Associate Director, Biologics Analytical Development

Job Title:

Associate Director, Biologics Analytical Development

Job Description

We are seeking an Associate Director of Biologics Analytical Development to provide scientific leadership and strategic direction for analytical sciences across a growing biologics development portfolio. This position will play a key role in establishing analytical strategies, advancing late-stage analytical development, and ensuring robust, phase-appropriate analytical methods and control strategies throughout clinical development and toward commercialization. The role requires deep expertise in biologics analytical development, CMC regulatory knowledge, strategic leadership, and experience managing external development partners.

Responsibilities

+ Establish and evolve analytical strategies supporting multiple biologics development programs.

+ Develop scientific standards, best practices, and analytical governance across development programs.

+ Identify opportunities to strengthen analytical capabilities, technologies, and external partnerships.

+ Provide scientific guidance and mentorship to analytical scientists.

+ Serve as a technical resource for complex analytical challenges and guide teams toward scientifically sound solutions.

+ Provide scientific leadership for analytical lifecycle management including method validation, comparability strategies, specification development, and reference standard strategies.

+ Guide analytical planning for late-stage clinical development, process validation, commercial readiness, and regulatory submissions.

+ Support phase-appropriate product characterization and the continued development of product and process knowledge.

+ Lead or provide technical direction for investigations involving out-of-specification or out-of-trend analytical results.

+ Partner with analytical project leads to establish consistent scientific and analytical approaches across development programs.

+ Collaborate across Cell Line Development, Upstream and Downstream Process Development, Formulation Development, Bioassay, Manufacturing, Quality, Regulatory Affairs, and related technical functions.

+ Provide analytical expertise during technology transfer, process validation, and preparation for commercial readiness.

+ Provide scientific oversight of external analytical laboratories, CROs, and development partners.

+ Lead technical interactions with external partners.

+ Support analytical technology transfers, due diligence activities, and regulatory inspections.

+ Evaluate emerging analytical technologies and recommend implementation where scientifically appropriate.

Essential Skills

+ Strong experience in biologics analytical development and Analytical CMC.

+ Experience advancing biologic products through IND and clinical development.

+ Expertise in analytical lifecycle activities such as method validation, comparability, specification development, reference standards, and analytical control strategies.

+ Experience leading multidisciplinary CMC teams within a matrix organization.

+ Experience managing CDMOs, CROs, external laboratories, or other development partners.

+ Strong understanding of CMC regulatory expectations for biologic products.

+ Demonstrated experience supporting the development of biologic products.

+ Demonstrated experience advancing biologics through IND and clinical development.

+ Experience leading multidisciplinary CMC teams in a matrix environment.

+ Experience managing CDMOs and external development partners.

+ Strong scientific communication, leadership, and project-management capabilities.

Additional

Skills & Qualifications

+ Ph.D. in Chemical Engineering, Biochemical Engineering, Biological Sciences, or a related scientific discipline with 6+ years of pharmaceutical or biotechnology Analytical CMC experience OR B.S. or M.S. with 12+ years of experience.

+ Experience supporting Phase 2 and/or Phase 3 clinical development.

+ Experience supporting commercial readiness and BLA submissions.

+ Experience addressing questions from U.S. or global health authorities.

+

Experience with technology transfer, comparability, process validation, and analytical lifecycle management.

+ Experience supporting multiple concurrent development programs within a biotechnology environment.

Work Environment

The position is based in Durham, NC, and requires onsite work in a full-time, direct hire capacity. The role involves collaboration with cross-functional teams, including Cell Line Development, Process Development, Quality, Regulatory Affairs, and…