Manager - Tech Ops; Lyophilization expert

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Full-time Regular, Lake Forest, IL, US

8 days ago Requisition

Salary Range: $ To $ Annually

Why Cor Medix Therapeutics?

If you are interested in joining an entrepreneurial team, focused on bringing life‑saving therapies to market for critical unmet medical needs, consider applying for a role at Cor Medix Therapeutics. The culture at Cor Medix Therapeutics is patient‑centered where we feel a sense of urgency to solve some of the most pressing issues in hospital‑based healthcare.

Cor Medix Therapeutics ’s greatest asset is our people. We have a deeply experienced team and continue to bring on some of the brightest talent that can problem solve and execute with high‑precision. We are passionate about the work we do and how we do it. We believe in building highly engaged teams that exude integrity, open communication, and innovation. We believe in fostering each employee to reach their highest potential by offering an inclusive environment, opportunities to challenge yourself and grow, and a community of purpose.

We expect that everyone here brings their best selves to work and together, our singular efforts culminate into profound and meaningful breakthroughs.

Company

Description:

Cor Medix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life‑threatening conditions and diseases. Cor Medix is commercializing Defen Cath® (taurolidine and heparin) for the prevention of catheter‑related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, Cor Medix is also commercializing a portfolio of anti‑infective products, including MINOCIN® (minocycline), REZZAYO® (rezafungin), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL‑XL® (metoprolol succinate).

Cor Medix has ongoing clinical studies for Defen Cath in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop Defen Cath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT.

Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit:  or  .

Position 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).

Primary Responsibilities:

• Serve as 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 Cor Medix 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.
• Understanding of CMC requirements and regulatory standards.

EXEMPT/NON‑EXEMPT:
Exempt

% TRAVEL : 15%-20%

EEO Statement:

Cor Medix is an equal opportunity employer. The Company is committed