Associate Director, Biologics Analytical Development

Job Title: Associate Director, Biologics Analytical DevelopmentJob DescriptionWe 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 senior 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 background 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 EnvironmentThe 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 Manufacturing. The work environment is dynamic and involves managing external development partners, including CDMOs and CROs, to oversee testing and specialized development activities. Job Type & LocationThis is a Permanent position based out of Durham, NC. Pay and BenefitsThe pay range for this position is $165000.00 - $220000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Competitive salary and health benefits, 401k. Opportunities for training and career advancement. Collaborative and inclusive work environment. Access to cutting-edge research and technology. Job Type & LocationThis is a Permanent position based out of Durham, NC. Application DeadlineThis position is anticipated to close on Nov 13, 2026. Workplace TypeThis is a fully onsite position in Durham,NC.About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.