Senior Analytical Lifecycle Lead — Methods & Strategy

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, 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