Director / Sr Director, GMP Facilities
Location: Brisbane, CA
This position will have accountability for all GMP supporting functions for utility operations, maintenance management, and calibration/metrology (internal and contracted) resources serving Manufacturing and Quality Control (QC) Labs for Sangamo’s Manufacturing sites. This position is primarily responsible for building and managing the team that owns, operates, and monitors the support systems and equipment for the Brisbane Manufacturing Operations site. This position will also have oversight supportive responsibility for the Valbonne France GMP Facilities Operations and will require close collaboration with Valbonne Site leadership. The position will serve as a subject matter expert (SME) developing the needed internal GMP processes such as calibration and preventative maintenance programs and driving continuous improvement and harmonization where appropriate across multiple cGMP manufacturing sites. The position will work closely with the other Brisbane project user groups and management in support of meeting project timelines and goals.
- Provide overall GMP Facilities guidance for the Brisbane and Valbonne GMP manufacturing sites
- Serve as a SME for all GMP Facilities related design, construction, and operational needs for Brisbane, Valbonne and potentially future sites
- Partner with Site Heads and other operational functions to ensure success of project goals for GMP readiness and compliance
- Collaborate with Corporate Facilities function to ensure efficient use of resources and aligned strategies supporting the building, utilities, and equipment including the use of Computerized Maintenance Management System (CMMS).
- Develop, implement, and own a comprehensive maintenance and facility strategy for the site, and the supporting policies and procedures
- Recruit top talent with every hiring opportunity. Motivate and develop members of the department to be key leaders within the organization
- Actively influence and participate in the site leadership teams and establishing effective cross-functional leadership relationships and presence
- Contribute to the company’s overall growth strategy, develop plant & equipment investment plans, and oversee the departmental budget and headcount, as well as the site’s capital expenditure budget. Plan strategically for potential offsite GMP warehousing capabilities
- Maximize the success rate for production operations by instituting programs to minimize mechanical failure and enhance equipment performance
- Ensure that appropriate training of all engineering and facilities personnel on equipment, process and facility safety procedures is maintained and up-to-date
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Bachelor’s degree in engineering or other related discipline. Master’s degree preferred. Equivalent work experience may also be considered.
- Leadership experience in GxP pharmaceutical and/or biotechnology regulated environment (10+ years for Director or 15+ years for Senior Director)
- Experience in representing as SME and defending GxP systems in audit setting
- Experience leading teams across multiple sites and influencing across multiple functions.
- Highly functional in a fast-paced dynamic company with the ability to prioritize issues under differing pressures and to work collaboratively with cross-functional teams.
- Excellent written and verbal communication skills is a must
- Substantial operational engineering experience
- Advanced knowledge of Quality Assurance (QA) and Environmental, Health & Safety (EHS) standards including performing risk assessments and mitigation implementation
- Demonstrated application of continuous improvement methods such as LEAN, Six Sigma preferred
- Experienced working on all aspects of capital projects, including budgeting, design, construction, validation, start-up and ongoing operations.
- Experience in Central Utilities including, but not limited to: HVAC, WFI, and purified water, compressed air, N2, chilled water, steam, heating hot water, electrical and process waste
- Experience with electronic Building Management Systems (BMS), Process Control Systems (PCS) and alarm management strategies
- Advanced knowledge and application of Asset Lifecycle Management principles (CMMS, Operation, Maintenance, Calibration Procedures, KPI’s)
- Ability to draft and negotiate vendor contracts
- Proven leadership skills
- Exceptional project management skills and able to negotiate issues with practical solution driven tact
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.