Cape Town: QC Technical Lead posted by Afrigen Biologics & Vaccines

Afrigen is seeking an experienced and technically skilled QC Technical Lead to oversee the successful transfer of analytical methods into and out of the QC laboratories. This strategic role will manage the full lifecycle of method transfers, working closely with R&D, QC lab teams, and external partners to ensure compliant and scientifically sound implementation. While the position has oversight of the QC Analytical, Biochemistry and Cell Culture labs through direct reports, the primary focus is on leading technology transfer initiatives, troubleshooting technical challenges, and ensuring readiness for GMP testing.

Key Responsibilities:

• Lead Internal and External Analytical Method Transfers: Manage the end-to-end process of method transfers both into and out of the QC laboratories, including collaboration with development teams, manufacturing units, and external partners.
• Provide oversight of the QC Analytical, Biochemistry and Cell culture Laboratories: Coordinate activities across both QC labs through direct supervision of lab supervisors and QC specialists, ensuring alignment with organizational goals, compliance, and testing timelines.
• Ensure Laboratory Compliance, Quality, and Data Integrity: Maintain a strong quality culture by overseeing adherence to cGMP, regulatory requirements, and internal quality systems, with a focus on data integrity and audit readiness.
• Drive Continuous Improvement and Technical Excellence: Champion troubleshooting, technical investigations, and process optimization initiatives to enhance lab performance, method robustness, and operational efficiency.
• Manage and Develop Laboratory Staff: Provide mentorship, training, and performance management for lab analysts to support skill development, operational excellence, and team engagement.

Qualifications and Experience:

• N. Diploma or Bachelors Degree in Biochemistry/Chemistry or related field.
• Previous experience with Technology Transfer of analytical methods.
• Proven track record of analytical method validations and implementation.
• Excellent organisation, communication and time management skills.