Job Information
Fujifilm Senior Manager Manufacturing (Contamination Control) in Thousand Oaks, California
Overview
The 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 am 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 Overview
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 Description
Senior Manager Manufacturing (Contamination Control)
Summary of Position:
The Sr. Manager Manufacturing (Contamination Control) is a critical leadership position responsible for oversight on the Environmental Support Team and ownership of the Contamination Control Program at the FDBC site. Through the incumbent’s compliance and manufacturing knowledge, they will lead the team as to ensure facility sanitization requirements are consistently adhered to in support of production schedule adherence. Additionally, this position will own the site Contamination Control Program. The incumbent will ensure all pillars of the Contamination Control Program (Aseptic Processing, Facility Sanitization, Environmental Monitoring, Personnel / Material Controls, Pest Control, Facility Controls, etc.) are in constant compliance with agency expectations and regulations.
Department: Internal Manufacturing
Location: Thousand Oaks
Reports To: Senior Director Manufacturing
Major Activities and Responsibilities:
Lead the Environmental Support Team as to ensure adheres to the production schedule (ensure e all required cleanings and sanitization is performed in accordance with established guidelines or specifications without negative impact to the production schedule)
Ensure training for the Environmental Support Team is in 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 responsibilities including evaluating complex compliance issues and developing playbooks for the inspections
Deliver against organizational financial commitments
Active member of the aseptic mentoring program
Conducts frequent internal audits of sanitization and job safety analyses
Support development and execution of studies and protocols related to environmental controls
Background 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 experience
Preferred 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 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 o 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, 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 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 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 holidays
Salary and Benefits:
$130.000 to $162,000, 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.
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 Information
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).
Job Locations US-CA-Thousand Oaks
Posted Date 3 weeks ago (1/8/2025 12:47 PM)
Requisition ID 2024-32887
Category Manufacturing
Company (Portal Searching) FUJIFILM Diosynth Biotechnologies