Team Lead, Molecular Biology

Job Description

Located at our large molecule headquarters in RTP, North Carolina, the Team Leader position will be responsible for development and management of the molecular biology team supporting Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) assays. This position is a team member in the Large Molecule & Advance Therapy Medicinal Products Services in a Good Manufacturing Practices (GMP) laboratory environment.

Critical Performance Areas

• Lead a team of scientists and analysts in the Molecular Biology team.
• Schedule and coordinate laboratory tasks daily.
• Strong knowledge of method development, qualification, validation, and method transfers for PCR and NGS assays according to GMP requirements.
• Perform data review, handle critical GMP cases, and troubleshoot assays as needed.
• Handle multiple projects at the same time and ensure on-time testing and delivery of analytical results to clients.
• Communicate effectively with clients and act as point of contact for providing project updates.

Essential Job Functions

• Responsible for training, development and performance evaluation of the team.
• Ensure compliance with GMP regulatory requirements and SOPs.
• Main point of contact for customer audits and inspections by authorities.
• Review and approve lab notebooks, draft and review protocols and reports.
• Investigate under GMP for deviation, non-conformity, OOS, change controls and other quality events.
• Help with creation of proposals for analysis.
• Contribute to process improvements for effective and efficient workflows in the lab.
• Supervise maintaining inventory, ordering of laboratory supplies and instruments maintenance.
• Work collaboratively with cross-functional teams.

Requirements

• M.S. or Ph.D. in Life Sciences with 7+ years relevant experience, or B.A./B.S. with 12+ years relevant experience.
• Management experience.
• Client management and project management experience.
• Experience working in GMP or GLP environment.
• Strong experience in method development, qualification and validation of qPCR, ddPCR, NGS assays and other emerging technologies.

Other Desired Skills/Abilities

• Excellent organizational skills, ability to work independently and collaboratively in a team environment.
• Strong written and verbal communication skills.

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