Director or Senior Director, API Development

Position Summary:

We are seeking a Director or Senior Director, API Development, who will report to the Executive Director of Pharmaceutical Development. You will be the technical expert for current API synthesis production and will lead creation, optimization, and management of additional API entities as part of new compound/formulation development activities.

Responsibilities:

• Provide leadership and technical guidance for selection, transfer, and management of new CDMO manufacturing activities.
• Lead current drug substance manufacturing process and optimize for continuous improvement of material.
• Support ongoing CDMO manufacturing activities and troubleshoot issues and non-conformities.
• Determine and resolve gaps for regulatory compliance with drug substance manufacturing and development.
• Support formulation development with drug substance optimization, impurity identification, and pre-clinical study coverage involvement.
• Author and review drug substance IND-enabling protocols, reports, and regulatory submissions.
• Engage and support formulation development with new entity optimization and synthetic route creation/advancement.
• Produce intellectual patent assessments and complete development projects intended for furthering IP generation.
• Other duties as assigned.

Qualifications:

• PhD, Master’s, or Bachelor’s degree in a physical science field, ideally chemistry, chemical engineering, or biomanufacturing.
• ≥ 8 years in small molecule medicinal chemistry, API development, and/or manufacturing.
• Experienced with early development activities including IND-enabling development and authoring.
• Managed CDMOs for initial development, manufacturing, process validation, and transfer activities.
• Knowledge of analytical technologies including LC, GC, NMR, MS, XRPD, and other relevant methodologies used for elucidation and purity determination.
• Well-informed of FDA, EU, and ICH guidelines for drug substance manufacturing and quality assurance.
• Excellent written and verbal communication skills, with ability to influence and build credibility at all levels.
• Strong interpersonal skills for interacting with employees and leaders across various levels and functions.
• Attention to detail and ability to manage multiple processes and documentation requirements.
• Highly organized with documentation associated with project planning, communication, and resulting reports.
• Strong technical and analytical skills with advanced knowledge in ChemDraw, and MS Office including Word, Excel, and PowerPoint.
• Ability to work in a team or independently as required.
• Outstanding organizational skills with the ability to prioritize.
• Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment.
• Maintain a positive, approachable and professional attitude.

About Us:

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth.

Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going.

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 $220,000 - $240,000 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.

Notice to Recruiters/Staffing Agencies

Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly.

We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Celcuity’s receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Celcuity and such organization and will be considered unsolicited. Celcuity will not be responsible for related fees.