Manager, Analytical Development and Quality Control (Brisbane, CA)
About The Position
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. The position requires deep expertise in analytical method development, validation, transfer, and lifecycle management in alignment with ICH guidelines, along with the ability to interpret data from a range of analytical techniques to support sound technical decision-making. In addition, this role is responsible for establishing and clearly communicating analytical control strategies across cross-functional teams, ensuring alignment and scientific rigor. The Manager drives robust knowledge management practices through high-quality technical writing, documentation, and data governance, including authoring and reviewing validation, transfer, and investigation reports. Strong leadership, communication, and project management skills are essential to effectively coordinate internal teams and external partners, maintain continuity of analytical knowledge, and support informed decision-making.
Requirements
- 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.
- 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.
Nice To Haves
- Fit with Nurix Culture and Values: Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view
Responsibilities
- Provides strategic and technical leadership for analytical CMC activities across multiple programs.
- Ensures successful transfer of analytical methods and associated knowledge to internal teams and external stakeholders.
- Establishes and clearly communicates analytical control strategies across cross-functional teams.
- Drives robust knowledge management practices through high-quality technical writing, documentation, and data governance.
- Authors and reviews validation, transfer, and investigation reports.
- Effectively coordinates internal teams and external partners.
- Maintains continuity of analytical knowledge.
- Supports informed decision-making.
- Oversees external partners (e.g., CDMOs) and manages outsourced analytical activities.
Benefits
- competitive salary
- benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Manager
