Associate Director – Pharmaceutical Development

🔥 0 minutes ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

💵 $180k - $210k / year

⏰ Full Time

🟠 Senior

👔 Director

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Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

📋 Description

• Manage drug formulation technology transfers, scale-up, and manufacturing processes • Serve as the primary technical liaison between Celcuity and external CDMOs • Direct late-stage drug product design, scale-up, and manufacturing robustness using QbD principles • Oversee external vendors and laboratories for clinical, process validation, and commercial batch production • Oversee production of drug product batches for clinical trial materials and commercial production • Author and review CMC documents for global IND, IMPD, NDA, and MAA filings • Partner with analytical development, supply chain, quality assurance, and clinical operations in a matrixed team • Manage project timelines, program risks, and financial forecasting for outsourced operations • Manage day-to-day operations and strategic alignment with global CDMO partners • Lead technical transfers from internal discovery to external clinical facilities • Identify alternative vendors and process bottlenecks to mitigate outsourced supply-chain risk • Troubleshoot technical manufacturing issues, deviations, and OOS results at external sites

🎯 Requirements

• Ph.D., Master's degree, or Bachelor's degree in Chemistry, Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or closely related field • Proven track record scaling manufacturing processes from pilot scale through cGMP environments to commercial production • Strong negotiation, conflict-resolution, and remote cross-functional communication abilities • 8+ years of experience in small molecule drug product development • Understanding of physical pharmacy, crystallization, and material science • Minimum 3 years directly managing small molecule CDMOs through scale-up and clinical supply campaigns • Comprehensive understanding of ICH guidelines (Q1-Q11), cGMP requirements, and Quality by Design (QbD) principles

🏖️ Benefits

• Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays