Manager - Tech Ops (Lyophilization expert)
About The Position
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).
Requirements
- Degree in Chemical Engineering, Biotechnology, or related Life Science.
- 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, cGMP.
- Understanding of CMC requirements and regulatory standards.
Nice To Haves
- Experience in OSD is desired, but not necessary.
Responsibilities
- Serves as a single point SME in lyophilization, sterile processing, and scale-up of Drug Products.
- Design and optimize lyophilization cycles, aseptic filling, and formulation processes for Drug Products.
- Author/review technical documents (protocols, reports, regulatory filings) for CMC sections, supporting product lifecycle.
- Investigate process deviations, perform root cause analysis, and support process validation (IQ/OQ/PQ) in a timely manner.
- Lead/support technology transfer of processes to pilot plants and commercial manufacturing sites.
- Apply statistical methods (DoE, process capabilities, ANCOVA) for data analysis, ensure cGMP/regulatory adherence, and maintain process documentation.
- Ownership of assigned projects.
- Work under the guidance of the Director, Technical Operations (Drug Product), collaborating with internal CorMedix teams and external contract manufacturing partners, including Technical, Analytical, Quality, Production, and Regulatory personnel.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
101-250 employees
