QC Manager

4 weeks ago

Lexington, Kentucky, United States Genezen Full time
Job Summary

The Quality Control (QC) Bioassay and Virology Manager is a critical role within the QC Operations department at Genezen, responsible for overseeing the day-to-day operations of the QC Bioassay and Virology Testing group. This includes cGMP in-process, lot release, stability, and raw material testing, as well as management of quality system elements such as deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), change controls, data integrity, and training in support of Quality Control testing.

Key Responsibilities
  • Maintain a safe, efficient, functional, and compliant cGMP laboratory according to regulatory, site, and corporate guidelines.
  • Oversee day-to-day operations, including cGMP routine/non-routine testing of in-process, drug substance, final product, virus banks, and cell banks following respective procedures.
  • Support/Review/Approve Instrument Equipment/Instrument validation protocols and reports, as well as routine PM/annual OQ.
  • Ensure all QC equipment/instrumentation is maintained in the validated state and associated logbooks compliant.
  • Management of critical reagents, controls, and laboratory supplies in QC Ops possession.
  • Support method validation and analytical technology transfer activities partnered with QC Technical Services and QA.
  • Initiate, review, lead, and/or manage QMS not limited to: Change Controls, Deviations, Out of Specification, Out of Tolerance, and CAPA.
  • Authors and/or reviews complex documentation such as retest/method/critical reagent protocols and reports, investigations, CMC regulatory sections, and SOPs/Forms.
  • Perform and/or support data and quality metric (KPI) trending as required.
  • Support/author risk assessments as required to support QC Operations.
  • Ensure compliance to all necessary regulatory guidelines and support internal and external audits.
  • Identify, lead, and/or support continuous improvements to current processes/procedures accordingly for increased compliance and efficiency.
  • Represent QC at inter-departmental meetings and liaise with cross-functional departments as needed.
  • Ensure staff are trained to meet capacity and business continuity.
  • Provide coaching and development to directs to meet business and respective career goals.
  • Build strong relations and collaboration with cross-functional teams.
Requirements
  • A minimum of a Bachelor's degree in Life Sciences or Engineering.
  • Experience and Skill Requirements: 10-15 years of cGMP QC testing experience within Bioanalytical/Bioassay/Virology with minimum of years of personnel management.
  • Large molecule, gene, or cell therapy technical experience.
  • Cell culture experience (human-derived cell lines) is required.
  • Excellent analytical and problem-solving skills.
  • Thorough understanding of industry and regulatory testing requirements.
  • Must possess excellent communication, organizational, and time management skills.
  • Self-directed with minimal supervision.
  • Ability to work well with diverse groups.
  • Ability to manage multiple activities with challenging timelines.
  • Ability to motivate, mentor, and develop staff.
Benefits
  • Paid vacation days, amount based on tenure.
  • Paid sick time.
  • 9 observed holidays + 1 floating holiday + 1 volunteer day.
  • 401(k) plan with company match up to 6% of salary, vested immediately.
  • Share Appreciation Rights.
  • Choice of several healthcare plans.
  • FSA and HSA programs.
  • Dental & vision care.
  • Employer-paid basic term life/personal accident insurance.
  • Voluntary disability, universal life/personal accident insurance.
  • Accidental Death & Dismemberment (AD&D) Insurance.

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