Associate Director/Director of Pharmaceutical Development
Celcuity
August 11, 2026
Remote friendly (United States)
United States
Operations
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.
- 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.