Manager - Tech Ops (Lyophilization expert)

Role Summary

The Manager, Technical Operations (Lyophilization) serves as the subject matter expert for lyophilization and sterile drug product manufacturing processes. This role is responsible for the design, optimization, and scale-up of lyophilization cycles, aseptic filling, and formulation processes, supporting products through development, validation, and commercial manufacturing. The Manager leads and supports technology transfer activities, investigates process deviations, applies statistical tools for process understanding, and authors and reviews CMC documentation to ensure cGMP compliance. The role works cross-functionally with internal teams and external contract manufacturing partners under the guidance of the Director, Technical Operations (Drug Product).

Responsibilities

• Technical Expertise: Serves as a single point SME in lyophilization, sterile processing, and scale-up of Drug Products.
• Technical Design: Design and optimize lyophilization cycles, aseptic filling, and formulation processes for Drug Products.
• Documentation: Author/review technical documents (protocols, reports, regulatory filings) for CMC sections, supporting product lifecycle.
• Product Scope: Experience in OSD is desired, but not necessary.
• Process Deviations: Investigate process deviations, perform root cause analysis, and support process validation (IQ/OQ/PQ) in a timely manner.
• Technology Transfer: Lead/support technology transfer of processes to pilot plants and commercial manufacturing sites.
• Data Analysis: Apply statistical methods (DoE, process capabilities, ANCOVA) for data analysis, ensure cGMP/regulatory adherence, and maintain process documentation.
• Project Ownership: Ownership of assigned projects.
• Cross-Functional Collaboration: Work under the guidance of the Director, Technical Operations (Drug Product), collaborating with internal teams and external contract manufacturing partners, including Technical, Analytical, Quality, Production, and Regulatory personnel.

Skills

• Strong analytical and problem-solving skills with ability to interpret complex data and apply DoE and statistical analyses.
• Proficiency in lyophilization cycle development, process modeling, and use of relevant equipment (lyophilizers, aseptic fillers).
• Experience with cGMP practices and regulatory requirements related to CMC documentation.
• Effective communication and cross-functional collaboration abilities.

Education

• Degree in Chemical Engineering, Biotechnology, or related Life Science.

Qualifications

• 8 to 12 years of hands-on lab/manufacturing experience in sterile fill/finish, lyophilization, and scale-up.
• Lyophilization cycle development, process modeling, equipment (lyophilizers, aseptic fillers), statistical analysis, and cGMP.
• Understanding of CMC requirements and regulatory standards.

Additional Requirements

• Travel: 15%-20%