FUJIFILM

Supervisor Quality Control Bioanalytical

Job Locations US-CA-Thousand Oaks
Posted Date 2 months ago(6/24/2022 2:35 PM)
Requisition ID
2022-20530
Category
Quality Control
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies

Overview

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Supervisor Quality Control will report directly to the Associate Director, Quality Control at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for managing and scheduling Quality Control activities at QC Bioanalytical laboratories including cell culture, in-process, stability and product release testing. They will lead and develop a team of QC Associates/Sr Associates in alignment with department objectives.

External US

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Job Description:

 

The Supervisor Quality Control role manages a team of individuals and activities for Quality Control Bioanalytical laboratories, including in-process, stability, and product release testing.  Position requires both leadership and technical expertise. The candidate must have GMP laboratory and bioassay, cell biology or immunology experience.  The selected individual will need to lead, develop, train, and motivate staff. This requires a self-motivated, detailed oriented, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment.

 

Reports to: Associate Director, Quality Control

 

Location: Thousand Oaks, CA

 

Travel: Up to 10%

 

Primary Responsibilities: 

 

  • Manage and schedule Quality Control activities at Quality Control Bioanalytical laboratories including cell culture, in-process, stability, and product release testing
  • Manage reagent and materials inventory
  • Lead and develop a team of QC Associates/Sr Associates in alignment with department objectives
  • Author, review, and approve laboratory procedures
  • Support cGMP manufacture and supply of high-quality cell therapy products
  • Participate in laboratory investigations including Unexpected Results (UR)/Out of Specification (OOS)
  • Identify and implement corrective/preventive actions
  • Review and assess proposed changes to assays and/or QC equipment via CAPA, Change Control and Work Orders
  • Implement phase-appropriate QC capabilities, business processes, and procedures
  • Maintain current knowledge base of regulations and policies to ensure that the QC function remains in compliance with applicable company requirements and global regulations.

Qualifications:

  • BS in Science with 5+ years of experience or an equivalent combination of education
  • Experience leading projects with history of achieving results and outstanding outcomes.
  • Experience in cGMP cell therapy manufacturing and/or testing facility is a plus.
  • Knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues.
  • Independent decision-making capability and understand impact of decisions critical.
  • Knowledge of and the ability to implement CFR, USP, and ICH requirements is required.
  • Strong communication skills, team player, and proven negotiation skills.
  • Ability to lead, manage and motivate staff.
  • Able to take ownership of a given assignment, proactively consulting other project team members
  • Ability to identify and implement improvement opportunities
  • Role model for company core values of trust, delighting our customers, Gemba, and Genki.

 

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.

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