The Technical Leader for Quality Control will be responsible for overseeing and guiding the technical work performed by a team of analysts in the biopharmaceutical sector. This role will focus on analytical release and stability testing of monoclonal antibodies (mAbs), gene therapy products, for both drug substances and drug products. The ideal candidate will possess a deep technical background, strong leadership skills, and a passion for fostering innovation and excellence within the QC team.

Key Responsibilities:

• Provide expert guidance on analytical methodologies and techniques relevant to mAbs, gene therapy, including but not limited to:
  • Chromatography (e.g., HPLC, SEC, IEX, RP-HPLC)
  • Mass Spectrometry (e.g., LC-MS, MALDI-TOF)
  • Electrophoresis (e.g., SDS-PAGE, capillary electrophoresis)
  • Enzyme-Linked Immunosorbent Assay (ELISA)
  • Nucleotide and protein quantification (e.g., qPCR, UV-Vis spectrophotometry)
  • Cell-based assays (e.g., cytotoxicity assays, cell proliferation assays, and receptor binding assays)
  • Flow cytometry for analyzing cell populations and assessing phenotypic and functional characteristics.
  • Visual inspection techniques for particulate matter and container closure integrity.

• Facilitate training and development for team members, enhancing their technical skills and knowledge in QC practices.
• Collaborate with scientists and cross-functional teams to troubleshoot and optimize analytical techniques.
• Actively monitor method performance metrics, identifying trends and areas for improvement.
• Lead troubleshooting efforts for any analytical issues, employing root cause analysis to determine underlying problems and implementing effective corrective actions.
• Establish and maintain method performance verification protocols to ensure ongoing compliance with regulatory standards.
• Conduct comprehensive reviews of analytical data to assess consistency, accuracy, and reliability across different testing modalities.
• Integrate findings from various assays and methodologies to provide a cohesive evaluation of product quality and performance.
• Ensure that data reviews align with regulatory requirements and industry best practices, supporting informed decision-making.
• Champion data integrity initiatives, ensuring that all analytical data is generated, recorded, and maintained in accordance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete).
• Implement and monitor systems and practices that ensure the reliability and quality of data throughout its lifecycle.
• Identify and implement process improvements within the analytical framework to enhance efficiency and reliability of testing.
• Foster a culture of continuous improvement, encouraging innovation and adoption of best practices within the QC team.
• Conduct regular audits of data management practices, identifying areas for improvement and ensuring compliance with regulatory standards.
• Work closely with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure alignment on analytical requirements and timelines.
• Communicate technical findings and updates to senior management and stakeholders, translating complex data into actionable insights.
• Review and approve analytical data, ensuring accuracy and compliance with regulatory expectations.
• Manage investigations of deviations and out-of-specification results, implementing corrective and preventive actions as needed.
• Stay updated on regulatory changes and industry trends, ensuring the QC team is prepared for inspections and audits.
• Participate in regulatory submissions and provide technical input as required.
• Ensure comprehensive documentation of all analytical procedures and results, maintaining compliance with GMP and GLP standards.
• Prepare and present technical reports and presentations for internal and external stakeholders.

Qualifications:

• Master’s or PhD in a relevant scientific field (e.g., Biochemistry, Biology, Chemistry).
• 8+ years of experience in quality control within the biopharmaceutical industry, with a strong focus on analytical testing.
• Proven expertise in analytical methodologies related to mAbs, gene therapy products, with hands-on experience in relevant analytical techniques.
• Exceptional leadership and interpersonal skills, with a track record of mentoring technical teams.
• Strong problem-solving abilities and a keen attention to detail.