Department: Internal Manufacturing
Location: Thousand Oaks, CA
Reports To: Manufacturing Associate Director
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Oversee day to day cell therapy manufacturing operations ensuring supervisors leads their teams as expected
- Accountable for driving evaluation of day to day floor issues in collaboration with quality and applicable SME’s
- Provide guidance to shift supervisors in response to day-to-day issues, compliance, personnel management, shift schedules, aseptic behaviors, safety, inventory management and continuous improvement
- Responsible for development of robust and agile training plan as to ensure the demands of new technologies and processes can be supported without impact to schedule adherence
- Author and or revise manufacturing SOP’s Batch records, work instructions, validation protocols. Lead investigation of quality events including but not limited to; investigation records, CAPA’s and Effectiveness check records
- Collaborate with planning function, facilities, supply chain, program management and MSAT team to ensure on time execution of production plan commitments
- Ensure manufacturing lots conforms to applicable quality standards and batch records are reviewed within established timeframe
- Collaborate with Program Management and MSAT team to assist in tech transfer, scale up and transition activities
- Partner with people department in support of hiring, selection and retention process of manufacturing personnel by supporting interviews, onboarding process, team building and other employee engagement activities as needed
- Provide daily production updates at Work Center Team meetings, clients representatives and program management team as needed
- Provide guidance for implementation of continuous improvement efforts within manufacturing areas
- Represent the manufacturing department in interactions with FMEA’s, client visits, inspections and audits and cross-functional projects as needed
- Support with technical expertise in the development of new processes, techniques and standards.
- Assist facilities, engineering and validation teams in execution of maintenance, calibration and validation activities, as needed
- Provide suggestions and support implementation of process optimization and efficiencies
- Lead by example exhibiting our company values and 9 people fundamentals in day-to-day interactions
BACKGROUND REQUIREMENTS (Education, Behavioral, Professional & Technical Capabilities Experience):
Qualifications:
- 2-4 years’ experience in leading teams
- Master of Science (M.Sc.) with 4+ years applicable biopharma experience; or
- Bachelor of Science (B.Sc.) with 6+ years of applicable biopharma experience; or
- Associate degree with 8+ years of applicable biopharma experience; or
- High school diploma with 9+ years of applicable biopharma experience
Preferred Qualifications:
- Leadership experience in a GMP manufacturing environment
- Experience in applying Operational Excellence and Lean Manufacturing
- Excellent communication skills, drive, sense of urgency, energy level and problem-solving abilities
- Ability to forge and maintain positive relationships with other functional areas
- Ability to effectively develop and mentor staff and positively advance the culture of an organization
WORK ENVIRONMENT:
- Work is generally performed in an office environment with occasional entry into manufacturing environments
- Consists of frequent complete use, virtual and in person meetings, and interacting with cross functional teams
- The Manufacturing Environment is Good Manufacturing Practice (GMP) facility. A GMP facility is governed by regulatory agencies in which there are specific requirements for hygiene and acceptable clothing. The following items are restricted when accessing the GMP manufacturing area:
- Makeup, painted nails
- Hair products (spray, gel, wax)
- Perfume and cologne
- Jewelry (rings, watches, bracelets, fitness bands, necklaces, and facial/ear piercings, etc.)
- Donning of gowns requires ability to physically don gowns while balancing in a cleanroom environment
PHYSICAL REQUIREMENTS:
- Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels
- Ability move about an office environment and to occasionally enter into the manufacturing environments
- Open to work various shifts as needed
- Required to work weekends and holidays
SALARY AND BENEFITS:
- $120,000 to $150,000, 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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