Associate Director/Director of Pharmaceutical Development

Scorpion Therapeutics; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a senior CMC leader to drive late-stage drug product design, scale-up, and manufacturing robustness using QbD principles. You will oversee external vendors for clinical and commercial batches, author regulatory CMC documents, and coordinate with cross-functional teams in a matrixed environment.

The role requires 8+ years in small molecule development with direct CDMO management experience, plus deep ICH/gMP/QbD knowledge.

Qualifications

• Ph.D./M.S./B.S. in a relevant scientific discipline.
• Experience scaling up from pilot to cGMP/commercial production.
• Strong negotiation and cross-functional communication skills.
• Deep knowledge of ICH Q1–Q11, cGMP, and QbD principles.

Responsibilities

• Direct late-stage drug product design, scale-up, and manufacturing robustness using QbD.
• Oversee external vendors and labs for clinical, process validation, and commercial batches.
• Authorize CMC documents for global regulatory filings (IND, IMPD, NDA, MAA).
• Partner with analytical development, supply chain, quality assurance, and clinical operations in a matrixed environment.
• Manage outsourcing timelines, program risks, and financial forecasting.
• Provide vendor governance and day-to-day oversight with global CDMO partners.
• Lead technology transfers of formulation and manufacturing processes to external facilities.
• Identify alternative vendors and bottlenecks to mitigate outsourcing risk.
• Troubleshoot manufacturing deviations and OOS at external sites.

Skills

Vendor governance

Cross-functional leadership

Regulatory knowledge

Negotiation

Education

Ph.D./M.S./B.S. in Chemistry/Pharmaceutics/Pharmaceutical Sciences/Chemical Engineering

Job description

Responsibilities:

• Direct late-stage drug product design, scale-up, and manufacturing robustness using Quality by Design (QbD).
• Oversee external vendors and laboratories for clinical, process validation, and commercial batch production; ensure drug product batches for clinical trial and commercial needs.
• Author/review CMC documents for global regulatory filings (IND, IMPD, NDA, MAA).
• Partner with analytical development, supply chain, quality assurance, and clinical operations in a matrixed environment.
• Manage outsourced operations: timelines, program risks, and financial forecasting.
• Provide vendor governance and day-to-day oversight with global CDMO partners.
• Lead technical technology transfers of formulation and manufacturing processes to external clinical facilities.
• Manage outsourcing risk by identifying alternative vendors and process bottlenecks.
• Troubleshoot technical manufacturing issues, deviations, and out-of-specification (OOS) results at external sites.

Qualifications:

• Ph.D./Master’s or Bachelor’s degree in Chemistry, Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or related field.
• Proven experience scaling up manufacturing from pilot scale to cGMP and commercial production.
• Strong negotiation, conflict-resolution, and remote cross-functional communication skills.
• 8+ years in small molecule drug product development (physical pharmacy, crystallization, material science).
• 3+ years directly managing small molecule CDMOs through scale-up and clinical supply campaigns.
• Deep knowledge of ICH (Q1–Q11), cGMP requirements, and QbD principles.