Manager, QC Lab Support

Fujifilm Manufacturing USA, Inc; Raleigh (NC); On-site; USD 100,000 - 140,000; Full time

Job summary

A leading company in life sciences is looking for a Manager, QC Lab Support to oversee testing for drug substances and products at their state-of-the-art facility in North Carolina. The ideal candidate will have extensive experience in quality control within a regulated environment, and be skilled in team management and data analysis. This role offers an exciting opportunity to contribute to manufacturing innovations in partnership with biopharma companies.

Qualifications

• 7+ years experience with Bachelor's, 5+ with Master's, or 3+ with Ph.D.
• 2-5 years of people management experience.
• Experience in a regulated GMP environment.

Responsibilities

• Lead QC Lab Support activities including change controls and investigations.
• Oversee training and development for QC Lab Support staff.
• Manage QC systems and processes.

Skills

Leadership

Quality Control

GMP compliance

Data analysis

Team management

Education

Bachelor's degree in Chemistry, Microbiology, Biological Sciences, Engineering, or related field

Master's degree

Ph.D.

Tools

JMP software

Job description

Position Overview

The Manager, QC Lab Support is responsible for leading the Lab Support team to ensure compliant and reliable testing for drug substance and drug product. This role applies broad expertise in biopharmaceutical Quality Control, including QC Chemistry, QC Bioassay, and QC Microbiology, promoting operational excellence and continuous improvement.

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO. FUJIFILM Diosynth Biotechnologies is committed to making a difference by manufacturing the next vaccine, cure, or gene therapy in partnership with leading biopharma companies. We are investing over $2 billion in a new manufacturing site in Holly Springs, North Carolina, which will be the largest end-to-end cell culture CDMO in North America, offering comprehensive biopharmaceutical manufacturing solutions.

What You'll Do

• Lead all aspects of QC Lab Support activities, including change controls, investigations, CAPAs, and data review.
• Develop and implement goals and strategies aligned with production schedules.
• Drive KPIs to support quality and continuous improvement, escalating issues as needed.
• Oversee training and development for QC Lab Support staff.
• Manage QC systems and business processes.
• Communicate effectively with clients and partners regarding QC deliverables.
• Lead inspection preparations and responses.
• Coordinate with other FUJIFILM Diosynth sites on QC topics.
• Manage and develop direct reports within the Lab Support team.
• Handle administrative tasks such as time off, shift scheduling, and expense reports.
• Foster professional development through coaching and guidance.
• Participate in recruitment and retention strategies.
• Address performance and employee concerns, partnering with HR as needed.

Minimum Requirements

• Bachelor's degree in Chemistry, Microbiology, Biological Sciences, Engineering, or related field with 7+ years of experience, or
• Master's degree with 5+ years of experience, or
• Ph.D. with 3+ years of experience.
• 2-5 years of people management experience.
• Experience in a regulated GMP environment.
• Experience managing and developing teams.

Preferred Requirements

• Over 5 years of GMP experience.
• Experience in contract manufacturing or testing organizations.
• Knowledge of statistical experimental design and data analysis with JMP software.

Physical and Work Environment

Ability to discern audible cues, stand and sit for prolonged periods, perform repetitive motions, and move objects up to 10 pounds. Work may involve small/enclosed spaces and physical activities like bending, pushing, pulling, reaching, and twisting.

EEO and ADA Statements

Fujifilm is committed to equal opportunity employment and provides reasonable accommodations for applicants with disabilities.