Summary
Location
Parsippany-Troy Hills, Lake Forest
Type
full-time
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About this role
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 at CorMedix Therapeutics is patient-centered where we feel a sense of urgency to solve some of the most pressing issues in hospital-based healthcare.
CorMedix 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:
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath® (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, CorMedix 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).
CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop DefenCath 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: www.cormedix.com or www.melinta.com.
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.
Other facts
About Melinta Therapeutics LLC
High touch and big impact are trademarks of Melinta. We are nimble and agile without sacrificing our dedication to adding value everywhere we go.
You see, the people of Melinta are believers. Woven into the fiber of our culture is tenacity, brilliance, resilience, excellence and courage. Nothing can weaken our resolve. We take each responsibility seriously, because when we make a move, it matters.
Watch us as we grow. We are the company of the moment and the enterprise of the future. We’re unparalleled in our ability to meet the unmet needs of our patients, and we do so collaboratively. Because we believe the most diverse teams produce the most meaningful impact.
We can’t wait to make legendary strides. Every step counts.
What you'll do
- The Manager, Technical Operations (Lyophilization) is responsible for the design, optimization, and scale-up of lyophilization cycles and aseptic filling processes. This role also leads technology transfer activities and ensures compliance with cGMP standards.
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