Senior Manager, Analytical Lifecycle Lead

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Act as the analytical technical owner and subject-matter expert for Atzumi™, overseeing analytical methods and specifications for raw materials, DHE API, bulk formulation, finished drug product, and device performance attributes.

• Set operational objectives, policies, and procedures for managing analytical lifecycle activities.

• Delegate tasks and offer guidance to cross-functional teams.

• Serve as the main analytical technical liaison with CMOs, contract laboratories, and suppliers.

• Provide oversight, review technical work, and coordinate priorities and deliverables.

• Maintain the analytical control strategy and knowledge base.

• Develop and implement risk-based analytical lifecycle plans and modifications.

• Oversee technical aspects of analytical method changes, validation, verification, revalidation, and comparability activities.

• Author or review protocols, data packages, reports, and conclusions produced by external laboratories and manufacturing partners.

• Establish and manage analytical method performance monitoring.

• Identify and implement analytical enhancements to minimize variability, invalid results, investigation recurrence, testing cycle time, and costs.

• Provide technical direction and assistance during analytical deviations, atypical results, OOS and OOT investigations, product complaints, and recurring performance challenges.

• Review investigation plans, data, hypotheses, root-cause conclusions, impact assessments, and CAPA recommendations.

• Offer analytical leadership for stability programs, including protocol creation, method suitability assessments, data and trend evaluations, stability excursions, shelf-life assessments, annual commitments, and expiry-dating adjustments.

• Author and review analytical content for post-approval regulatory submissions, annual reports, regulatory commitments, health authority inquiries, partner audits, and regulatory inspections.

• Collaborate with Quality, Regulatory Affairs, Operations, and external partners to prioritize analytical tasks, evaluate risks, support batch and supply decisions, and implement changes.

• Select and manage external analytical consultants and service providers.

• Propel the strategy and success of more extensive analytical lifecycle projects.

• Undertake additional responsibilities, initiatives, and special projects as business needs evolve.

⛳️ Requirements

• Bachelor's degree in analytical chemistry, chemistry, pharmaceutical sciences, or a related scientific field is required.

• A minimum of 6 years of progressively responsible experience in analytical development, quality control, MSAT, or analytical CMC within the pharmaceutical or biotechnology sector.

• Experience in supporting approved commercial products and managing analytical methods through validation, transfer, routine use, performance monitoring, changes, and continuous improvement.

• Proven experience in providing technical oversight to CMOs, contract testing laboratories, and suppliers in an external or virtual manufacturing setting.

• Strong technical expertise in analytical method development, validation, transfer, method robustness, specifications, stability testing, and analytical data trending.

• Background in supporting analytical investigations, including OOS, OOT, atypical results, invalid assays, deviations, root-cause analysis, impact assessment, and CAPA development.

• Familiarity with applicable FDA regulations, ICH Q2, ICH Q14, data integrity expectations, and post-approval analytical change management.

• Experience in authoring or reviewing analytical sections of regulatory submissions and assisting with regulatory inspections or partner audits.

• Knowledge of small-molecule drug products is essential.

• Strong project leadership, scientific judgment, data analysis, collaboration, and both written and verbal communication skills.

• Ability to manage multiple priorities and influence external partners without direct authority.

• Demonstrated capability to advise teams on moderately complex issues and contribute to accountability for outcomes that affect the business segment.

• Willingness to travel domestically and internationally up to 25% of the time.

• An advanced degree is preferred.

• Experience with dry-powder products, nasal or inhalation products, particle characterization, delivered-dose testing, or drug-device combination products is 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