Senior Director, Analytical Sciences

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.

• 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.

• 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.

• experience with oral solid dosage forms, late-stage development, process validation, and establishing scalable analytical functions; background in virtual or outsourced models is advantageous.

• fully remote; travel up to 10%, often outside local area.