Senior Manager, Analytical Lifecycle Lead

Job not on LinkedIn

🕒 4 days ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $150k - $180k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 0%

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Satsuma Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2016

💊 Pharmaceuticals

🧬 Biotechnology

Pharmaceuticals • Biotechnology

Satsuma Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing therapies for migraine using its SMART (Simple MucoAdhesive Release Technology) drug-delivery platform. Its first approved product, Atzumi™ (STS101), is a dihydroergotamine (DHE) nasal powder indicated for the acute treatment of migraine with or without aura in adults. The company highlights clinical publications and presentations and emphasizes improved efficacy and administration via its mucoadhesive nasal delivery approach.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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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