Sr Mgr Tech Operations Fermentation Chemistry

Role Summary

The Senior Manager, Technical Operations – Fermentation/Chemistry serves as a subject matter expert in fermentation and chemical manufacturing processes, overseeing products from Master Cell Bank through post-fermentation operations, scale-up, and commercial production. This role leads the design, optimization, and transfer of processes, ensuring robust, safe, and cGMP-compliant operations across internal sites and CDMO partners. The Senior Manager 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.

Responsibilities

• 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.

Skills

• 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.

Qualifications

• 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.

Education

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

Additional Requirements

• Travel: 10% - 15%