Senior Manager, Biologics Analytical Research and Development

About Us

We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.

About the Role

As the Senior Manager, Biologics Analytical Research & Development, you will work collaboratively with the CMC organization to define strategies to solve complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines. You will also support activities related to clinical drug substance and drug product stability studies at various contract laboratories.

You will be reporting to the Senior Director of Analytical Development and providing technology development, strategic leadership, and technical expertise in protein biologics method development, optimization, and qualification/validation. You will work with and build strong collaborations with external contract manufacturing and testing organizations (CDMOs and CTLs), As a key member of the project team, you will collaborate cross-functionally to ensure the timely and successful development of pipeline drug candidates. Responsibilities include working with and building strong collaborations with external CDMOs and CTLs, as well as with internal stakeholders, assisting the supervisor in monitoring contract laboratory stability testing, documentation, timely data review, and maintaining an up-to-date stability database.

This is an exciting opportunity to join a small, clinical-stage biotech company in a highly visible and dynamic role that will support drug development from mid-stage through commercialization. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• 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.

Experience

• Leading and executing strategies to develop, optimize, and qualify/validate analytical assays to support the release and stability testing of antibody-based therapeutic candidates.