Biologics Analytical Development Lead

BioCryst Pharmaceuticals, Inc.; Northern (KY); Hybrid; USD 150,000 - 210,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. seeks an Associate Director of Analytical Development to lead biologics analytical development and release testing, including method development, qualification, and transfers at CDMOs and CTLs.

The role partners with Drug Substance, Drug Product, Quality, and Regulatory Affairs to ensure CQAs, regulatory-ready data, and timely support for clinical and late-stage programs. You will mentor teams, drive risk management, and stay aligned with global regulatory

Qualifications

• PhD in Chemistry/Biochemistry or related field with 8–12 years of analytical development experience in biologics.
• BS/MS with 10–12 years of industry experience in analytical labs supporting biologics development and manufacturing.
• Strong expertise in potency and impurities assays, data interpretation, and lifecycle management methods.
• Experience supporting regulatory submissions and interactions with Quality and Regulatory teams.

Responsibilities

• Provide scientific and operational leadership for analytical development across biologics programs from early development through late stage and commercialization, including external partners.
• Lead analytical strategies for potency, impurities and release assays to support development, clinical supply, late-stage development and readiness for commercialization.
• Drive data-driven decision making to define CQAs, QTPPs, control strategies and characterization packages for regulatory submissions.
• Lead method development, qualification, transfer, and GMP release and stability testing at CDMOs and CTLs.
• Author and review analytical reports, technical summaries, and regulatory documentation to support product development.

Skills

Potency assays

Impurity assays

Life-cycle management methods

Data interpretation

Regulatory submissions experience

External partnership management

Education

PhD in Chemistry/Biochemistry

BS/MS in Chemistry/Biochemistry

Tools

Job description

BioCryst Pharmaceuticals, Inc. seeks an Associate Director of Analytical Development to lead biologics analytical development and release testing, including method development, qualification, and transfers at CDMOs and CTLs.

The role partners with Drug Substance, Drug Product, Quality, and Regulatory Affairs to ensure CQAs, regulatory-ready data, and timely support for clinical and late-stage programs. You will mentor teams, drive risk management, and stay aligned with global regulatory