Senior Assay Development Scientist

About Nuclein:

Nuclein is an Austin-based, private equity funded company working to commercialize a cutting-edge, point-of-care, molecular diagnostic system that has received FDA EUA clearance.

Our vision is to enable simple, affordable, rapid, and accurate disease testing for everyone. We are a dedicated, talented, and diverse team of scientists, engineers, and experienced professionals who are driven to excel and make a significant contribution to the world. At Nuclein, we offer a fast-paced, dynamic, collegial environment, where individual contributions are highly valued.

Position Summary:

The Senior Assay Development Scientist will provide technical leadership and oversight for the company’s commercialization and product development efforts. The individual will work as part of Nuclein’s Assay Development team, reporting to the Vice President of Assay Development. This is an individual contributor role, with opportunity for advancement in line with company growth.

Responsibilities:

• Lead the assay development efforts for the company’s commercialization, and FDA 510(k) submission, initiatives
• Create and execute assay protocols for the development and verification of PCR-based IVD assays
• Work closely with the company’s Research division, providing integration support for new, and existing, assays
• Develop BOMS and handle Design Transfer of assay products to contract manufacturers
• Complete Change Control activities for new products and product changes
• Investigate field and customer complaints for on-market Nuclein assays
• Ensure organizational compliance to 21 CFR 820 and ISO 13485:2016
• Develop and support stability protocols, plans and actions
• Provide mentoring and support to colleagues across the organization
• Provide support for equipment process validations and laboratory compliance
• Support Clinical Trial activities

Qualifications:

• Bachelor of Science degree in Life Sciences or related field required. Masters/Graduate degree preferred.
• 5+ years of experience in IVD assay development and commercialization required. Experience in molecular diagnostic assay development preferred.
• Expertise in DNA, RNA, PCR and general molecular biology laboratory techniques
• Proficient with statistical analysis methods applicable to molecular assay development
• Proficient with 21 CFR 820 and ISO 13485:2016 processes
• Experience in Design Control, Product Verification and Design Transfer
• Good Laboratory Practices knowledge and experience
• Strong Interpersonal skills, both verbal and written