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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 will focus on external oversight, serving as the primary technical liaison between Celcuity and Contract Development and Manufacturing Organizations (CDMOs). Key responsibilities include overseeing external CDMO partners and authoring documentation in support of regulatory submissions (domestic and international).  This role prioritizes vendor governance, technology transfer, and managing outsourced operations.

Responsibilities:

• Process & Formulation Design: Direct late-stage drug product design, scale-up, and manufacturing robustness using Quality by Design (QbD) principles.
• CDMO Management and Production Management: 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.
• Regulatory Submissions: Author/review CMC documents for global filings (IND, IMPD, NDA, MAA).
• Cross-Functional Team Member: Partner with analytical development, supply chain, quality assurance, and clinical operations in a matrixed team environment.
• Budget & Resource Oversight: Manage project timelines, program risks, and financial forecasting for outsourced operations.
• Vendor Governance: Manage day-to-day operations and strategic alignment with global CDMO partners.
• Technology Transfer: Lead technical transfers of formulation and manufacturing processes from internal discovery to external clinical facilities.
• Risk Management: Mitigate risk across the outsourced supply chain by identifying alternative vendors and process bottlenecks.
• CMC Technical Leadership: Troubleshoot technical manufacturing issues, deviations, and out-of-specification (OOS) results at external sites.

Qualifications:

• Education: Ph.D. / Master's degree or Bachelor’s degree in Chemistry, Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or a closely related field.
• Manufacturing Knowledge: Proven track record scaling up manufacturing processes from pilot scale to cGMP environments to commercial production.
• Communication Skills: Strong negotiation, conflict-resolution, and remote cross-functional communication abilities.

• Small Molecule Expertise: 8+ years of experience in small molecule drug product development, with an understanding of physical pharmacy, crystallization, and material science.
• External Oversight: Minimum of 3 years directly managing small molecule CDMOs through scale-up and clinical supply campaigns.
• Regulatory & Quality Knowledge: 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.

Celcuity is an Equal-Opportunity Employer.

Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $180,000 to $210,000 DOE. The exact base pay offered for this role 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. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.

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