Position
Manager, Analytical Development and Quality Control
Location: Brisbane, CA (Onsite)
Role Overview: Provides strategic and technical leadership for analytical CMC activities across multiple programs, emphasizing technology transfer, knowledge management, and analytical control strategy.
Responsibilities
* Lead strategic and technical direction of analytical CMC activities.
* Ensure successful transfer of analytical methods and associated knowledge to internal teams and external stakeholders.
* Develop and maintain analytical methods, validation, transfer, and lifecycle management in alignment with ICH guidelines.
* Interpret data from analytical techniques (HPLC/UPLC, GC, KF, ICP-MS, IC, XRPD, PSD) to support technical decisions.
* Develop and communicate analytical control strategies across cross‐functional teams.
* Produce high‐quality technical writing, documentation, and data governance (validation, transfer, investigation reports).
* Coordinate internal teams and external partners, including CDMOs, to support continuous analytical knowledge.
* Provide regulatory support and authoring for INDs, IMPDs, NDAs, and global filings.
* Engage with regulatory agencies regarding NDA submissions.
* Provide leadership, communication, and project management to maintain analytical continuity.
Required Qualifications
* MS in Chemistry, Analytical Chemistry, or related field (8–10+ years experience) or PhD (5–8+ years experience).
* Demonstrated leadership managing analytical CMC activities across multiple programs.
* Strong expertise in analytical method development, validation, transfer, and lifecycle management under ICH guidelines.
* General understanding of key analytical methods and ability to interpret data.
* Experience authoring, reviewing, and approving analytical sections of regulatory submissions.
* Experience supporting NDA submissions and interacting with regulatory agencies.
* Proficient technical writing skills for validation, transfer, investigation reports and regulatory documents.
* Strong communication and justification of analytical control strategies across cross‐functional teams.
* Experience overseeing external partners (CDMOs) and outsourced analytical activities.
* Leadership, communication, and project management skills in cross‐functional environment.
Fit With Nurix Culture and Values
* Team orientation; highly collaborative.
* Solution and result‐oriented focus.
* Hands‐on approach; resourceful and open to diverse points of view.
Salary Range
Manager: $147,341 – $171,488
Senior Manager: $174,036 – $198,405
Equal Opportunity Statement
Nurix is an Equal Opportunity Employer. Applicants must be legally entitled to work for any employer in the US.
#J-18808-Ljbffr