Manager, Quality Control

Fujifilm Cellular Dynamics, Inc. (FCDI) is recruiting for an additional Quality Control (QC) Manager to support our continued growth. The QC team supports manufacturing efforts that include cell therapy and research material for ocular, cardiac, autoimmune, oncological and neurological diseases. In this critical role we are looking for a self-motivation and organized person who can lead a team of Quality Control professionals. If you aspire to be a critical resource in creating and maintaining a culture of quality, compliance, and innovation, we offer an exceptional and unique opportunity to fully develop your career potential.

FCDI) is a leading developer and manufacturer of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. The Company partners with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine.

Essential Job Requirements

1. Manage QC therapeutics staff including recruiting, onboarding, developing, coaching, and performance management.
2. Develop short-term and long-term goals for team in alignment with project goals and broader organizational goals; monitor progress against goals.
3. Develop and implement protocols and systems designed to support therapeutic product development, shipping and stability studies, raw material, and finished product testing.
4. Write/review/revise SOPs related to QC testing and equipment including QC Plans, System Impact Assessments, User Requirement Specifications, and equipment usage.
5. Liaise with Research and Development and Production to perform technology transfer for finished product and project-specific cell characterization assays.
6. Assist in QC therapeutics testing on finished products.
7. Assist in customer calls and audits.
8. Serve as subject matter expert for QC therapeutic analytical testing completed both in-house and contracted out.
9. Develop training program specific to QC therapeutic products and associated testing techniques.
10. Develop statistical tools to track and trend QC results.
11. Attend meetings, generate/compile quarterly metrics including but not limited to investigations, deviations, and out of specification reports.
12. Author and oversee the documentation of laboratory deviations and investigations. Lead and support CAPA and continuous improvement initiatives.
13. Write capital expenditure justifications for new equipment.
14. Meet with safety team to evaluate current practices and help develop safety plan for QC.
15. All other duties as assigned.

Required Skills/Education 

• Bachelor’s degree in a life science discipline such as but not limited to cell biology, biochemistry, or microbiology
• Ten years of lab experience relevant to Quality Control in a GMP-regulated facility
• Two years of supervisory experience with the demonstrated ability to mentor and lead a team
• Demonstrated proficiency with cell culture, aseptic techniques, flow cytometry, PCR, ELISA rapid sterility, and molecular biology methods.
• Demonstrated organizational; problem solving; decision-making; communication (oral and written); and influencing skills – dealing with diverse stakeholders.
• Demonstrated work ethic, initiative, ability to manage projects and goals, and intellectual curiosity to learn new technical skills.
• Proficiency with MS office suite of products
• Functional proficiency with an eQMS solution
• Ability to travel 5% travel annually
• Able to work at computer for extended periods of time
• Able to wear standard laboratory PPE, work with hazardous materials (e.g., chemicals, electrical equipment, human tissue), and work in laboratory hood for extended periods of time.

EEO/AGENCY NOTES

Fujifilm 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, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local 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.