Manager, Quality Control Bioassay

Manager, Quality Control Bioassay

Location: Lexington, 113 Hartwell Ave Education level: Bachelor / Graduate Job category: Quality Operations Target start date: 6/10/2024 Work Location: On-Site Shift: 1st

uni

Qure is dedicated to bringing therapies for unmet medical needs to patients. Each position at uni

Qure is directly or indirectly responsible for improving the lives of patients. This responsibility is part of our day-to-day working life by living up to high quality standards and by recognizing the sense of urgency in areas of high unmet medical need.

Place in the Organization

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.

Key Responsibilities:

• 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.

Other Responsibilities:

• Other duties, as assigned.

Educational and Other 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 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

• Computer literacy (Microsoft, LIMS, SmartQC, MasterControl, TrackWise, Project Plan)