CMC Analytical Development Director: Strategy & Validation

Scorpion Therapeutics; Boston (MA); On-site; USD 165,000 - 250,000; Full time

Benefits offered by this job

Comprehensive benefits

Discretionary bonus

401(k)

Job summary

Scorpion Therapeutics seeks a Sr. Director of Analytical Development to lead phase-appropriate method development, validation, and product characterization for multiple programs. You will oversee drug substance/product analytics with CDMOs and drive regulatory-ready data for IND/IMPD submissions.

The role requires a PhD plus 10+ years in small molecule analytics, deep cGMP expertise, and strong leadership across global teams. US-based with occasional travel; competitive compensation and benefits.

Qualifications

• PhD strongly preferred in chemistry, pharmaceutical sciences, or related field.
• 10+ years small molecule pharmaceutical industry experience.
• Extensive early-phase analytical development experience for small molecule oral solid dosage forms.
• Deep expertise in cGMP and ex-US regulatory requirements.

Responsibilities

• Lead analytical strategy for phase-appropriate method development, validation, and product characterization for multiple programs.
• Lead drug substance and drug product analytical development at third-party vendors, including method implementation, qualification/validation, and transfer (pre-IND through registrational programs).
• Review method validation protocols/reports and test data for release, stability, and characterization.
• Save/store documentation; generate stability result tables; file stability data for expiry and shelf-life assignments.
• Lead specification settings based on batch history and supporting analytical data.
• Serve as the CMC analytical representative in program development teams.
• Act as subject matter expert and role model for junior analytical scientists.
• Contribute to regulatory filing analytical CMC content (regulatory starting material justifications, specification justification, discriminatory/quality-control dissolution, structural elucidations).
• Draft/review internal technical reports and analytical sections for global submissions (IND, IMPD, NDA, MAA, etc.) and regulatory responses.
• Partner with Quality on analytical OOE/OOT/OOS investigations, deviations, and troubleshooting; participate in batch record review.

Skills

Analytical strategy leadership

cGMP expertise

CDMO management

Regulatory filings (IND/IMPD/MAA)

Small molecule analytics

Project management

Stability studies

Education

PhD in Chemistry or Pharmaceutical Sciences

Job description

Scorpion Therapeutics seeks a Sr. Director of Analytical Development to lead phase-appropriate method development, validation, and product characterization for multiple programs. You will oversee drug substance/product analytics with CDMOs and drive regulatory-ready data for IND/IMPD submissions.

The role requires a PhD plus 10+ years in small molecule analytics, deep cGMP expertise, and strong leadership across global teams. US-based with occasional travel; competitive compensation and benefits.