Principal, Biologics Analytical Development & Validation

About Us

About the Role

As the Principal, Biologics Analytical Research & Development you will work closely with other members within the CMC organization to help define group strategy to solve complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines.

You will be reporting to the Senior Director of Analytical Development and provide technology development, strategic leadership, scientific 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), serve as a key member of the project team, collaborating with other functional areas to ensure the timely and successful development of pipeline drug candidates. You must have effective organizational, multi-tasking, and communications skills. A track record of delivering impactful solutions to complex problems, and evidence of strong cross-functional collaboration is expected.

This is an exciting opportunity to join a small, clinical-stage biotech company and have a significant impact on our success. This is a unique opportunity for highly visible and first-hand drug development from mid-stage through commercialization as well as early-stage development with new assets. We are building a team who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives.

Key Responsibilities

• Assist in providing leadership and accountability for execution of overarching strategies for developing, optimizing, and qualifying/validating analytical assays to support the release and stability testing of antibody therapeutic candidates.
• Help conceive, implement, manage, and analyze a diverse range of analytical/bioanalytical and biological testing (including measurement of drug concentrations and anti-drug antibodies) for novel, complex biotherapeutic drug candidates in support of nonclinical and clinical development.
• Work with team to ensure thorough CDMO and Contract Laboratory evaluation, selection, and management, including vendor audits, personnel training, and troubleshooting/investigations as needed for transfer of analytical methods for biological large molecules.
• Actively participate in change management, external investigation and identify appropriate CAPA and implementation plan at third party organizations.
• Coordinate and manage network of third-party organizations for study development and execution.
• Support drafting of regulatory filings in collaboration with Program Leadership and Regulatory. Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA).
• Collaborate with other functional areas to ensure the timely and successful development of drug candidates.
• Manage the stability program, interpret, and analyze stability data and trend analysis.
• Ensure compliance with all relevant regulations, guidelines, and standards for analytical assays.
• Evaluate new technologies and approaches to improve assay development and execution.

Experience

• Minimum BS in analytical chemistry/biochemistry or related field, advanced degree highly preferred.
• Demonstrated experience in analysis of biologics (separation methods such as Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX) and Capillary Electrophoresis (CE-SDS, CEIEF) techniques, and ELISA and PCR-based assays).
• Experience with method validation, method transfer, analytical control strategy development, and execution in a GMP environment.
• Experience in complement, cell based, and physico-chemical assays development for therapeutic proteins is a plus.
• Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications.
• Ability to design, direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.
• Experience with GxP compliance requirements and FDA regulatory guidelines as applicable in support of biologics drug development programs.
• Working knowledge of quality systems and regulatory requirements with prior experience in preparing and defending regulatory filings. Working knowledge of stability testing of biologics is a plus.
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
• 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.
• Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA).
• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.