Sr Mgr Tech Operations Fermentation Chemistry

Role Summary

The Senior Manager, Technical Operations – Fermentation/Chemistry leads fermentation and chemical manufacturing activities from Master Cell Bank through post-fermentation operations, scale-up, and commercial production. The role designs, optimizes, and transfers processes to ensure robust, safe, and cGMP-compliant operations across internal sites and CDMO partners. The position collaborates cross-functionally with Technical, Analytical, Quality, Production, Supply Chain, Project Management, and Regulatory teams, and authors and reviews CMC documentation to support process validation, regulatory filings, and the full product lifecycle.

• Serves as a SME in fermentation process from Master Cell Bank to post-fermentation processes with experience of chemical process knowledge.
• Designed and optimized fermentation processes for multiple therapeutic products, guiding them from R&D through scale-up and commercial production. Possess extensive knowledge and hands-on experience in both upstream and downstream processing, incorporating cutting-edge technologies to enhance manufacturing efficiency, product quality and ensuring process robustness, safety, and compliance.
• Collaborated effectively with CDMOs to evaluate feasibility, scale-up strategies, and transition processes from pilot to full-scale commercial production for fermentation and chemical synthesis.
• Proficient in utilizing analytical tools such as HPLC, GC, filtration techniques, and other instrumentation essential for purification, ultrafiltration/diafiltration (UF/DF), and crystallization processes.
• Author and review technical documents—including protocols, reports, and regulatory filings—for Chemistry, Manufacturing, and Controls (CMC) sections to support the entire product lifecycle.

• Investigate process deviations, conduct thorough root cause analyses, and support timely process validation activities (IQ/OQ/PQ) to ensure compliance and quality.
• Lead and support the technology transfer of processes to pilot plants and commercial manufacturing sites globally, ensuring seamless implementation.
• Apply statistical methods (e.g., Design of Experiments, process capability analysis, data justification) for data analysis, ensuring adherence to cGMP and regulatory requirements, while maintaining accurate and comprehensive process documentation.
• Possess knowledge of analytical chemistry to enhance process understanding and troubleshooting (a plus).
• Take responsibility and accountability for assigned projects, ensuring timely delivery and achievement of objectives.
• Cross-Functional & Cross-Cultural
  
  Collaboration:
  
  Work as a team member under the guidance of the Director, Technical Operations (Drug Substance). Collaborate with internal and external stakeholders from teams of:
  Technical, Analytical, Quality, Production, Supply Chain, Project Management and Regulatory teams.

• Advanced Degree in Chemical Engineering, Chemistry, Microbiology, or related Life Sciences, possibly with a Ph.D.
• 8 to 10 years of practical laboratory and manufacturing experience in fermentation and chemical processing, demonstrating expertise in process optimization, troubleshooting, and scale-up operations.
• Understanding of cGMP, CMC requirements and regulatory standards/filings.

• Advanced Degree in Chemical Engineering, Chemistry, Microbiology, or related Life Sciences, possibly with a Ph.D.

• Travel: 10% - 15%