Manager - Tech Ops (Lyophilization expert) - Lake Forest - CorMedix Therapeutics

    CorMedix Therapeutics
    CorMedix Therapeutics Lake Forest

    3 days ago

    Description

    Overview

    Why CorMedix 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 CorMedix Therapeutics. The culture is patient-centered with urgency to solve pressing issues in hospital-based healthcare. CorMedix's greatest asset is our people, with an experienced team that problem-solves and executes with high precision. We are committed to integrity, open communication, innovation, and fostering an inclusive environment that supports growth and meaningful breakthroughs.

    Company Description: CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for prevention and treatment of life-threatening conditions. CorMedix is commercializing DefenCath (taurolidine and heparin) for preventing catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN, REZZAYO, VABOMERE, ORBACTIV, BAXDELA, and KIMYRSA, as well as TOPROL-XL. CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition and Pediatric populations and intends to develop DefenCath as a catheter lock solution for other patient populations. REZZAYO is approved for treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q 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

    • 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%

    EEO Statement

    CorMedix is an equal opportunity employer. The Company is committed to providing a safe, respectful, and professional work environment that is free from all forms of unlawful discrimination, harassment (including sexual harassment), and retaliation, and complies with all applicable laws prohibiting such conduct. CorMedix does not discriminate against any individual on the basis of race, religion, color, national origin, ancestry, sex, marital/civil union/domestic partner status, family or parental status, sexual orientation, age, disability, or any other status protected under applicable federal, state, or local law.


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