Manager, QC Chemistry

2 days ago


Holly Springs, Georgia, United States FUJIFILM Corporation Full time
Job Title: Manager, QC Chemistry

At FUJIFILM Diosynth Biotechnologies, we are seeking a highly skilled and experienced Manager, QC Chemistry to join our team. As a key member of our Quality Control department, you will be responsible for ensuring the quality and integrity of our products.

Key Responsibilities:
  • Manage the daily activities of the QC Chemistry team to support drug substance and drug product manufacturing processes.
  • Ensure overall performance of the QC Chemistry team according to key performance indicators (KPIs), including turn-around-times for testing and approval.
  • Oversee and manage laboratory exceptions and investigations, and ensure timely closure of cGMP KPI deliverables within the group.
  • Author procedures, documents, and reports to support the QC Chemistry team and tech transfer activities.
  • Represent the QC Chemistry team during internal, customer, and regulatory audits.
Requirements:
  • Bachelor's degree with 8+ years of experience in a GMP environment, or Master's degree with 6+ years of experience, or Ph.D. with 4+ years of experience.
  • 5+ years of experience with analytical testing, preferably raw material testing and release.
  • Previous QC Chemistry management experience.
Preferred Requirements:
  • Master's degree or Ph.D. in Chemistry, Microbiology, Biological Sciences, or related science degree with 6+ years of GMP experience.
  • Previous experience with analytical testing, preferably raw material testing and release in the biopharmaceutical industry.
  • Experience with Microsoft Office, Smartsheet, and laboratory LIMS and ERP systems.
Working Conditions & Physical Requirements:
  • Ability to stand for prolonged periods of time up to 120 minutes.
  • Ability to sit for prolonged periods of time up to 240 minutes.
  • Ability to conduct activities using repetitive motions that include writs, hands, and/or fingers.
  • Ability to operate machinery and/or power tools.
  • Ability to conduct work that includes moving objects up to 33 pounds.
  • Ability to bend, push, or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.
  • Ability to work in environments between -20 and -70 C for a few minutes with appropriate PPE.
  • Will work in heights greater than 4 feet.

FUJIFILM Diosynth Biotechnologies is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class. If an accommodation to the application process is needed, please email FDBN.



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