Manager - Tech Ops (Lyophilization expert)

Job Title – Manager - Tech Ops (Lyophilization expert)

Job Location - Lake Forest, IL – Onsite from day one – Need to be local

Duration -Full Time

Visa  - Any Visa except H1B,CPT,OPT

Mode Of Interview -  Phone/Skype

Note – Need LinkedIn

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).

Primary Responsibilities: Technical Expertise:

• 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.
• Experience in OSD is desired, but not necessary.

Skills & Requirements:

• 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.

Cross-Functional Collaboration:

• 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.

Qualifications:

• 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.

EXEMPT/NON-EXEMPT: Exempt % TRAVEL : 15%-20