Senior Manager, Analytical Lifecycle Lead

Satsuma Pharmaceuticals, Inc.; United States; On-site; USD 150,000 - 180,000; Full time

Benefits offered by this job

Health Insurance

Dental & Vision Insurance

401(k) Savings Plan

Long-term Incentive Plan

Life Insurance

Telemedicine

Generous Paid Time Off

Company Holidays

Job summary

Satsuma Pharmaceuticals, Inc. is seeking an Analytical Lifecycle Lead to own analytical methods across API, excipients, formulation, device-performance, and stability programs.

This role interfaces with CMOs and laboratories to ensure methods remain fit-for-purpose and compliant, supporting commercial supply and regulatory submissions. You will establish lifecycle plans, oversee method changes, and drive improvements to reduce variability, cycle times, and cost while maintaining quality and

Qualifications

• Bachelor's degree in analytical chemistry, chemistry, pharmaceutical sciences, or related discipline required; advanced degree preferred.
• Ability to work on issues requiring conceptual thinking and policy interpretation.
• 6+ years of progressively responsible analytical development, quality control, MSAT, or analytical CMC experience.
• Experience supporting approved commercial products and managing analytical methods through validation, transfer, and monitoring.
• Experience providing technical oversight to CMOs, contract labs, and suppliers.
• Strong knowledge of analytical method development, validation, transfer, and stability testing.
• Experience supporting analytical investigations including OOS, OOT, deviations, CAPA.
• FDA, ICH Q2, ICH Q14, data integrity and post-approval change management familiarity.
• Experience authoring/reg. submissions analytical sections and regulatory inspections.
• Experience with small-molecule products; dry-powder nasal/inhalation products preferred.
• Strong leadership, collaboration, and communication; ability to manage multiple priorities.

Responsibilities

• Serve as analytical technical owner for AtzumiTM including methods and specs.
• Establish policies and procedures for analytical lifecycle management.
• Interface with CMOs, labs, and suppliers; prioritize deliverables and maintain relationships.
• Maintain analytical control strategy and knowledge base, including validation and parameters.
• Develop and execute risk-based analytical lifecycle plans to improve robustness and reduce cycle time.
• Oversee method changes, validation, verification, and comparability; review external data.
• Monitor method performance; drive improvements to reduce variability and cost.
• Provide direction during deviations, OOS/OT investigations and CAPA development.
• Lead stability program activities and expiry dating support.
• Author/review analytical content for regulatory submissions and inspections.
• Collaborate with QA, Regulatory, Operations to prioritize work and manage risk.
• Select and manage external analytics consultants and service providers.
• Drive large lifecycle projects and policy-driven methodologies.
• Take on additional responsibilities as business needs evolve.

Skills

Analytical chemistry

Regulatory knowledge

Project leadership

Communication skills

Collaboration

Travel willingness

Education

Bachelor's degree in analytical chemistry / related

Advanced degree preferred

Job description

Satsuma Pharmaceuticals is a biopharmaceutical company preparing to launch AtzumiTM (dihydroergotamine (DHE) nasal powder), a novel therapeutic product approved in the US for the acute treatment of migraine. AtzumiTM incorporates proprietary advanced powder and device technology (SMART - Simple MucoAdhesive Release Technology™) and is designed to be easy-to-use, easy-to-carry and for quick self-administration.

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.

EEO & Employment Eligibility:

Satsuma Pharmaceuticals is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. Satsuma Pharmaceuticals also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law.