Senior Manager Manufacturing (Contamination Control)
Company: FUJIFILM Holdings America Corporation
Location: Thousand Oaks
Posted on: March 3, 2025
Job Description:
Position OverviewThe work we do at FUJIFILM Diosynth
Biotechnologies (FDB) changes lives, and our united passion for
advancing tomorrow's medicines - our Genki - will always be our
driving force. While working as a Senior Manager Manufacturing
(Contamination Control) with our Thousand Oaks team, you'll be
joining other motivated individuals who fuel one another's passions
and embrace every day as an opportunity. We aim to foster a
collaborative, innovative and rewarding environment, where diverse
perspectives and people come together united by a common purpose
and shared values. We pursue our fullest potential as individual
contributors and team members. We strive to be the employer of
choice and offer a competitive compensation and benefit
package.Company OverviewJoin 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 DescriptionDepartment:
Internal ManufacturingLocation: Thousand OaksReports To: Senior
Director ManufacturingMajor Activities and Responsibilities:
- Lead the Environmental Support Team to ensure adherence to the
production schedule (ensure all required cleanings and sanitization
are performed in accordance with established guidelines or
specifications without negative impact to the production
schedule)
- Ensure training for the Environmental Support Team is in a
constant state of compliance and is aligned to agency
regulations
- Ownership of the site Contamination Control Program. Ensure all
pillars of the Contamination Control Program are in constant
compliance with agency expectations and regulations
- Lead continuous improvement initiatives related to Facility
Sanitization and Contamination Control
- Own deviations, CAPA and Change Control Records as needed to
support Contamination Control related events
- Responsible for direct reports as it pertains to personnel
management, guidelines, training, disciplinary and performance
appraisal
- Build, develop, and retain a diverse and hard-working team in
alignment with operation readiness schedules to ensure successful
implementation of NPIs and transition to GMP operations
- Responsible for the safety and quality culture of the
department and champion continued improvement
- Revise and/or create manufacturing documents as needed in
support of Contamination Control topics
- Collaborate with manufacturing support groups (Quality, MSAT,
Engineering, Supply Chain, and network partners)
- Support and execute the Environmental Support Team strategy and
ensure strategy is aligned with the broader organizational strategy
and deliver continuous improvement
- Lead and support regulatory inspections for areas of
responsibility including evaluating complex compliance issues and
developing playbooks for the inspections
- Deliver against organizational financial commitments
- Active member of the aseptic mentoring program
- Conduct frequent internal audits of sanitization and job safety
analyses
- Support development and execution of studies and protocols
related to environmental controlsBackground Requirements
(Education, Behavioral, Professional & Technical Capabilities
Experience):Qualifications
- 2-4 years of management experience
- 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
experiencePreferred Qualifications
- Leadership experience in a GMP manufacturing environment
- Experience in applying Operational Excellence and Lean
Manufacturing
- Cross-functional work experience in either Process Development,
Quality, or Engineering
- 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 organizationWork 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 a Good Manufacturing Practice (GMP)
facility governed by regulatory agencies with specific requirements
for hygiene and acceptable clothing. The following items are
restricted when accessing the GMP manufacturing area:
- Makeup, fake/artificial nails or hair (e.g., acrylic nails,
fake eyelashes, wigs, hair extensions, etc.)
- Hats
- Hair products (spray, gel, wax)
- Perfume and cologne
- Jewelry (rings, watches, bracelets, fitness bands, necklaces,
and facial/ear piercings, etc.)
- Donning of gowns requires the ability to physically don gowns
while balancing in a cleanroom environmentPhysical Requirements:
- Subject to extended periods of sitting and/or standing, vision
to monitor and moderate noise levels
- Ability to 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 holidaysSalary and Benefits:
- $130,000 to $162,000, depending on experience
- Medical, Dental, and Vision
- Life Insurance
- 401k
- Paid Time OffTo 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.*#LI-OnsiteEEO InformationFujifilm 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).
#J-18808-Ljbffr
Keywords: FUJIFILM Holdings America Corporation, Thousand Oaks , Senior Manager Manufacturing (Contamination Control), Executive , Thousand Oaks, California
Didn't find what you're looking for? Search again!
Loading more jobs...