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Manager, Manufacturing

JOB SUMMARY:      Sangamo Therapeutics is seeking an experienced and energetic manufacturing leader to head its Brisbane clinical manufacturing facility.  This position will have accountability for all bioprocess production functions as well as being responsible for building the team that will ultimately own and operate the equipment, systems and space.   Initially, the position will serve as a subject matter expert in developing the needed internal business processes such as authoring the manufacturing documentation required for commissioning, qualifying, and operating the process equipment and facility to meet cGMP standards.  The position will work closely with the other Brisbane technical operations user groups and management in support of meeting GMP readiness timelines and goals.       ESSENTIAL FUNCTIONS:   Provide structure and leadership for a newly formed internal clinical manufacturing group Recruit top talent with every hiring opportunity and motivate and develop members of the department to be key leaders 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 in tech transfers of manufacturing process to/from CMOs and process development to ensure robustness and compliance with relevant standards Partner with other operational functions to ensure success of project goals and GMP readiness and compliance. Develop, implement and own a comprehensive yet flexible GMP manufacturing strategy for the site including the supporting policies and procedures. 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, planinvestment in new plant and equipment and oversee the departmental budget and headcount, as well as the plant's capital expenditure budget.  Facilitate a 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, facilities and quality to ensure smooth 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 internal manufacturing organization including new modalities such as cell therapy   EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:  Bachelor's degree in life science or engineering discipline.  Equivalent work experience also considered.  8 plus years minimum in a bioprocessing role with minimum of 3 years' experience managing a GMP manufacturing team.   Direct experience with bioprocess operations such as cell culture, fermentation, chromatography and purification.   Fill / finish experience a plus. 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. Excellent written and verbal communication skills is a must Relevant legal standards and compliance systems 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 withcontract services such as cleaning, calibration, and equipment maintenance providers. Experience in working with electronic systems.   ERP, LIMS, CMMS, MES Proven leadership skills Methodical and organized in delivery of objectives Ability to analyze and resolve problems independently  
Salary Range: NA
Minimum Qualification
8 - 10 years

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