Reporting to the Executive Director of Pharmaceutical Development & Operations, the Senior Director provides strategic and operational leadership for Celcuity’s small molecule pipeline and support of commercial assets. This role focuses primarily on establishing robust CMC analytical methods, specifications, and stability programs at CDMOs, while providing streamlined oversight for outsourced PK and toxicokinetic (TK) assays. The Senior Director will be the subject matter expert on analytical development approaches, techniques and testing, APIs and drug products ranging from early development to commercial support.
Responsibilities:
Lead analytical development and material characterization for existing and new compounds appropriate to the phase of development.
Establish the phase-appropriate strategy for small molecule drug substance (DS) and drug product (DP) analytical methods, including, solid-state characterization, and impurity profiling.
Provide expertise in various analytical testing including DSC, IR, particle size, GC, mass spectrometry, XRD, and common pharmaceutical methodologies.
Oversee external CDMO partners in the development, optimization, qualification, validation, and transfer of robust analytical methods. Troubleshoot analytical testing issues and non-conformances, determine root causes, and optimize testing procedures.
Support formulation development with material testing, impurity and degradation identification. Support pre-clinical test article characterization.
Serve as the technical authority to investigate and resolve complex analytical deviations, out-of-specification (OOS) results, and stability trends.
Author and review analytical CMC sections and relevant bioanalytical components for IND through NDA stage, and for ROW regulatory submissions.
Other duties as assigned.
Qualifications:- PhD, Master’s, or Bachelor’s degree in a physical science field, ideally analytical chemistry, or closely related sciences.≥ 12 years in analytical chemistry of small molecule testing. Biologics and similar large molecule experience will not contribute to the experience total.
- Experienced with early development activities including IND-enabling development.
- Adept with API and impurity testing. Individuals with drug product only experience will not be considered.
- Preferred direct experience supervising outsourced biological sample analysis (i.e., plasma concentration analysis) using LC-MS/MS in compliance with GLP and FDA/EMA Bioanalytical Method Validation guidelines.
- Expertise in analytical technologies including LC, GC, NMR, MS, XRPD, and other relevant methodologies used for elucidation and purity determination.
- Well-informed of FDA, EMA, 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.
- Strong technical and analytical skills with advanced knowledge in 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 and delegate
- 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 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. The Phase 3 VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and either fulvestrant or letrozole for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer. A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. 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 $230,000 - $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.
