Director, Analytical Development and Quality Control (Biologics)

Scorpion Therapeutics; Waltham (MA); Hybrid; USD 177,000 - 221,000; Full time

Benefits offered by this job

Benefits package

Job summary

Scorpion Therapeutics is seeking a Director of Analytical Development and Quality Control to lead the strategy and execution of analytical methods for biologics from early research to commercialization. You will oversee cell-based assay development, method transfer and qualification, and support regulatory filings such as IND and BLA.

The role requires collaboration across Process Development, Quality, Regulatory, and Manufacturing teams, ensuring compliance with ICH, FDA, and EMA standards

Qualifications

• Bachelor's in Chemistry, Biochemistry, or related field is required.
• 10+ years in analytical development within biopharma is required.
• Expertise in cell-based assay development is essential.

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.

Skills

cell-based assay development

leadership

analytical development

Education

Bachelor's in Chemistry or Biochemistry or related

10+ years in analytical development in biopharma

Job description

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.