Senior Manager, Analytical Chemistry

🕒 Agosto 11

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $115.000 - $135.000 / ano

⏰ Tempo Integral

🟠 Sênior

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Enliven Therapeutics

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

A Enliven Therapeutics é uma empresa dedicada ao desenvolvimento de soluções inovadoras para o tratamento do câncer. Focam na criação de inibidores de quinase de pequenas moléculas, projetados para melhorar a eficácia, segurança e conveniência para o paciente. Com programas que visam alvos como BCR-ABL, HER2 e vias adicionais, a Enliven Therapeutics busca aprimorar a precisão e a seletividade dos tratamentos contra o câncer, combater a resistência e abordar metástases cerebrais. A empresa se orgulha de ter uma equipe de desenvolvedores de medicamentos experientes e visa ajudar pacientes com câncer a viverem vidas mais longas e melhores.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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