Sr Mgr Tech Operations Fermentation Chemistry at Melinta Therapeutics LLC

Lake Forest, Illinois, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Apr, 26

Salary

0.0

Posted On

23 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Fermentation Process, Chemical Processing, Process Optimization, Troubleshooting, Scale-Up Operations, cGMP Compliance, Analytical Chemistry, Technical Documentation, Cross-Functional Collaboration, Root Cause Analysis, Statistical Methods, Process Validation, Technology Transfer, Manufacturing Efficiency, Product Quality, Process Robustness

Industry

Biotechnology Research

Description

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. At CorMedix Therapeutics, our greatest asset is our people. We are proud to have a deeply experienced team complemented by some of the brightest emerging talent—individuals who excel at problem-solving and executing with precision. Our passion for the work we do and the way we do it drives us to continually innovate and improve. We are committed to building highly engaged teams rooted in integrity, open communication, and forward-thinking. We believe in fostering an inclusive environment where every employee is empowered to reach their full potential. By providing opportunities to challenge oneself, grow, and contribute to a shared purpose, we create a community dedicated to making a meaningful impact. At CorMedix, we expect everyone to bring their best selves to work. Together, our collective efforts lead to profound breakthroughs that advance our mission and improve lives. 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 [javascript%3Avoid(0)] or www.melinta.com [javascript%3Avoid(0)]. Position Summary The Senior Manager, Technical Operations – Fermentation/Chemistry serves as a subject matter expert in fermentation and chemical manufacturing processes, overseeing products from Master Cell Bank through post-fermentation operations, scale-up, and commercial production. This role leads the design, optimization, and transfer of processes, ensuring robust, safe, and cGMP-compliant operations across internal sites and CDMO partners. The Senior Manager collaborates cross-functionally with Technical, Analytical, Quality, Production, Supply Chain, Project Management, and Regulatory teams, and authors and reviews CMC documentation to support process validation, regulatory filings, and the full product lifecycle. Primary Responsibilities: Technical Expertise: * Serves as a SME in fermentation process from Master Cell Bank to post-fermentation processes with experience of chemical process knowledge. * Designed and optimized fermentation processes for multiple therapeutic products, guiding them from R&D through scale-up and commercial production. Possess extensive knowledge and hands-on experience in both upstream and downstream processing, incorporating cutting-edge technologies to enhance manufacturing efficiency, product quality and ensuring process robustness, safety, and compliance . * Collaborated effectively with CDMOs to evaluate feasibility, scale-up strategies, and transition processes from pilot to full-scale commercial production for fermentation and chemical synthesis. * Proficient in utilizing analytical tools such as HPLC, GC, filtration techniques, and other instrumentation essential for purification, ultrafiltration/diafiltration (UF/DF), and crystallization processes. * Author and review technical documents—including protocols, reports, and regulatory filings—for Chemistry, Manufacturing, and Controls (CMC) sections to support the entire product lifecycle. Skills & Requirements: * Investigate process deviations, conduct thorough root cause analyses, and support timely process validation activities (IQ/OQ/PQ) to ensure compliance and quality. * Lead and support the technology transfer of processes to pilot plants and commercial manufacturing sites globally, ensuring seamless implementation. * Apply statistical methods (e.g., Design of Experiments, process capability analysis, data justification) for data analysis, ensuring adherence to cGMP and regulatory requirements, while maintaining accurate and comprehensive process documentation. * Possess knowledge of analytical chemistry to enhance process understanding and troubleshooting (a plus). * Take responsibility and accountability for assigned projects, ensuring timely delivery and achievement of objectives. * Cross-Functional & Cross-Cultural Collaboration: Work as a team member under the guidance of the Director, Technical Operations (Drug Substance). Collaborate with internal and external stakeholders from teams of: Technical, Analytical, Quality, Production, Supply Chain, Project Management and Regulatory teams. Qualifications: * Advanced Degree in Chemical Engineering, Chemistry, Microbiology, or related Life Sciences, possibly with a Ph.D. * 8 to 10 years of practical laboratory and manufacturing experience in fermentation and chemical processing, demonstrating expertise in process optimization, troubleshooting, and scale-up operations. * Understanding of cGMP, CMC requirements and regulatory standards/filings. EXEMPT/NON-EXEMPT: Exempt % TRAVEL: 10% -15% 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.

Responsibilities

The Senior Manager oversees fermentation and chemical manufacturing processes, ensuring compliance and optimization from Master Cell Bank through commercial production. This role involves collaboration with various teams and authoring technical documents to support the product lifecycle.