Quality Control Lead

CELLVEC PTE. LTD.; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

CELLVEC PTE. LTD. is seeking a Quality Control Leader to oversee analytical testing in the QC Laboratory. The role involves leading personnel, ensuring compliance with regulatory standards, developing analytical methods for viral vector gene therapy products, and optimizing quality testing policies. Ideal candidates should hold a PhD in a relevant field or equivalent experience in a cGMP environment, with expertise in viral assays and strong organizational skills.

Qualifications

• PhD in relevant field with 6+ years or Master/Bachelor’s with 8+ years in a cGMP setup.
• Must have hands-on experience with viral genome assays.
• Strong knowledge of Regulatory and Pharmacopeia requirements.

Responsibilities

• Lead and develop QC personnel to ensure testing is performed correctly.
• Develop and implement analytical methods for viral vector products.
• Ensure compliance with quality systems, GLP, and cGMP standards.

Skills

Flow cytometry

qPCR

dPCR

ELISA

SDS-PAGE

Western blot

Education

PhD in Cell and Molecular Biology or related field

Master/Bachelor’s degree with relevant experience

Job description

Job responsibilities:

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.

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.