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Manager, QC Lab Support

Society for Conservation Biology

Holly Springs (NC)

On-site

USD 80,000 - 110,000

Full time

30+ days ago

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Job summary

A leading company in biopharmaceutical manufacturing seeks a Quality Control Lab Support leader in Holly Springs, NC. This role involves overseeing quality control processes, managing staff, and ensuring compliance in a dynamic environment. Candidates should have extensive experience in GMP and strong leadership skills to drive continuous improvement.

Qualifications

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

Responsibilities

  • Lead all aspects of QC Lab Support including change controls and investigations.
  • Drive Quality Control KPIs and oversee training for QC Lab Support staff.
  • Manage QC systems and communicate effectively with clients.

Skills

Leadership
Quality Control
Analytical Methods
Microbiology
Data Analysis

Education

Bachelor's degree in Chemistry, Microbiology, Biological Sciences, Engineering
Master's degree in the same fields
Ph.D. in the same fields

Tools

JMP software

Job description

View more categories | View less categories | Sector: Consultancy/Private Sector | Field: Conservation Science | Discipline: Energy | Salary Type: Salary | Employment Type: Full-time

FUJIFILM Diosynth Biotechnologies is constructing a state-of-the-art bioproduction facility in Holly Springs, North Carolina. By the end of 2025, we will inaugurate North America's largest end-to-end CDMO biopharmaceutical manufacturing plant, providing drug substance production, fill-finish, and packaging services under one roof.

We seek passionate, mission-driven individuals to help us realize this innovative vision and contribute to delivering new vaccines, cures, or therapies. Our dynamic work environment fosters a culture we call 'Genki,' designed to energize your purpose and drive. Are you ready to shape the future of medicine? Join us in transforming healthcare!

Holly Springs offers a warm community atmosphere with close proximity to Raleigh's vibrant tech scene, providing the perfect blend of community and opportunity.

What You Will Do
  1. Lead all aspects of QC Lab Support, including change controls, investigations, CAPAs, and data review.
  2. Develop goals and strategies for QC Lab Support aligned with production schedules.
  3. Drive Quality Control KPIs to support quality and continuous improvement, escalating issues as necessary.
  4. Oversee training and development for QC Lab Support staff.
  5. Manage QC systems and business processes.
  6. Communicate effectively with clients and partners regarding QC deliverables and commitments.
  7. Lead inspection discussions and ensure area readiness.
  8. Coordinate with other FDB sites on QC topics.
  9. Manage and develop direct reports within the Lab Support team.
  10. Administer policies affecting employees, such as time off and shift work.
  11. Complete administrative tasks like timecard approvals and expense reports.
  12. Coach and mentor staff to foster professional growth.
  13. Participate in recruitment and retention efforts.
  14. Address performance issues and employee concerns, partnering with HR as needed.
  15. Perform additional duties as assigned.
Minimum Requirements
  • Bachelor's degree in Chemistry, Microbiology, Biological Sciences, Engineering, or related field with 7+ years of experience, or
  • Master's degree in the same fields with 5+ years of experience, or
  • Ph.D. with 3+ years of experience.

Plus:

  • 2-5 years of people management experience.
  • Experience working in a regulated GMP environment.
  • Experience managing and developing teams.
  • Extensive experience with analytical and/or microbiology methods.
Preferred Requirements
  • Over 5 years of GMP experience.
  • Experience in contract manufacturing or testing organizations.
  • Knowledge of statistical experimental design and data analysis using JMP software.
Physical and Work Environment
  • Ability to discern audible cues.
  • Prolonged standing and sitting (up to 240 minutes each).
  • Repetitive motions involving wrists, hands, and fingers.
  • Ability to move objects up to 10 pounds.
  • Ability to bend, push, pull, reach, and twist.
  • Work in small or enclosed spaces.
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