Biologics Analytical Development Leader

BioCryst Pharmaceuticals, Inc.; North Carolina; Hybrid; USD 140,000 - 200,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. seeks an Associate Director of Analytical Development to lead analytical development and release testing across biologics, with emphasis on external CDMOs and CTLs.

You will shape potency and impurity strategies, drive quality data interpretation, and support regulatory filings. You will collaborate with Drug Substance, Drug Product, QA and Regulatory Affairs to ensure robust analytical approaches, timely support for clinical and late-stage programs, and mentorship

Qualifications

• PhD or MSc with extensive experience in biologics analytics and regulatory support.
• Experience supporting regulatory submissions and interaction with Quality and Regulatory functions.
• Strong leadership and collaboration across cross-functional teams.

Responsibilities

• Provide scientific and operational leadership for analytical development across biologics programs, primarily with external partners.
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Skills

Biologics analytics

Potency assays

Impurities assays

Analytical development

Regulatory submissions

External partnerships

Leadership

Communication skills

Education

PhD in Chemistry, Biochemistry, or related field

BS/MS with 10-12 years in analytical labs for biologics

Job description

BioCryst Pharmaceuticals, Inc. seeks an Associate Director of Analytical Development to lead analytical development and release testing across biologics, with emphasis on external CDMOs and CTLs.

You will shape potency and impurity strategies, drive quality data interpretation, and support regulatory filings. You will collaborate with Drug Substance, Drug Product, QA and Regulatory Affairs to ensure robust analytical approaches, timely support for clinical and late-stage programs, and mentorship