Cmc Bioassay Development Jobs (NOW HIRING)

SUMMARY

• Clinical-stage biotech advancing antibody into Phase 2b
• Senior scientific leader for analytical strategy — control strategy, comparability, validation, characterization through BLA
• Direct ownership, no layers; drive the work with CDMOs and external labs

About the Position

The Associate Director, Analytical Sciences will provide scientific leadership and strategic direction for analytical sciences across the biologics development portfolio. Reporting to the Senior Director, Tech Ops, this individual will establish department-wide analytical strategies, drive late-stage analytical development, and provide technical leadership to ensure robust, phase-appropriate analytical control strategies and analytical methods. The Associate Director will also ensure phase-appropriate characterization of our products to ensure a growing state of knowledge leading all the way to a BLA filing. Working collaboratively with Analytical Project Leads and other functional leaders, the Associate Director will help integrate analytical activities across programs, strengthen technical capabilities, and prepare development programs for late-stage clinical development and eventual commercialization. This position serves as the senior scientific leader for Analytical Sciences and functions as a strategic partner to Analytical Project Leads and other functional experts. The role focuses on advancing analytical capabilities, enabling late-stage development, and ensuring scientific excellence across the portfolio while collaborating with program leaders responsible for day-to-day execution. This full-time, regular position will be located onsite in Durham, NC.

Summary of Key Responsibilities

Functional Leadership

• Establish and evolve the Analytical Sciences strategy to support the company's growing development portfolio.
• Develop best practices, scientific standards, and analytical governance across programs.
• Identify opportunities to strengthen departmental capabilities, technologies, and external partnerships.
• Mentor scientists and contribute to building a high-performing analytical organization.

Technical Leadership

• Provide scientific leadership for analytical lifecycle management, comparability strategies, method validation, specification development, reference standard strategy, and control strategy development.
• Guide analytical planning for late-stage clinical development, process validation, commercial readiness, and regulatory submissions.
• Lead scientific evaluation of complex analytical challenges and recommend strategic solutions.

Cross-Program Collaboration

• Partner with Analytical Project Leads to provide scientific consultation, establish department-wide analytical strategies, and promote consistency of analytical approaches across the development portfolio.
• Collaborate with Cell Line Development, Upstream and Downstream Process Development, Formulation Development, Pilot Plant, Bioassay, Quality, Manufacturing, and Regulatory Affairs to ensure integrated CMC strategies.
• Support portfolio planning by identifying cross-program opportunities, technical risks, and resource needs.
• Support Quality in updating SOPs and procedures to be phase appropriate

External Scientific Leadership

• Provide scientific oversight for external analytical laboratories and CROs.
• Lead technical interactions with external partners and support due diligence, technology transfers, and regulatory inspections.
• Evaluate emerging analytical technologies and recommend implementation where appropriate.
• Lead investigations as necessary for out-of-trend / out-of-specification results

Required Qualifications

We are looking for professionals with the following required skills to achieve our goals:

• Ph.D. in Chemical/Biochemical Engineering or related Biological Sciences with 6+ years of experience in the Pharmaceutical/Biotech analytical CMC industry, or B.S./M.S. in in Chemical/Biochemical Engineering or related Biological Sciences with 12 years of experience in the Pharmaceutical/Biotech industry analytical CMC industry
• Demonstrated experience advancing biologic products through IND and clinical development
• Experience leading multidisciplinary CMC teams in a matrix environment.
• Experience managing CDMOs and external development partners
• Strong understanding of CMC regulatory expectations for biologic products
• Excellent communication, leadership, and project management skills

Preferred Qualifications

• Experience supporting Phase 2/3 development, commercial readiness and BLA submissions
• Experience with addressing regulatory questions from worldwide health authorities
• Experience with technology transfer, comparability, process validation, and lifecycle management
• Experience supporting due diligence and strategic partnerships with CROs as well as providing oversight to these companies
• Experience working in a fast-paced biotechnology environment with multiple concurrent development programs