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20 days old

Reagent Technology Project Manager (Diagnostics)

Kelly Services
West Caldwell, NJ 07007
**We are Kelly Science and Clinical** **,** the second largest scientific staffing firm in the U.S. serving 90% of Fortune 100 companies. We have partnered with a proven, stable, growing diagnostic product and separation technology Company that has been in business for over 50 years. Their products have been used in clinical laboratories globally for a wide range of diagnostic applications. Our client is also a preferred supplier of all the worlds leading vaccine manufacturers that provide the production capacity necessary to cope with possible pandemics.


**Job Title:** **Reagent Technology Project Manager (Diagnostics)**


**Overview:**


Our client is a leading provider of clinical diagnostic instrumentation and reagents to the medical community, specializing in the Physician Office Lab, Biopharmaceutical Research and Veterinary Lab markets. Company culture is highly pro-employee with a relaxed and friendly working environment offering a work-life-balance and career growth. Company is immediately seeking a Reagent Technology Project Manager - (Diagnostics) who will be responsible for managing the processes that bring new products to market by acting as a technical expert for current and strategic business opportunities. Duties include clinical trial and project management, writing and executing experimental protocols, reporting experimental data to ensure technical accuracy, profitability and compliance to company and regulatory requirements.


**Responsibilities may include (but are not limited to) the following:**


+ Develop, verify and validate products/instruments/methods/procedures for the evaluation and quality control of reagents, systems, and instrument platforms from inception to launch.

+ Ensure technical accuracy and relevance of all new reagents, systems, and platforms.

+ Manage clinical trials for validating the performance of new products.

+ Identify deficiencies, research and recommend solutions to improve product and business performance, reliability, safety and profitability.

+ Participate in reagent development efforts to increase reagent menus for current and new platforms; work with and manage interdisciplinary project teams to bring new reagents/instruments to market.

+ Streamline processes and written procedures for use internally and in the field, so that new product development is done efficiently.

+ Represent Reagent Technology to ensure adherence to product quality and procedures when outside laboratories perform testing. Manages and drives assigned and special projects to on-time, on-budget, on-quality and on-specification completion.

+ Manage outside validations on products at customer sites per protocol. Manage the study process from contact to completion. Ensure all materials are available for the studies to be performed. Compile, process and report all data collected.

+ Assist in writing and reviewing all FDA 510(k) regulatory submissions for new reagents and/or systems. Assist in data compilation, review and collation for these submissions and summarizing data and conclusions.


**Education/Experience Requirements/Competencies** **:**


+ Legally authorized to work in the job posting Country.

+ Bachelor of Science in Biology or related discipline **OR** Certified Medical Technologist (ASCP) is required.

+ At least 5-7 years of clinical chemistry and project management experience in the in vitro diagnostic industry is required. Hospital or Reference Lab experience and invitro diagnostics (IVD) experience is also required.


**Generous Compensation and Benefits Package "EOE including Disability/Vets**


**\#TJP2021_SPEC**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-08-27 Expires: 2021-09-27

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Reagent Technology Project Manager (Diagnostics)

Kelly Services
West Caldwell, NJ 07007

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