The Sr. Manager Quality Control (QC) Microbiology at Fujifilm Diosynth Biotechnologies California (FDBC) requires both leadership, technical, and business expertise. From a leadership perspective, the selected individual will need to lead, develop, and motivate staff. This requires a self-motivated, flexible, and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment. From a technical perspective, the selected individual will directly oversee QC Microbiology activities and deliverables to provide systems and processes to enable QC to complete department objectives. The Sr. Manager is responsible for ownership of FDBC Environmental Monitoring Program, and proactively identifies and implements industry standard methodologies for QC Microbiology. In addition, role model company core values of trust, delighting our customers, Gemba, and Genki.

Join us! FUJIFILM Diosynth Biotechnologies is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large. 

Job Type: Full Time

City: Thousand Oaks (Los Angeles)

Reports to: Sr Director, Quality Control

Travel: Limited Travel (up to 10%).

Physical Requirements: Subject to extended periods of sitting.

Primary Responsibilities:

• Lead and develop a team of individuals in alignment with department’s objectives.
• Manage QC activities relating to new business initiatives, strategic planning, data management, and coordination of QC microbiology deliverables.
• QC Point of Contact for Environmental Monitoring Program at FDBC.
• Manage the Environmental Monitoring Program and Aseptic Gowning Qualification Program, providing oversight in the development and implementation of standards, methods, procedures, and sampling.
• Provide guidance to the continuous improvement of Environmental Monitoring trend analysis, data integrity, assurance practices for lab information and on the floor laboratory oversight support.
• Support cGMP manufacture, testing, and supply of high-quality cell therapy products.
• Develop phase-appropriate QC Microbiology capabilities, business processes, and procedures.
• Coordinate execution of disinfection effectiveness studies.
• Ensure adequate inventory of laboratory media and supplies required to perform testing.
• Oversees and supports team that investigates deviations that occur in Quality Control areas.
• Supports laboratory investigations, OOS, root cause analysis, and corrective action/preventive action implementation
• Review and approve documents required to support QC Microbiology process documents.
• Coordination of strategic and operational activities within QC including project support, coordination, collation of information, reporting, and data analysis.
• Facilitate effective communication across internal departments.
• Works closely with team members to provide effective solutions to support business and quality objectives.
• Defines and analyzes key performance metrics to drive continuous improvement across QC Microbiology.
• Support regulatory inspections/audits.

Qualifications:

Position Requirements:

• Mastery knowledge of aseptic techniques, and aseptic gowning
• Mastery knowledge in analytical or microbiological methods and respective instrumentation
• Mastery knowledge of document management and lifecycle
• Mastery knowledge of quality systems and their interconnections
• Mastery knowledge of how to control, request, receive and/or distribute product/samples
• Mastery knowledge of product testing, data analysis, and reporting
• Advanced knowledge of sampling plan lifecycle and inventory management
• Advanced knowledge of computer systems (e.g., Word, Excel, LIMS)
• Advanced knowledge of executing methods (e.g., casual factor analysis) for qualification, transfers and validation
• Advanced knowledge of regulations and inspection/audit readiness
• Advanced knowledge of QMS (CAPA, deviation, change control, laboratory investigation)
• Experience in smartsheet, statistical analysis, and/or statistical analysis software (i.e., JMP), is a plus.
• Expert understanding in verbal and written communication, customer-service oriented
• Expert understanding in problem solving and critical thinking
• Expert understanding in project management, teamwork & collaboration
• Expert understanding in decision making

Education and Professional Experience:

• 5+ years of team management experience
• Bachelor of Science (B.Sc.) with 10+ years of experience or an equivalent combination of education; or Master of Science (M.Sc.) with 7+ years of experience; or PhD in Science with 5+ years of experience

SALARY AND BENEFITS:

• $150,000 to $175,000, depending on experience
• Medical, Dental and Vision
• Life Insurance
• 401k
• Paid Time Off

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBCHR@fujifilm.com).