Analytical Science Manager

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 Therapeutic'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 Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases in the United States. CorMedix is focused on selling and marketing products in institutional settings of care in the US and has field based medical and commercial infrastructure deployed in hospitals, clinics and infusion centers. Rezafungin is currently approved for the treatment of candidemia and invasive candidiasis in adults. For more information visit: www.cormedix.com.

Position: Analytical Science Manager

Position Summary: The Analytical Science Manager-Technical Operations provides critical technical expertise to support analytical method related activities for both drug substance and drug products. Reporting directly to the Director, the Analytical Science Manager collaborates closely with cross-functional and external partners to support manufacturing readiness. This role ensures all analytical methods are robust, compliant with global regulatory standards, and optimized for seamless execution in lab.

Primary Responsibilities:

• Lead analytical method transfers and validation activities for drug substance and drug products.
• Author and review GMP documents such as SOPs, protocols, summary reports, and QMS records.
• Partner with Quality Assurance, Regulatory Affairs, and external test sites to support technology transfers, and analytical method validations.
• Support technical investigations for out-of-specification (OOS) results and collaborate with QA to implement corrective actions.
• Serve as department Quality liaison and utilize Veeva eQMS to manage documents, deviations, change controls and quality events.

Skills & Requirements:

• In-depth knowledge of analytical instrumentation (HPLC, GC, LC-MS), and physical characterization techniques (XRPD, DSC).
• Strong troubleshooting capabilities to resolve complex analytical failures and instrument issues.
• Thorough understanding of global regulatory mandates, including ICH guidelines, cGMP regulations, and industry best practices.
• Strong collaboration and communication skills across cross-functional and global teams.
• Good organizational and multi-tasking skills to successfully manage completing projects.

Qualifications:

• Masters in Chemistry, Pharmaceutical Sciences, or related field with 5-10 years of pharmaceutical industry experience.
• Strong expertise in analytical method validation, and global method transfers.
• Excellent technical writing skills and ability to author regulatory documentation as required.
• Hands-on experience with Veeva eQMS is highly preferred

Work Location:

• This role is based in Parsippany, New Jersey or Lake Forest, IL and requires at least 2 days onsite presence at the corporate headquarters on designated in-office days.

Travel Requirements:

• Ability to travel up to 10 % as needed for meetings, conferences, and company events.

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.