Manager, Analytical Sciences - Commercial in United States at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Analytical Sciences - Commercial based in the United States.

This is an opportunity to lead analytical strategy for a commercial portfolio within a science-driven biopharmaceutical environment.
You will help ensure analytical methods, specifications, and control strategies remain compliant, robust, and fit for purpose.
The role works closely with CDMOs supporting small-molecule drug substance and drug product manufacturing.
You will influence product quality, regulatory readiness, manufacturing continuity, and lifecycle management.
The position combines scientific leadership with hands-on review, troubleshooting, investigation, and risk management.
You will collaborate across Quality, Regulatory, Manufacturing, and CMC teams while serving as a trusted analytical subject-matter expert.
The role is remote, with travel to the Boston area and approximately 20–30% travel to CDMO sites as business needs require.

• Lead analytical strategies for commercial products, ensuring methods, specifications, and control strategies remain compliant, scientifically sound, and fit for purpose.
• Manage analytical method transfers, validations, improvements, and lifecycle activities, proactively identifying risks and driving solutions to resolution.
• Support analytical activities for process performance qualification, continued process verification, commercial manufacturing, and stability programs, maintaining strong data quality and regulatory compliance.
• Review and approve analytical documentation, including protocols, reports, specifications, validation packages, certificates of analysis, raw data, chromatographic integrations, and electronic audit trails.
• Oversee analytical activities performed by CDMOs and external laboratories, ensuring timely and compliant deliverables that support product release, supply continuity, and inspection readiness.
• Provide on-site analytical support during critical manufacturing campaigns, validation activities, investigations, and health authority inspections as needed.
• Lead or contribute to investigations involving OOS/OOT results, deviations, and CAPAs, applying sound root-cause analysis and supporting appropriate quality decisions.
• Evaluate analytical risks related to manufacturing, supply-chain, and process changes, including impurity controls and post-approval lifecycle strategies.
• Contribute analytical expertise to regulatory submissions, post-approval changes, Annual Product Reviews/Product Quality Reviews, and health authority responses.
• Serve as a key analytical subject-matter expert, partnering cross-functionally to maintain compliant and effective commercial operations.
• Support continuous improvement and help establish practical, risk-based approaches to analytical oversight across the commercial portfolio.

• Bachelor’s degree in Chemistry or a related scientific discipline, with 7+ years of analytical chemistry experience in a GMP-regulated environment.
• Demonstrated experience supporting commercial small-molecule drug substance and/or drug product programs; analytical development experience is strongly valued.
• Strong technical knowledge of small-molecule drug substances and oral dosage forms, including solid oral and liquid/reconstituted products.
• Hands-on experience with analytical method transfer, validation, troubleshooting, and lifecycle management within GMP environments.
• Strong ability to review analytical data, chromatographic integrations, and electronic audit trails in accordance with ALCOA+, 21 CFR Part 11, and EU GMP Annex 11 expectations.
• Working knowledge of U.S. and European cGMP requirements and applicable ICH guidelines.
• Experience supporting commercial analytical methods and control strategies, including post-approval changes and method improvements.
• Experience contributing to regulatory submissions and supporting health authority inspections is preferred.
• Strong problem-solving and scientific judgment, with the ability to identify analytical risks early and develop practical, compliant solutions.
• Demonstrated ability to collaborate effectively with QC laboratories, CDMOs, external service providers, and internal cross-functional teams.
• Excellent communication and organizational skills, with the ability to manage multiple priorities in a fast-moving environment.
• Comfortable working independently while exercising sound judgment on complex technical and quality matters.
• Willingness and ability to travel approximately 20–30%, particularly during validation campaigns, critical investigations, and inspections, as well as travel to the Boston area as needed.

• Annual base salary: $115,000–$140,000 USD.
• Medical, dental, and vision coverage: 99% of premiums covered by the employer.
• Employer-funded healthcare support and voluntary benefit plans to personalize coverage.
• Company-paid life insurance, AD&D, and disability benefits.
• 401(k) program: dollar-for-dollar employer match on eligible contributions up to 6%.
• Long-term stock incentives and Employee Stock Purchase Plan (ESPP).
• Discretionary quarterly bonus opportunities.
• Flexible wellness benefit designed to support employee well-being.
• Generous paid time off and paid holidays.
• Company-wide shutdown periods.
• Remote work flexibility, with travel requirements based on business needs.
• Opportunity to work alongside experienced, collaborative, and highly engaged colleagues in a science-driven environment.
• Equal opportunity workplace with reasonable accommodations available throughout the recruitment process.