Biologics Analytical Development Director

BioCryst Pharmaceuticals; North Carolina; On-site; USD 180,000 - 240,000; Full time

Job summary

BioCryst Pharmaceuticals, based in Durham, NC, seeks an Associate Director of Analytical Development to provide scientific and operational leadership for analytical development and release testing of our biologics portfolio. You will oversee method development, qualification and transfer at external CDMOs and CTLs, ensuring robust strategies for potency, impurities, and regulatory readiness.

You will collaborate with Drug Substance, Drug Product, Quality and Regulatory teams to ensure product

Qualifications

• PhD or MS/BS with extensive experience in analytical development for biologics.
• Experience supporting regulatory submissions and interacting with Quality and Regulatory teams.
• Proven ability to manage external partners and deliver results in a fast-paced biotech environment.
• Strong written and verbal communication for technical and regulatory documents.
• Experience with GMP release and stability testing of biologics.

Responsibilities

• Provide scientific and operational leadership for analytical development across biologics programs.
• Lead strategies for potency, impurities and other release assays to support development and commercialization readiness.
• Define CQAs and control strategies, and support regulatory submissions and process changes.
• Oversee method development, qualification, and testing at CDMOs and CTLs for biologics.
• Author and review analytical reports, summaries and regulatory documentation.
• Mentor and lead internal and matrixed teams; drive continuous improvement.
• Maintain relationships with CDMO and CTL partners to manage risk and prioritize work.
• Stay current with CMC regulatory strategies and industry best practices.

Skills

Analytical development

QC

Regulatory submissions

External partner management

Technical writing

Leadership

Mentorship

Education

PhD in Chemistry or Biochemistry

BS/MS with 10–12 years in analytical labs

Job description

BioCryst Pharmaceuticals, based in Durham, NC, seeks an Associate Director of Analytical Development to provide scientific and operational leadership for analytical development and release testing of our biologics portfolio. You will oversee method development, qualification and transfer at external CDMOs and CTLs, ensuring robust strategies for potency, impurities, and regulatory readiness.

You will collaborate with Drug Substance, Drug Product, Quality and Regulatory teams to ensure product