Associate Director, Analytical Sciences – Biologics

Implaion Recruiting

Durham (NC)

On-site

USD 180,000 - 240,000

Full time

6 days ago

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Job summary

Implaion Recruiting seeks an Associate Director of Analytical Sciences to provide scientific leadership across biologics development. This onsite Durham, NC role will define analytical strategies, drive late-stage development, and guide regulatory submissions, partnering with project leads and external labs to advance programs toward a BLA.

The position requires a PhD with 6+ years in pharma/biotech analytical CMC, or a BS/MS with 12+ years, and a proven track record in CMC leadership,

Qualifications

Ph.D. in Chemical/Biochemical Engineering or related Biological Sciences with 6+ years in pharma/biotech analytical CMC.
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.

Responsibilities

Establish and evolve the Analytical Sciences strategy to support the growing development portfolio.
Develop governance, standards, and analytical practices across programs.
Mentor scientists and build a high-performing analytical organization.
Provide lifecycle management, comparability, method validation, and control strategy leadership.
Lead interactions with external laboratories, CROs, and regulatory bodies to ensure robust CMC strategies.