Director, Diagnostic Assay Development

About the job:

Amprion is a growth-stage diagnostics company enabling precision medicine for people with neurodegenerative disorders. Delivering on this goal requires solving hard problems and we need talented, passionate people to help us help patients. Working at Amprion means contributing to our mission to facilitate the end of Alzheimer’s, Parkinson’s, and other neurodegenerative disorders through early diagnostic testing.

Position Summary:

The Director, Diagnostic Assay Development will be responsible for defining and leading all aspects of diagnostic assay development from initial introduction (i.e., transfer from R&D or other source) through optimization, validation, and transfer to production. Reporting to the VP, Clinical Operations, this role will enable the launch of new clinical diagnostic assays for neurodegenerative disorders.

Responsibilities:

·      Plans, designs, and executes analytical experiments and develops methods through all stages/phases of design, development, and the assay life cycle

·      Prepares and reviews documents associated with all phases of Design Control

·      Provides expertise in stability studies

·      Supports the clinical diagnostic laboratory in the design and implementation of appropriate assay controls

·      Ensures transfer to laboratory operations using good laboratory practice and alignment with CAP/CLIA

·      Troubleshoots and optimizes assay components and workflows

·      Contributes expertise to instrumentation, data interpretation, and reporting

·      Represents the development team in all meetings on product development and provides guidance to ensure success of product launch

·      Creates and contributes to the preparation and review of SOPs, forms, or other laboratory documentation requirements

·      Interacts with laboratory and executive management in communicating project status and resourcing

·      Provides oversight and direction to direct reports, as applicable

·      Performs other duties as required

Requirements:

·      PhD with a minimum of 8-10 years of experience in molecular biology, biochemistry, chemistry, or related field

·      Minimum of 5 years in a leadership/management role

·      Extensive experience in diagnostic assay development of chemistry or molecular-based platforms in a variety of matrices (i.e., CSF, skin, blood)

·      Experience with seed amplification assays preferred

·      Strong knowledge of US and EU diagnostic regulations

·      Demonstrated technical expertise and innovation via publications and product launch

·      Strong analytical and critical thinking skills

·      Strong leadership capabilities and the ability to lead multiple concurrent projects

·      Excellent written, oral, and collaboration skills

Work Environment:

Clinical laboratory and office space

Physical Requirements:

While performing the duties of this job, the employee is regularly required to sit, talk, hear, and operate equipment and a computer. The employee is occasionally required to stand, walk, and use hands and arms to lift and/or move up to 10 lbs. Specific vision abilities required by this job include close vision and the ability to adjust focus.

In this work environment, the employee is occasionally exposed to moving mechanical parts, unpleasant odors, and loud noises. Interaction with laboratory equipment, samples, supplies, and laboratory personnel may be required, whereby appropriate precautions are to be taken per the company’s