Associate Director/Director of Pharmaceutical Development

About the Role

The Associate Director/Director, Pharmaceutical Development manages drug formulation technology transfers, scale-up and manufacturing processes, and is an integral member of cross-functional CMC (Chemistry, Manufacturing, and Controls) teams. This position focuses on external oversight, serving as the primary technical liaison between Celcuity and Contract Development and Manufacturing Organizations (CDMOs).

Responsibilities

• Direct late-stage drug product design, scale-up, and manufacturing robustness using Quality by Design (QbD) principles.
• Oversee external vendors and laboratories for clinical, process validation, and commercial batch production.
• Oversee the production of drug product batches to support clinical trial material needs and commercial production.
• Author and review CMC documents for global filings (IND, IMPD, NDA, MAA).
• Partner with analytical development, supply chain, quality assurance, and clinical operations in a matrixed team environment.
• 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 of formulation and manufacturing processes from internal discovery to external clinical facilities.
• Mitigate risk across the outsourced supply chain by identifying alternative vendors and process bottlenecks.
• Troubleshoot technical manufacturing issues, deviations, and out-of-specification (OOS) results at external sites.

Requirements

• Ph.D., Master's degree, or Bachelor’s degree in Chemistry, Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or a closely related field.
• Proven track record scaling up manufacturing processes from pilot scale to 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, with an understanding of physical pharmacy, crystallization, and material science.
• Minimum of 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.

About Celcuity

Celcuity is a commercial biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting.

Pay

The anticipated base pay range for this role is $180,000 to $210,000, depending on experience. The exact base pay offered will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience. The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package.

Benefits

• Medical, dental, and vision insurance
• 401(k) match
• Paid time off (PTO)
• Paid holidays