Senior Manager, Analytical Lifecycle Lead

🕒 Outubro 29

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

💵 $150.000 - $180.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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Satsuma Pharmaceuticals, Inc.

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2016

💊 Farmacêutico

🧬 Biotecnologia

Pharmaceuticals • Biotechnology

A Satsuma Pharmaceuticals, Inc. é uma empresa farmacêutica focada no desenvolvimento e na comercialização de terapias para enxaqueca por meio de sua plataforma de drug delivery SMART (Simple MucoAdhesive Release Technology). Seu primeiro produto aprovado, Atzumi™ (STS101), é um pó nasal de di-hidroergotamina (DHE) indicado para o tratamento agudo da enxaqueca, com ou sem aura, em adultos. A empresa destaca publicações e apresentações clínicas e enfatiza a maior eficácia e praticidade de administração proporcionadas por sua abordagem de drug delivery nasal mucoadesivo.

Descrição

• Serve as analytical technical owner and subject-matter expert for Atzumi™, including analytical methods and specifications for raw materials, DHE API, bulk formulation, finished drug product, and device-performance attributes • Establish operational objectives, policies, and procedures for analytical lifecycle management activities • Delegate assignments and provide guidance to cross-functional partners • Serve as primary analytical technical interface with CMOs, contract laboratories, and suppliers • Provide direction, review technical work, and coordinate priorities and deliverables • Maintain the analytical control strategy and analytical knowledge base • Develop and execute risk-based analytical lifecycle plans and changes • Provide technical oversight of analytical method changes, validation, verification, revalidation, and comparability activities • Author or review protocols, data packages, reports, and conclusions generated by external laboratories and manufacturing partners • Establish and govern analytical method performance monitoring • Identify and implement analytical improvements that reduce variability, invalid results, investigation recurrence, testing cycle time, and cost • Provide technical direction and support during analytical deviations, atypical results, OOS and OOT investigations, product complaints, and recurring performance issues • Review investigation plans, data, hypotheses, root-cause conclusions, impact assessments, and CAPA recommendations • Provide analytical leadership for stability programs, including protocol development, method suitability, data and trend review, stability excursions, shelf-life evaluations, annual commitments, and expiry-dating changes • Author and review analytical content supporting post-approval regulatory submissions, annual reports, regulatory commitments, health-authority questions, partner audits, and regulatory inspections • Partner with Quality, Regulatory Affairs, Operations, and external partners to prioritize analytical work, assess risks, support batch and supply decisions, and implement changes • Select and manage external analytical consultants and service providers • Drive the strategy and success of larger analytical lifecycle projects • Execute additional responsibilities, initiatives, and special projects as business needs evolve

🎯 Requisitos

• Bachelor’s degree in analytical chemistry, chemistry, pharmaceutical sciences, or a related scientific discipline required • 6+ years of progressively responsible analytical development, quality control, MSAT, or analytical CMC experience within the pharmaceutical or biotechnology industry • Experience supporting approved commercial products and managing analytical methods through validation, transfer, routine use, performance monitoring, change, and continual improvement • Experience providing technical oversight to CMOs, contract testing laboratories, and suppliers in an external or virtual manufacturing environment • Strong technical knowledge of analytical method development, validation, transfer, method robustness, specifications, stability testing, and analytical data trending • Experience supporting analytical investigations, including OOS, OOT, atypical results, invalid assays, deviations, root-cause analysis, impact assessment, and CAPA development • Working knowledge of applicable FDA requirements, ICH Q2, ICH Q14, data-integrity expectations, and post-approval analytical change management • Experience authoring or reviewing analytical sections of regulatory submissions and supporting regulatory inspections or partner audits • Experience with small-molecule drug products required • Strong project leadership, scientific judgment, data analysis, collaboration, and written and verbal communication skills • Ability to manage multiple priorities and influence external partners without direct authority • Proven ability to advise teams on moderately complex matters and contribute to accountability for outcomes impacting the business segment • Ability to travel domestically and internationally up to 25% • Advanced degree preferred • Experience with dry-powder products, nasal or inhalation products, particle characterization, delivered-dose testing, or drug-device combination products preferred

🏖️ Benefícios

• Health Insurance • Dental & Vision Insurance • Healthcare & Dependent Care FSA • Employee Assistance Program (EAP) • 401(k) Savings Plan • Long-term Incentive Plan • Life Insurance • Accident & Disability Insurance • Telemedicine • Generous Paid Time Off • Company Holidays • Up to 25% domestic and international travel opportunity

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