Lead, Manufacturing - Drug Product Filling

Manager: Associate Director, Manufacturing
Department: Brisbane Manufacturing 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.
 

JOB SUMMARY:   

Sangamo Therapeutics is seeking a Manufacturing Lead (or Manager) to contribute to the manufacture of gene and cell therapies for clinical trials and potential future commercial scales. This individual will represent Manufacturing on the project team to implement drug product filling capabilities at the Brisbane Site.   They will serve as SME and owner of the filling equipment, procedures, and operations for the Brisbane Manufacturing team. Once completion of start up, the role will transition to the performance of the product filling processes as well as act as on-the-floor lead during filling operations. In-process decision-making will be required in addition to troubleshooting of the filling equipment. This role will also work closely with Process Development and/or outside partners to perform incoming and outgoing technology and process transfers.

ESSENTIAL FUNCTIONS: 

• Perform manufacturing processes including but not limited to drug substance formulation, drug product filling, and freezing operations. Support other manufacturing processes in cell culture upstream operations, and purification downstream operations using column chromatography, viral filtration, and TFF/UFDF.
• Lead tech transfer activities for drug product filling into clinical manufacturing such as training with development staff, performing comparability studies, generating raw material specifications, coordinating and executing shakedown and/or engineering runs
• Author, review and revise:
  • Quality documents (SOPs, forms, batch records, protocols, summary reports). 
  • Validation documents (user requirements, functional requirement, design requirements, commissioning and qualification protocols)
• Perform Quality processes per Sangamo’s Quality Management System (deviations, CAPA, change control)
• Lead routine production (filling) operations in GMP plant
• Assist with execution of process planning/scheduling and resourcing of personnel
• Develop training plans for Manufacturing associates and execute personnel classroom and on-the-job trainings
• Communicate out project plans, start-up/operational readiness updates, and production schedules to site team members, stakeholders, and management.

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

• Minimum of Bachelor’s in biology, biochemistry or other relevant life science.  Equivalent work experience will also be considered
• 3+ years experience GxP in regulated production environment for Lead role.  
  • 6+ years for Manager role with experience leading a team or a function.
• Strong knowledge of biotech manufacturing processes with a focus on drug product formulation and filling operations.
• Experience with end to end upstream, downstream bioprocessing and/or cell therapy manufacturing operations
• Experience with upstream process equipment such as bioreactors (WAVE and XDR) and upstream analytical equipment such as cell culture analyzers is a plus
• Excellent aseptic technique
• Working knowledge of Quality Systems used in GxP environments and Environmental, Health & Safety (EHS) standards
• Proven leadership experience in relevant projects such as leading technology transfers and/or process changes, overseeing complex processes, and/or managing risk assessment teams
• Excellent communication skills such as providing cross-functional project updates, driving multi-department approvals, and informing management of risks, constraints, and delays.
• Impeccable attention-to-detail
• Great time-management skills and ability to work efficiently in a fast-paced start-up environment
• Ability to analyze and resolve problems independently while incorporating feedback from relevant stakeholders.  

OTHER QUALIFICATIONS:

• Rotational weekend work will be required occasionally
• Experience developing / executing media fill activities a plus
• Knowledge and/or experience with AAV and/or cell therapies a plus
• Experience automated filling lines and isolators a plus

Sangamo is an equal opportunity employer
Sangamo is committed to fostering belonging for all employees and embraces diversity, equity, and inclusion in recruiting and hiring.  All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws

Commitment to Safety
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 & booster, you will have an opportunity to request a reasonable accommodation consistent with applicable laws. 

Note to External Recruiters: We do not accept unsolicited resumes from any source other than from the candidates themselves.