Manager - Tech Ops (Lyophilization expert)
CorMedix Therapeutics
4 hours ago
On-site
Lake Forest, IL
$114,000 - $145,000 USD yearly
Operations
Position Summary
- Serve as the subject matter expert for lyophilization and sterile drug product manufacturing processes.
- Design, optimize, and scale-up lyophilization cycles, aseptic filling, and formulation processes.
- Support products through development, validation, and commercial manufacturing.
- Lead/support technology transfer activities.
- Investigate process deviations, apply statistical tools for process understanding, and author/review CMC documentation to ensure cGMP compliance.
- Collaborate cross-functionally with internal teams and external contract manufacturing partners under the guidance of the Director, Technical Operations (Drug Product).
Primary Responsibilities
- Single point SME in lyophilization, sterile processing, and scale-up of Drug Products.
- Design and optimize lyophilization cycles, aseptic filling, and formulation processes.
- Author/review technical documents (protocols, reports, regulatory filings) for CMC sections.
- Experience in OSD desired but not necessary.
Skills & Requirements
- Investigate process deviations, perform root cause analysis, and support process validation (IQ/OQ/PQ) timely.
- Lead/support technology transfer to pilot plants and commercial manufacturing sites.
- Apply statistical methods (DoE, process capabilities, ANCOVA) and ensure cGMP/regulatory adherence; maintain process documentation.
- Ownership of assigned projects.
Qualifications
- Degree in Chemical Engineering, Biotechnology, or related Life Science.
- 8–12 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.
Travel
- 15%–20%.
- Serve as the subject matter expert for lyophilization and sterile drug product manufacturing processes.
- Design, optimize, and scale-up lyophilization cycles, aseptic filling, and formulation processes.
- Support products through development, validation, and commercial manufacturing.
- Lead/support technology transfer activities.
- Investigate process deviations, apply statistical tools for process understanding, and author/review CMC documentation to ensure cGMP compliance.
- Collaborate cross-functionally with internal teams and external contract manufacturing partners under the guidance of the Director, Technical Operations (Drug Product).
Primary Responsibilities
- Single point SME in lyophilization, sterile processing, and scale-up of Drug Products.
- Design and optimize lyophilization cycles, aseptic filling, and formulation processes.
- Author/review technical documents (protocols, reports, regulatory filings) for CMC sections.
- Experience in OSD desired but not necessary.
Skills & Requirements
- Investigate process deviations, perform root cause analysis, and support process validation (IQ/OQ/PQ) timely.
- Lead/support technology transfer to pilot plants and commercial manufacturing sites.
- Apply statistical methods (DoE, process capabilities, ANCOVA) and ensure cGMP/regulatory adherence; maintain process documentation.
- Ownership of assigned projects.
Qualifications
- Degree in Chemical Engineering, Biotechnology, or related Life Science.
- 8–12 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.
Travel
- 15%–20%.