Senior Director, Analytical Sciences

Scorpion Therapeutics

United States

Remote

USD 230,000 - 320,000

Full time

6 days ago
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Job summary

Mineralys Therapeutics seeks a Senior Director of Analytical Sciences to provide strategic and technical leadership for analytical development across the small molecule portfolio, from development through commercialization. The role involves lifecycle oversight, cross-functional partnership, and strategic direction for impurity control and regulatory readiness.

The position emphasizes external collaborations, strong communication, and leading a growing team in a fully remote setup with

Qualifications

  • PhD in Analytical Chemistry or related field with 15+ years in pharma/biotech leading analytical sciences.
  • Deep expertise in analytical method lifecycle, validation, impurity control, and cGMP compliance.
  • Proven experience with external partnerships and global regulatory environments.
  • Excellent communication skills.

Responsibilities

  • Lead phase-appropriate analytical strategies and lifecycle management for small molecule programs.
  • Oversee method development, validation, transfer, impurity control, and regulatory support.
  • Manage external CRO/CDMO partnerships and regulatory audits.
  • Drive analytical readiness for process validation, launches, and post-approval changes.
  • Collaborate across CMC functions and manage budgets, timelines, and team growth.

Skills

Analytical leadership
cGMP compliance
Regulatory strategy
External partnerships
Effective communication

Education

PhD in Analytical Chemistry

Job description

Role: Senior Director, Analytical Sciences — provides strategic and technical leadership for analytical development supporting Mineralys' small molecule drug substance and drug product portfolio, from development through commercial lifecycle.

Responsibilities
  • establish phase-appropriate analytical strategies, lead method development, validation, transfer, and lifecycle management; oversee specifications, impurity control, stability, and regulatory support; manage external analytical partners including CDMOs and laboratories; author regulatory documents and support audits; drive analytical readiness for process validation, launch, and post-approval changes; partner cross-functionally across CMC functions, manage budgets, timelines, and team growth.
Requirements
  • Ph.D. in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field; 15+ years in pharmaceutical/biotech industry with progressive leadership in analytical sciences, supporting small molecule development through regulatory approval and commercialization; deep expertise in analytical method lifecycle, validation, impurity control, and cGMP compliance; proven experience in external partnerships and global regulatory environments; excellent communication skills.
Preferred
  • experience with oral solid dosage forms, late-stage development, process validation, and establishing scalable analytical functions; background in virtual or outsourced models is advantageous.
Work Setup
  • fully remote; travel up to 10%, often outside local area.
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