QUALIFICATIONS:

• PhD in Cell and Molecular Biology, Immunology, Biotechnology, Biochemistry, Microbiology or related fields with 6+ years of relevant experience, or Master/Bachelor’s degree with a minimum of 8+ years of relevant industry experience in a cGMP setup.
• Prior experience performing viral genome titre, infectivity, potency, host cell protein, and host cell DNA assays are required.
• Extensive hands-on experience with development of analytical techniques for characterization and analysis of viral vectors is desired, including: Flow cytometry, qPCR, dPCR, ELISA, SDS-PAGE, Western blot, mycoplasma, sterility, endotoxins.
• Experience in the design and optimization of cell-based potency and infectivity assays.
• Must have experience facing regulatory, Client & external cGMP audits.
• Must have the knowledge of contract testing labs management and its certification.
• Strong knowledge of Regulatory and Pharmacopeia requirements for viral vector gene therapy products.
• Experience with processes involved in viral vector GMP manufacturing, characterization and QC release testing.
• A highly motivated team player with an ability to be productive and a willingness to lead and learn in a fluid, fast-paced and environment are essential.
• Excellent organizational and collaborative skills.

Responsible for the operational aspects of all analytical testing within the QC Laboratory.

• Lead, coach and develop QC personnel (analysts and scientists) to ensuring that analytical testing (chemical, physical and microbiological) and data review is performed in a reliable and timely manner to support production operations with adherence to Standard Operating Procedures (SOP).
• Ensure that the quality systems and practices in the laboratory comply with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP) and Quality Management Standards (QMS).
• Develop, optimize, implement analytical methods and working procedures for characterization, release, and stability testing of viral vector gene therapy products.
• Develop the organisation’s quality testing policy in alignment with regulatory standards.
• Lead and perform lab method validation, transfers of analytical methods from other collaborators/clients, protocol harmonization and optimization from R&D to Production.
• Lead development and qualification of new and/or improved assays and characterization of viral vector products using molecular, biophysical, and other analytical assays.
• Conduct, review or approve laboratory investigations and ensure all follow up actions are completed. Make decisions based on scientific and logical reasoning.
• Compile data, generate reports and perform computations using data analysis software, spreadsheets, graphing, and curve fitting software.
• Align with MSAT, Quality and Production teams on phase appropriate analytical methods and strategies for in-process and QC release testing.
• Collaborate with team members to identify and evaluate assay improvements with the goal of optimizing the current rAAV production process.
• Train fellow colleagues on written procedures pertaining to equipment operation, test methods and general laboratory operations.
• Draft and edit lab protocols, standard operating procedures, sampling plans, technical documents, and release testing records for regulatory or tech transfer purposes.
• Ensure real time documentation, maintain data integrity and appropriate traceability as per quality system.