(Sr.) Director, Assay Development

IVD Sr Director, quantitative assay development 

Looking for a dynamic assay development role focused in IVD here in San Diego? One of San Diego’s leading biotech companies is looking for a dynamic Director to lead their team. This IVD Director will be responsible for developing and validating quantitative hematology and chemistry IVD assays. This position will lead or contribute to assay protocol development, design, execution and interpretation of validation studies and submission of analytical performance studies to the FDA. This role offers the opportunity to build upon the foundation you’ve already laid in your industry experience and refine your leadership, and assay development skills. 

What you will do:

• Develop and validating chemistry IVD assays to optimize quantitative assay protocols.
• Responsible for verification and validation studies, specific to submission to the FDA for 510(k) clearance
• Contribute to writing, reviewing protocols and study reports

 Who you are:

• PhD preferred, open to BS OR MS Degree with 7 years of experience working on quantitative IVDs
• Expert in hematology or chemistry IVDs
• Track record of working with CLSI standards and delivering analytical performance studies meeting FDA’s expectations
• Working knowledge of GMP, ISO 13485 quality systems, design verification and validation studies, and FDA regulations is required.
• Direct FDA interaction is a must.
• Ideally experience with point of care studies, ideally have gotten CLIA waiver in the past.

What does this position pay?

• Compensation is determined by several factors which may include skillset, experience level, and geographic location. The expected range for this role is $170,000 – $220,000 annually. Please note this range is an estimate and actual pay may vary based on qualifications and experience.

Please email your resume to jhanson@provenrecruiting.com if you’d like to work alongside some of the finest professionals in the Life Sciences industry!

Note: We actively support and promote people of various backgrounds, from race, religion, gender to geographical area, university, lifestyle, and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community. Apply today!

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