Manager, Analytical Development and Quality Control

About the role

The Manager, Analytical Development and Quality Control provides strategic and technical leadership for analytical CMC activities across multiple programs, with a strong emphasis on technology transfer and knowledge management. This role ensures successful transfer of analytical methods and associated knowledge to internal teams and external stakeholders, enabling consistent execution across development and manufacturing sites.

Responsibilities

• Strategically lead and manage analytical CMC activities across multiple programs, ensuring alignment with ICH guidelines.
• Develop, validate, and transfer analytical methods, and ensure their lifecycle management.
• Interpret data from a range of analytical techniques to support sound technical decision-making.
• Drive robust knowledge management practices through high-quality technical writing, documentation, and data governance.
• Establish and clearly communicate analytical control strategies across cross-functional teams, ensuring alignment and scientific rigor.
• Author and review validation, transfer, and investigation reports, and interact with regulatory agencies.
• Oversee external partners (e.g., CDMOs) and manage outsourced analytical activities.
• Support informed decision-making by maintaining continuity of analytical knowledge and coordinating with internal teams and external partners.

Requirements

• Master's degree in Chemistry, Analytical Chemistry, or a related field with 8–10+ years of relevant experience, or PhD in a similar discipline with 5–8+ years of relevant experience.
• Demonstrated leadership experience managing analytical CMC activities across multiple programs.
• Strong expertise in analytical method development, validation, transfer, and lifecycle management in compliance with ICH guidelines.
• General understanding of key analytical methods (e.g., HPLC/UPLC, GC, KF, ICP-MS, IC, XRPD, PSD) with the ability to interpret data and guide technical decisions.
• Proven experience authoring, reviewing, and approving analytical sections of regulatory submissions (INDs, IMPDs, NDAs, and global filings).
• Significant experience supporting NDA submissions and interacting with regulatory agencies.
• Strong technical writing skills for preparation of validation reports, transfer reports, investigation reports, and regulatory documentation.
• Ability to effectively communicate and justify analytical control strategies within cross-functional teams (Quality, Regulatory, Process Development) and with external stakeholders.
• Strong leadership, communication, and project management skills in a cross-functional environment.
• Strong technical writing and authorship skills, with the ability to prepare, review, and approve analytical reports and CMC documentation to support internal decision-making and knowledge management.

Qualifications

• MS in Chemistry, Analytical Chemistry, or a related field with 8–10+ years of relevant experience, or PhD in a similar discipline with 5–8+ years of relevant experience.

Skills

• Strong expertise in analytical method development, validation, transfer, and lifecycle management in compliance with ICH guidelines.
• General understanding of key analytical methods (e.g., HPLC/UPLC, GC, KF, ICP-MS, IC, XRPD, PSD).
• Proven experience authoring, reviewing, and approving analytical sections of regulatory submissions (INDs, IMPDs, NDAs, and global filings).
• Significant experience supporting NDA submissions and interacting with regulatory agencies.
• Strong technical writing skills for preparation of validation reports, transfer reports, investigation reports, and regulatory documentation.
• Ability to effectively communicate and justify analytical control strategies within cross-functional teams (Quality, Regulatory, Process Development) and with external stakeholders.
• Experience overseeing external partners (e.g., CDMOs) and managing outsourced analytical activities.
• Strong leadership, communication, and project management skills in a cross-functional environment.
• Strong technical writing and authorship skills, with the ability to prepare, review, and approve analytical reports and CMC documentation to support internal decision-making and knowledge management.

Benefits

• Comprehensive health and wellness programs.
• Flexible work arrangements.
• Professional development opportunities.
• Employee recognition and rewards.

Pay

• Manager: $147,341 – 171,488
• Senior Manager: $174,036 – 198,405

Schedule

• Full-time