Manager - Tech Ops (Lyophilization expert)
CorMedix Therapeutics
4 hours ago
Remote friendly (Parsippany, NJ)
United States
$114,000 - $145,000 USD yearly
Operations
Position Summary
- Manager, Technical Operations (Lyophilization) serves as the subject matter expert for lyophilization and sterile drug product manufacturing processes.
- Responsible for design, optimization, and scale-up of lyophilization cycles, aseptic filling, and formulation processes; supports products through development, validation, and commercial manufacturing.
- Leads and supports technology transfer activities; investigates process deviations; applies statistical tools for process understanding; authors/reviews CMC documentation to ensure cGMP compliance.
- Works cross-functionally with internal teams and external contract manufacturing partners under the Director, Technical Operations (Drug Product).
Primary Responsibilities
- Technical Expertise:
- Act as 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.
- OSD experience 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 to pilot plants and commercial manufacturing sites.
- Apply statistical methods (DoE, process capabilities, ANCOVA); ensure cGMP/regulatory adherence; maintain process documentation.
- Own assigned projects.
- Cross-Functional Collaboration:
- Collaborate with internal teams and external contract manufacturing partners (Technical, Analytical, Quality, Production, Regulatory) under Director guidance.
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.
- Experience with lyophilization cycle development, process modeling, equipment (lyophilizers, aseptic fillers), statistical analysis, and cGMP.
- Understanding of CMC requirements and regulatory standards.
Other
- Travel: 15%–20%
Application Instructions
- Consider applying for a role at CorMedix Therapeutics.
- Manager, Technical Operations (Lyophilization) serves as the subject matter expert for lyophilization and sterile drug product manufacturing processes.
- Responsible for design, optimization, and scale-up of lyophilization cycles, aseptic filling, and formulation processes; supports products through development, validation, and commercial manufacturing.
- Leads and supports technology transfer activities; investigates process deviations; applies statistical tools for process understanding; authors/reviews CMC documentation to ensure cGMP compliance.
- Works cross-functionally with internal teams and external contract manufacturing partners under the Director, Technical Operations (Drug Product).
Primary Responsibilities
- Technical Expertise:
- Act as 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.
- OSD experience 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 to pilot plants and commercial manufacturing sites.
- Apply statistical methods (DoE, process capabilities, ANCOVA); ensure cGMP/regulatory adherence; maintain process documentation.
- Own assigned projects.
- Cross-Functional Collaboration:
- Collaborate with internal teams and external contract manufacturing partners (Technical, Analytical, Quality, Production, Regulatory) under Director guidance.
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.
- Experience with lyophilization cycle development, process modeling, equipment (lyophilizers, aseptic fillers), statistical analysis, and cGMP.
- Understanding of CMC requirements and regulatory standards.
Other
- Travel: 15%–20%
Application Instructions
- Consider applying for a role at CorMedix Therapeutics.