Senior Manager, Biologics Analytical Research and Development

Role Summary

Senior Manager, Biologics Analytical Research & Development located remotely, reporting to the Senior Director of Analytical Development. Leads strategic and technical efforts in protein biologics method development, optimization, and qualification/validation, and collaborates with CDMOs/CTLs and internal stakeholders to support mid-stage through commercialization of biologics drug candidates.

Responsibilities

• Collaborate with the CMC organization to define strategies solving complex analytical problems at the interface of biology, chemistry, and lab informatics.
• Support clinical drug substance and drug product stability studies at contract laboratories; monitor stability testing and maintain a up-to-date stability database.
• Provide technology development, strategic leadership, and technical expertise in protein biologics method development, optimization, and qualification/validation.
• Build and manage collaborations with external CDMOs and CTLs and work cross-functionally with internal stakeholders to ensure timely development of pipeline drug candidates.
• Assist the supervisor in documentation review and ensure timely data review and regulatory-aligned documentation control related to stability activities.
• Monitor KPIs for stability programs and third-party oversight; support drafting of regulatory filings and internal technical reports.
• Ensure compliance with GMP, FDA, ICH, and EMEA guidelines for stability and analytical assays.

Qualifications

• Required: BS in analytical chemistry/biochemistry or related field with 5+ years of relevant experience; advanced degree highly preferred.
• Required: Demonstrated experience in analysis of biologics (SEC, IEX, CE-SDS/CE-IEF), PCR, cell-based potency assays, and ELISA-based assays.
• Preferred: Experience with analytical method development for fusion proteins/bi-specific antibodies.
• Required: Experience with method validation, method transfer, analytical control strategy development, and GMP environment support for biologics drug development.
• Required: Strong knowledge of analytical methodologies, QbD/DOE principles, and data analysis for setting specifications.
• Required: Ability to design and direct development/qualification of release, characterization, and stability assays for clinical drug substance/product testing and development.
• Preferred: Working knowledge of LIMS, Veeva, SAS and/or JMP.
• Required: Working knowledge of quality systems, GMP, FDA/ICH/EMEA guidelines for stability in biologics.
• Required: Strong communication and collaborative skills; ability to work independently and cross-functionally; ability to meet program deadlines.
• Required: Ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Skills

• Analytical assay development and validation
• Biologics analytical techniques (SEC, IEX, CE-SDS/IEF, ELISA)
• Method transfer and GMP compliance
• Quality systems and regulatory knowledge (FDA/ICH/EMEA)
• Data analysis, statistics, and DOE/QbD principles
• Cross-functional collaboration and vendor management

Education

• BS in analytical chemistry/biochemistry or related field; advanced degree highly preferred

Additional Requirements

• Remote work eligibility; willingness to collaborate with external CDMOs and CTLs as part of the role