Senior Manager, Manufacturing

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Job description

Manager: Sr. Director, Manufacturing Operations Site Head

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 an experienced and energetic manufacturing leader for our Brisbane clinical manufacturing facility. This position will have accountability for all bioprocess production functions as well as being responsible for leading the team that is accountable for ownership and operation of the process equipment, systems and space. The role will serve as a subject matter expert in the business and technical processes related to the operations of the facility and equipment as well as production specific procedures and documentation to meet cGMP standards and Sangamo's business needs. The position will partner with Sangamo technical operations groups and management in support of meeting GMP capability readiness timelines and production goals.

ESSENTIAL FUNCTIONS:

• Provide structure and leadership for the Brisbane clinical manufacturing group
• Recruit top talent with every hiring opportunity and motivate and develop members of the department to be key leaders/contributors within the organization.
• Serve as a SME for all manufacturing related operational needs for the Brisbane site as well as potentially future sites.
• Serve as a primary stakeholder and potential co leader in tech transfers of manufacturing process to/from CMOs and process development to ensure robustness and compliance with current cGMP standards
• Partner with other operational functions to ensure completion of corporate goals with GMP readiness and compliance in mind.
• Develop, implement and own a comprehensive yet flexible GMP manufacturing strategy for the site including the supporting policies and procedures. Revise and improve as appropriate.
• Actively influence and participate in the site leadership team while establishing effective cross-functional leadership relationships with a collaborative culture.
• Contribute to the company's overall growth strategy, oversee the departmental budget and headcount, as well as the manufacturing operation's capital expenditure budget.
• Facilitate and participate in an efficient yet robust GMP and safety training program that focuses on continuous improvement of processes
• Ensure that appropriate training of all manufacturing personnel on equipment, process and facility safety procedures is maintained and up-to-date.
• Partner with supply chain, GMP warehouse, GMP facilities and quality to ensure smooth operations that supports delivery of clinical product per plan. Ensure material, maintenance, scheduling and other document needs are communicated in a concise and timely manner.
• Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet evolving technologies
• Expands the technical capabilities of the Brisbane manufacturing site including new production modalities as needed

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

• Bachelor's degree in life science or engineering discipline. Equivalent work experience also considered.
• 8 plus years in a bioprocessing role with minimum of 5 years' experience managing a GMP manufacturing team.
• Direct experience with multiple bioprocess unit operations such as cell culture, fermentation, filtrations, chromatography and purification. Drug Product Fill / finish or Cell Therapy experience a plus.
• Proven leadership skills that are flexible to be effective with a diverse and skilled work force
• Demonstrated track record of managing hands-on cGMP manufacturing operations
• Experience working with or selection of single use technology platforms for support, upstream, and downstream bioprocessing operations.
• Working understanding of pharmaceutical supply chain including serialization
• Experience in representing as SME for manufacturing and defending GxP systems in audit setting
• Highly functional in a fast-paced dynamic company with ability to prioritize issues under differing pressures. Methodical and organized in delivery of objectives
• Excellent written and verbal communication skills is a must. Ability to communicate in all directions effectively is a critical skill with tailored content for audiences.
• Familiar with relevant legal standards and compliance systems
• Strong working knowledge of Quality Assurance (QA) and Environmental, Health & Safety (EHS) standards
• Demonstrated application of quality and efficiency improvement methods such as LEAN, Six Sigma
• Experienced working with contract services such as cleaning, calibration, and equipment maintenance providers.
• Experience in working with electronic systems. ERP, LIMS, CMMS, MES
• Ability to analyze and resolve problems independently as well as lead multi disciplinary teams through root cause and corrective action exercises.

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.

COVID-19

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.

If you wish to be considered for the presentation of candidates, please contact us through . Attach your contact information, your area of specialty, and any marketing information you wish to provide. Someone from the Talent Acquisition Department will contact you directly if there is a business need for your services.

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