Senior Manager Manufacturing (Contamination Control)

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.

External US

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 (~~~.) with 4+ years applicable biopharma experience; or

• Bachelor of Science (~~~.) 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

Join us! FDB 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.

FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.

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.

Job Locations US-CA-Thousand Oaks

Posted Date 10 hours ago (1/8/2025 12:47 PM)

Requisition ID 2024-32887

Category Manufacturing

Company (Portal Searching) FUJIFILM Diosynth Biotechnologies