Senior Product Stability Specialist
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 an emphasis on assay development and post-launch activities; writes plans and reports; and provides guidance on investigations, test-method development, and validations. The specialist solves complex problems, identifies innovative solutions, and works independently, seeking guidance only in the most complex situations. The position is part of Quality Assurance and Regulatory Affairs NPD at Cepheid in Sunnyvale, California, and is on-site. It reports to the Sr Manager Assay NPD Quality Assurance. The specialist drives assay development and post-launch stability studies, leads process improvements in design control, and leads and coaches colleagues working on assay development or post-launch initiatives. Laboratory work may also be needed.
Requirements
- Bachelor’s degree in a relevant field and 5+ years of related work experience in the medical device or pharmaceutical industry; or a Master of Science 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
- Develop stability strategies for GX assay products, particularly for assay development and post-launch activities.
- Write stability plans and reports.
- Provide guidance for investigations, test-method development, and validations.
- 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 design control.
- Lead and coach colleagues as team members or extended team members in assay development and post-launch initiatives.
- Contribute laboratory work when needed.
Benefits
- Paid time off.
- Medical, dental, and vision insurance.
- 401(k).
- Bonus or incentive pay eligibility.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
