Senior Manager, Biologics Analytical Research and Development
Dianthus Therapeutics, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Work collaboratively with the CMC organization to solve complex analytical problems.
- Support activities related to clinical drug substance and drug product stability studies.
- Provide technology development, strategic leadership, and technical expertise in methods development.
- Collaborate cross-functionally to ensure timely and successful development of pipeline drug candidates.
- Assist in monitoring contract laboratory stability testing, documentation, timely data review, and maintaining an up-to-date stability database.
Requirements
- BS in analytical chemistry/biochemistry or related field with 5+ years of relevant experience, advanced degree highly preferred.
- Demonstrated experience in analysis of biologics, including Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX), Capillary Electrophoresis (CE-SDS, CEIEF) techniques, PCR, and cell-based potency assays and ELISA based assays.
- Prior experience with analytical method development for fusion proteins/ bi-specific antibodies is a plus.
- Experience with method validation, method transfer, analytical control strategy development, and execution in a GMP environment in support of biologics drug development programs.
- Strong working knowledge of analytical methodologies, Critical Quality Attributes/QbD/DOE principles, and data analysis and statistics for setting specifications.
- Ability to design and direct the development/qualification of release, characterization, and stability assays to support clinical drug substance / drug product testing and product/process development.
- Working knowledge of LIMS, Veeva, SAS and/or JMP is a plus
- Working knowledge of quality systems, GMP, FDA, ICH, and EMEA guidelines for stability, especially in biologics.
- A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines.
- Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
Benefits
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
analytical chemistrybiochemistrySize Exclusion ChromatographyIon Exchange ChromatographyCapillary ElectrophoresisPCRcell-based potency assaysELISAanalytical method developmentmethod validation
Soft skills
collaborationleadershipcommunicationindependenceteamworkproblem-solvingtime managementadaptabilityplanningdocumentation