QC Manager - Bioassay & Virology - Genezen

JOB SUMMARY

The Quality Control (QC) Bioassay and Virology Manager is responsible for oversight of the day-to-day operations of the QC Bioassay and Virology Testing group within the QC Operations (Ops) department in support of our clinical and commercial AAV-based products.  This includes but is not limited to cGMP in-process, lot release , stability, and raw material testing.  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, as well as audit readiness/support.  Responsible for managing, coaching, and development of a team (4+ analysts) with varied levels of experience. 

ESSENTIAL JOB FUNCTIONS

• Maintain a safe, efficient, functional and compliant cGMP laboratory according to regulatory, site and corporate guidelines.
• Oversee day-to-day operations that include cGMP routine/non-routine testing of in-process, drug substance, final product, virus banks, 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 including.
• 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 with 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.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

• 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 8 – 10 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

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 25 pounds
• Occasionally lift and/or move up to 50 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus
  Communication
• Frequently required to communicate by talking, hearing, using telephone and e-mail