Associate Director – Pharmaceutical Development

This is a fully remote position, open to applicants in Minnesota.

📋 Description

• Oversee the transfer of drug formulation technologies, scaling processes, and manufacturing activities.

• Act as the main technical contact between Celcuity and external Contract Development and Manufacturing Organizations (CDMOs).

• Lead the design and robustness of late-stage drug products, scaling, and manufacturing using Quality by Design (QbD) methodologies.

• Supervise external vendors and laboratories involved in clinical studies, process validation, and commercial batch production.

• Manage the production of drug product batches for both clinical trial materials and commercial manufacturing.

• Create and review Chemistry, Manufacturing, and Controls (CMC) documentation for global IND, IMPD, NDA, and MAA submissions.

• Collaborate with teams in analytical development, supply chain, quality assurance, and clinical operations within a matrix structure.

• Oversee project timelines, program risks, and financial predictions for outsourced activities.

• Handle daily operations while ensuring strategic alignment with global CDMO partners.

• Facilitate technical transfers from internal discovery teams to external clinical facilities.

• Identify alternative vendors and address process bottlenecks to alleviate risks in the outsourced supply chain.

• Resolve technical manufacturing challenges, deviations, and out-of-specification (OOS) results at external sites.

⛳️ Requirements

• A Ph.D., Master's degree, or Bachelor's degree in Chemistry, Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or a closely related discipline.

• Demonstrated experience in scaling manufacturing processes from pilot stages through current Good Manufacturing Practices (cGMP) to commercial production.

• Exceptional negotiation, conflict resolution, and remote cross-functional communication skills.

• A minimum of 8 years of experience in the development of small molecule drug products.

• Knowledge of physical pharmacy, crystallization processes, and material sciences.

• At least 3 years of direct experience managing small molecule CDMOs during scale-up and clinical supply initiatives.

• Thorough understanding of ICH guidelines (Q1-Q11), cGMP standards, and Quality by Design (QbD) principles.

🏝️ Benefits

• Annual performance incentive bonus.

• New hire equity package.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) matching.

• Paid time off (PTO).

• Paid holidays.