of blockers/delays.
- 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 aseptic gowning into Grand A/B environments a plus.
- Cell sorting experience a plus.
- Research and/or process development experience in cell therapy a plus.
- Experience as a trainer a plus.
- Experience with equipment and process validation 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.