Director, Analytical Development and Quality Control (Biologics)

Role

Director of Analytical Development and Quality Control leading strategy and execution of analytical methods for biologics from early research to commercialization.

Responsibilities

• develop and validate cell-based assays
• oversee analytical method transfer and qualification
• support regulatory filings (IND, BLA, MAA)
• ensure compliance with ICH, FDA, EMA standards
• collaborate cross-functionally with Process Development, Quality, Regulatory, and Manufacturing teams

Requirements

• Bachelor's in Chemistry, Biochemistry, or related
• 10+ years in analytical development within biopharma
• expertise in cell-based assay development
• experience with regulatory submissions and validation
• strong leadership and organizational skills

High Value

• biologics
• cell-based assays
• early to late-stage development
• regulatory compliance
• cross-functional collaboration
• biotech environment

Work Setup

competitive compensation with benefits, salary range $176,900–$221,219, flexible location considerations.