Senior Manager, Analytical Chemistry

🕒 vor 1 Monat

🇺🇸 Vereinigte Staaten – Remote

💵 $115.000 - $135.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Manager

👻 Geisterscore 2%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Lebenslauf hochladen

Enliven Therapeutics

WebsiteLinkedInAlle Stellen

11 - 50 Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

🧬 Biotechnologie

Healthcare • Consulting • Biotechnology

Enliven Therapeutics ist ein Unternehmen, das sich der Entwicklung innovativer Lösungen für die Krebsbehandlung widmet. Es konzentriert sich auf die Entwicklung von kleinen Molekül-Kinase-Inhibitoren, die darauf abzielen, die Wirksamkeit, Sicherheit und den Komfort für Patienten zu verbessern. Mit Programmen, die auf BCR-ABL, HER2 und zusätzliche Signalwege abzielen, strebt Enliven Therapeutics an, die Präzision und Selektivität von Krebstherapien zu erhöhen, Resistenzen zu bekämpfen und Hirnmetastasen anzugehen. Das Unternehmen ist stolz auf ein Team erfahrener Arzneimittelentwickler und möchte Krebspatienten dabei helfen, länger und besser zu leben.

Beschreibung

• Develop and execute phase-appropriate analytical and control strategies for assigned drug substance and drug product programs • Independently lead analytical programs, vendor relationships, and technical deliverables • Select, qualify, and manage CROs, CDMOs, CMOs, and contract laboratories • Oversee analytical method development, optimization, qualification, validation, verification, transfer, and lifecycle management • Review analytical methods, protocols, raw data summaries, validation and transfer packages, certificates of analysis, stability reports, and technical documents • Develop, evaluate, and justify specifications and acceptance criteria for drug substance and drug product • Support impurity and degradant identification, characterization, qualification, and control • Design and manage non-GMP, GLP, and cGMP stability programs and provide expiry-dating recommendations • Provide analytical oversight for routine testing, manufacturing, batch disposition, clinical supply, material release, retest dates, and expiry dating • Lead or critically review deviations, laboratory investigations, atypical results, OOS/OOT events, root-cause assessments, impact assessments, and CAPAs • Provide risk-based guidance for method failures, unexpected results, sample preparation issues, instrument events, and complex analytical challenges • Author and review analytical CMC content and source documents for regulatory submissions and health-authority responses • Represent analytical CMC in program and project-team meetings and collaborate with cross-functional functions • Develop and improve analytical workflows, procedures, trackers, templates, and governance practices • Communicate complex technical information, mentor partner scientists, and promote scientific rigor and continuous improvement • Coordinate analytical samples, reference standards, and associated documentation

🎯 Anforderungen

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related discipline with 6+ years of relevant pharmaceutical or biotechnology experience; M.S. with 9+ years; or B.S. with 12+ years • Equivalent combinations of education and directly relevant experience will be considered • Substantial experience supporting analytical development and quality control of small-molecule drug substance and drug product across multiple development stages • Experience preferably including solid oral dosage forms • Demonstrated ability to manage analytical activities performed by CROs, CDMOs, CMOs, and contract laboratories • Strong working knowledge of HPLC/UHPLC, dissolution, GC, spectroscopy, moisture analysis, and mass spectrometry • Strong knowledge of analytical method development, qualification, validation, transfer, and lifecycle management • Ability to interpret applicable ICH, FDA, and global regulatory expectations • Working knowledge of GLP, cGMP, laboratory controls, data integrity principles, and current analytical development and quality-control practices • Experience investigating or reviewing deviations, atypical data, OOS/OOT results, method failures, and stability issues • Experience authoring or contributing to analytical CMC sections, technical reports, control strategies, specification justifications, and regulatory submissions • Proven project management skills, sound judgment, and ability to manage multiple priorities independently • Excellent written and verbal communication skills, strong attention to detail, and ability to collaborate and influence without formal authority • Preferred: late-stage analytical development, registration, process validation, commercialization readiness, or post-approval analytical lifecycle management • Preferred: global regulatory submissions and responses to health-authority questions or inspection observations • Preferred: impurity profiling, forced degradation, LC-MS/HRMS, NMR, spectroscopy, structural elucidation, or complex-matrix characterization • Preferred: QC laboratory operations, laboratory quality systems, inspection readiness, or technical team leadership • Preferred: risk-based approaches in lean, virtual, or highly outsourced clinical-stage biotechnology environments • Occasional evening, weekend, holiday, and on-call work may be required • Background screen required as a condition of employment

🏖️ Vorteile

• Benefits are included • Bonus may be provided • Equity may be provided • Remote work arrangement • 40-hour work week • Equal opportunity employer