Senior Director, Analytical Chemistry

🕒 August 25

❄️ Minnesota – Remote

❄️ Minnesota – Remote

💵 $230k - $240k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 3%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

📋 Description

• Provide strategic and operational leadership for Celcuity’s small molecule pipeline and support of commercial assets • Establish robust CMC analytical methods, specifications, and stability programs at CDMOs • Provide streamlined oversight for outsourced PK and toxicokinetic (TK) assays • Serve as the subject matter expert on analytical development approaches, techniques, and testing for APIs and drug products from early development through commercial support • Lead analytical development and material characterization for existing and new compounds appropriate to the phase of development • Establish phase-appropriate strategies for small molecule drug substance and drug product analytical methods, including solid-state characterization and impurity profiling • Provide expertise in DSC, IR, particle size, GC, mass spectrometry, XRD, and common pharmaceutical methodologies • Oversee external CDMO partners in analytical method development, optimization, qualification, validation, and transfer • 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 • Investigate and resolve complex analytical deviations, OOS results, and stability trends as technical authority • Author and review analytical CMC sections and relevant bioanalytical components for IND through NDA stage and ROW regulatory submissions • Perform other duties as assigned

🎯 Requirements

• 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 • Experience with early development activities including IND-enabling development • Experience with API and impurity testing; individuals with drug product only experience will not be considered • Preferred direct experience supervising outsourced biological sample 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 • Knowledge 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

🏖️ Benefits

• Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays