Associate Director, Analytical Development and Quality Control (Small Molecules)

Scorpion Therapeutics; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director of Analytical Development and Quality Control to lead strategy and execution of analytical methods for small‑molecule biopharmaceuticals from early research to commercialization.

Responsibilities include developing and implementing analytical strategies, overseeing method development, validation, transfer and compliance, supporting regulatory submissions, and guiding technology evaluations while collaborating with Process Development,

Qualifications

• Bachelor's in Chemistry, Biochemistry, or related field.
• 8+ years in analytical development within biotech or pharma.
• Strong expertise in solid oral dosage and biologics analytics.
• Experience with method validation, regulatory filings, and compliance.
• Deep knowledge of ICH, FDA, EMA guidelines.
• Excellent leadership and communication skills.

Responsibilities

• Develop and implement analytical strategies.
• Oversee method development, validation, transfer, and compliance.
• Support regulatory submissions (IND, IMPD, NDA, MAA).
• Ensure methods meet ICH, FDA, EMA standards.
• Guide comparability studies and support tech transfer.
• Collaborate with cross-functional teams including Process Development, Quality, Regulatory, Manufacturing, and Discovery.
• Evaluate new analytical technologies.
• Serve on project teams and support inspections and audits.

Skills

Leadership

Analytical development

Cross-functional collaboration

Regulatory knowledge

Communication skills

Education

Bachelor's in Chemistry, Biochemistry, or related

Tools

Analytical instruments

Job description

Role

Associate Director of Analytical Development and Quality Control, leading strategy and execution of analytical methods to support small molecule biopharmaceutical development from early research to commercialization.

Responsibilities

• develop and implement analytical strategies
• oversee method development, validation, transfer, and compliance
• support regulatory submissions (IND, IMPD, NDA, MAA)
• ensure methods meet ICH, FDA, EMA standards
• guide comparability studies and support tech transfer
• collaborate with cross-functional teams including Process Development, Quality, Regulatory, Manufacturing, and Discovery
• evaluate new analytical technologies
• serve on project teams and support inspections and audits

Requirements

• Bachelor's in Chemistry, Biochemistry, or related
• 8+ years in analytical development within biotech or pharma
• strong expertise in solid oral dosage and biologics analytics preferred
• experience with method validation, regulatory filings, and compliance
• deep knowledge of ICH, FDA, EMA guidelines
• excellent leadership and communication skills

HighValue

• focus on small molecules
• early to late-stage development
• regulatory filings
• GxP
• cross-functional collaboration
• analytical method validation
• support for commercialization

WorkSetup

not specified; likely hybrid or on-site based on industry standards.