Senior Manager, Analytical Lifecycle Lead

. 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 .

Posted 10/29/2026full-timeRemote • North Carolina • United StatesSenior💰 $150,000 - $180,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in analytical method development, validation, and lifecycle management within the pharmaceutical industry, with a strong focus on regulatory compliance and technical oversight. Proven ability to lead cross-functional teams and manage analytical projects effectively while ensuring data integrity and quality control.

Highest-signal resume keywords

Analytical Method DevelopmentRegulatory SubmissionsTechnical OversightProject LeadershipRoot-Cause Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical ChemistryAnalytical DevelopmentQuality ControlMethod ValidationStability TestingData AnalysisSpecifications ManagementChange ManagementCAPA DevelopmentAnalytical Data Trending

Soft Skills

CollaborationWritten CommunicationVerbal CommunicationScientific JudgmentInfluencing Skills

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryFDA RequirementsICH Q2ICH Q14Analytical Lifecycle ManagementOOS InvestigationsDrug-Device Combination ProductsDry-Powder ProductsNasal or Inhalation Products

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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