Head of Analytical Development & QC – Small Molecules

Scorpion Therapeutics

Waltham (MA)

On-site

USD 180,000 - 240,000

Full time

5 days ago

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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.