The Manufacturing Manager is a critical leadership position responsible for leading teams to execute clinical and commercial GMP cell therapy manufacturing activities such as media preparation, master cell banks, viral vectors, cell separation, autologous and allogeneic cell therapy. The Manufacturing Manager is accountable in ensuring manufacturing execution is performed in compliance with all required procedures and expectations are always meet, ensuring successful and complaint delivery of cell therapy technologies. This is a full time on site position.
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Job DescriptionThe Manufacturing Manager is a critical leadership position responsible for leading teams to execute clinical and commercial GMP cell therapy manufacturing activities such as media preparation, master cell banks, viral vectors, cell separation, autologous and allogeneic cell therapy. The Manufacturing Manager is accountable in ensuring manufacturing execution is performed in compliance with all required procedures and expectations are always meet, ensuring successful and complaint delivery of cell therapy technologies. This is a full time on site position.
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 expectedAccountable for driving evaluation of day to day floor issues in collaboration with quality and applicable SME’sProvide 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 adherenceAuthor 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 recordsCollaborate with planning function, facilities, supply chain, program management and MSAT team to ensure on time execution of production plan commitmentsEnsure manufacturing lots conforms to applicable quality standards and batch records are reviewed within established timeframeCollaborate with Program Management and MSAT team to assist in tech transfer, scale up and transition activitiesPartner 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 neededProvide daily production updates at Work Center Team meetings, clients representatives and program management team as neededProvide guidance for implementation of continuous improvement efforts within manufacturing areasRepresent the manufacturing department in interactions with FMEA’s, client visits, inspections and audits and cross-functional projects as neededSupport 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 neededProvide suggestions and support implementation of process optimization and efficienciesLead 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; orBachelor of Science (B.Sc.) with 6+ years of applicable biopharma experience; orAssociate degree with 8+ years of applicable biopharma experience; orHigh school diploma with 9+ years of applicable biopharma experience
Preferred Qualifications:
Leadership experience in a GMP manufacturing environmentExperience in applying Operational Excellence and Lean ManufacturingExcellent communication skills, drive, sense of urgency, energy level and problem-solving abilitiesAbility to forge and maintain positive relationships with other functional areasAbility 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 environmentsConsists of frequent complete use, virtual and in person meetings, and interacting with cross functional teamsThe 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 nailsHair products (spray, gel, wax)Perfume and cologneJewelry (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 levelsAbility move about an office environment and to occasionally enter into the manufacturing environmentsOpen to work various shifts as neededRequired to work weekends and holidays
SALARY AND BENEFITS:
$120,000 to $150,000, depending on experienceMedical, 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.
EEO Information
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.
ADA InformationIf 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).
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