Senior Manager, Analytical Lifecycle Lead

Description

Position Summary:

The Analytical Lifecycle Lead is responsible for the technical ownership and lifecycle management of analytical methods supporting AtzumiTM commercial supply. This role coordinates analytical activities across active pharmaceutical ingredients (API), excipients, bulk formulation, finished drug product, device-performance testing, and stability programs. The role serves as Satsuma Pharmaceuticals' primary analytical technical interface with contract manufacturers, contract laboratories, suppliers, regulatory agencies, and collaborates internally with Quality, Regulatory Affairs, and Operations. The Analytical Lifecycle Lead ensures that analytical methods remain fit for their intended purpose, appropriately validated, routinely monitored, and capable of supporting product quality, regulatory compliance, and reliable commercial supply. The successful candidate works on issues where analysis of situations or data requires conceptual thinking and an in-depth knowledge of organizational objectives, implementing policies and selecting methods, techniques, and evaluation criteria for obtaining results, and drives the strategy and success of larger projects which contribute to multiple areas of the organization.

Key Responsibilities:

• Serve as the analytical technical owner and subject-matter expert for AtzumiTM, including analytical methods and specifications for raw materials, DHE (dihydroergotamine) API, bulk formulation, finished drug product, and relevant device-performance attributes.
• Establish operational objectives, policies, and procedures for analytical lifecycle management activities, delegating assignments and providing guidance to cross-functional partners.
• Serve as the primary analytical technical interface with CMOs, contract laboratories, and suppliers, providing direction, reviewing technical work, and coordinating priorities and deliverables. Interact regularly with lower and/or senior management on matters concerning several functional areas and external partners, requiring the ability to persuade others in sensitive, complex situations while preserving relationships.
• Maintain the analytical control strategy and analytical knowledge base, including method purpose, performance requirements, validation status, critical method parameters, system-suitability requirements, risk mitigations, and the scientific rationale supporting registered methods and specifications.
• Develop and execute risk-based analytical lifecycle plans and changes that improve analytical robustness, optimize cycle times, and mitigate risk.
• 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 method variability, invalid results, investigation recurrence, testing cycle time, and cost while maintaining product quality and regulatory compliance.
• Provide technical direction and support to CMOs 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 technical support for changes to expiry dating.
• 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, as needed.
• Drive the strategy and success of larger analytical lifecycle projects which contribute to multiple areas of the organization, implementing policies and selecting methods, techniques, and evaluation criteria for obtaining results.
• Proactively identify, assume, and execute additional responsibilities, initiatives, and special projects as business needs evolve.

Minimum Requirements Education/Experience:

• Bachelor's degree in analytical chemistry, chemistry, pharmaceutical sciences, or a related scientific discipline required; advanced degree preferred.
• Demonstrated ability to work on issues where analysis requires conceptual thinking and in-depth knowledge of organizational objectives, implementing policies and selecting methods and techniques for obtaining results.
• 6+ years of progressively responsible analytical development, quality control, MSAT, or analytical CMC experience within the pharmaceutical or biotechnology industry.
• Demonstrated 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; experience with dry-powder products, nasal or inhalation products, particle characterization, delivered-dose testing, or drug-device combination products preferred.
• Strong project leadership, scientific judgment, data analysis, collaboration, and written and verbal communication skills, with the ability to manage multiple priorities and influence external partners without direct authority.
• Ability to travel domestically and internationally anticipated at up to 25%, including visits to contract manufacturers, laboratories, and suppliers.
• Proven ability to advise teams on moderately complex matters and contribute to accountability for outcomes impacting the business segment.

Benefits and Pay:

The expected salary range for this position is $150,000.00 - $180,000.00 USD. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law.

Satsuma Pharmaceuticals is committed to providing its employees with benefit options that are comprehensive, competitive, and that individual employees can tailor to their and their families' specific needs. Eligible employees are offered 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, and Company Holidays.