Associate Director, Analytical Development (Biologics)

📋 Description

• Lead development, qualification, and transfer of analytical methods for biologics.
• Oversee CDMOs and contract labs.
• Provide technical oversight for methods used in standards, starting materials, release/testing.
• Manage analytical activities at external contract labs, ensuring rigor and quality.
• Develop and implement CMC analytical strategies for each development stage.
• Author and review CMC sections for regulatory submissions (INDs, IMPDs, BLAs, MAAs).

🎯 Requirements

• PhD in analytical chemistry or related with 8+ yrs; or BS/MS with 15+ yrs.
• Experience in analytical development, method validation, transfer, and stability management.
• Strong knowledge of biologics CMC, including complex modalities and cGMP.
• Experience managing external consultants/CMOs/CDMOs with cross-functional alignment.
• Experience supporting biologics/protein therapeutics from early development to clinical.
• Hands-on HPLC/UHPLC/LC-MS incl SEC, RP, IEX; CE-SDS, icIEF.

🎁 Benefits

• Open, flexible, and collaborative work environment.
• Summary of benefits available to all applicants.