Senior Product Stability Specialist

Danaher Corporation•Sunnyvale, CA

8d•$103,500 - $142,500•Onsite

About The Position

The Senior Product Stability Specialist provides technical quality support throughout the life cycle of GX assay products. The role develops stability strategies, with emphasis on assay development and post-launch activities; writes plans and reports; and provides guidance for investigations, test method development, and validations. The specialist works independently on complex problems, takes a broad perspective to identify innovative solutions, and receives guidance in the most complex situations. The position is part of Quality Assurance and Regulatory Affairs NPD in Sunnyvale, California, and is onsite.

Requirements

Bachelor’s degree in a relevant field and 5+ years of related work experience in the medical device or pharmaceutical industry; or an MS in Life Sciences and 3+ years of relevant professional experience; or a Ph.D. in Life Sciences and 0–2 years of relevant professional experience.
Knowledge of cGMP, ISO, and FDA regulations.
Proficiency in molecular biology techniques, including PCR.
Experience working in cross-functional teams in a global environment.

Nice To Haves

Ph.D. in Life Sciences.
Experience in data handling.
Experience in stability studies.

Responsibilities

Drive assay development and post-launch stability studies, delivering against high-level timelines and maintaining effective cross-functional communication.
Lead process improvement activities, mainly within the design control area.
Lead and coach colleagues serving as team members or extended team members in Assay Development and/or Post Launch Initiatives.
Contribute to laboratory work when needed.
Develop stability strategies and provide technical quality support throughout the GX assay product life cycle.
Write stability plans and reports and provide guidance for investigations, test method development, and validations.