Senior Director, Analytical Chemistry

🕒 il y a 28 jours

❄️ Minnesota – Distant

❄️ Minnesota – Remote

💵 $230 000 - $240 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 2%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Celcuity

Site WebLinkedInTous les Emplois

51 - 200 employés

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

Healthcare • Biotechnology • Pharmaceuticals

Celcuity est une entreprise de biotechnologie en phase clinique développant des thérapies ciblées qui bloquent la voie PI3K/AKT/mTOR (PAM) pour traiter plusieurs tumeurs solides. Son principal candidat, le gedatolisib, est un inhibiteur potentiel de première classe pan-PI3K et mTORC1/2 en cours d'évaluation dans des essais sur le cancer du sein et de la prostate. L'entreprise avance un pipeline ciblé visant à offrir des traitements contre le cancer transformateurs et ciblés et mène un développement clinique et une recherche basée sur les données pour soutenir l'adoption réglementaire et médicale.

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

🎯 Exigences

• 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

🏖️ Avantages

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