Assay Testing Supervisor
ProterixBio is a small, mission-driven biotech company focused on the development and commercialization of diagnostic tools for the management of pulmonary diseases. Located in Billerica, MA, we are seeking a talented and highly motivated Assay Testing Supervisor to join our team
The Assay Testing Supervisor must be a motivated team-player, be very organized and detail-oriented, be dedicated to performing the highest quality laboratory work and be prepared to learn as well as lead. The role performs duties that include directing laboratory staff to meet testing schedules, ensure adherence to all regulatory requirements, performing data analysis and quality oversight, helping and training laboratory associates, writing and maintaining standard operating procedures (SOPs), organizing and planning future work, and solving and troubleshooting issues as needed.
The Assay Testing Supervisor is the first point of contact for all laboratory testing operations and questions regarding the data generated. This person must be able act independently, be able to analyze and synthesize data, communicate finding and issues, recommend solutions and ideas in a clear, concise, technically proficient and consultative manner.
Duties / Responsibilities:
· Lead a team of laboratory associates in the performance of immunoassay (ELISA) work
· Perform high complexity testing according to established SOPs
· Verify, transfer and validate new assays
· Maintain, update and train staff on laboratory SOPs
· Develop, maintain, and administer laboratory policies, processes and procedures
· Perform proficiency and competency testing for laboratory personnel
· Update and retain regulatory documentation supporting CLIA, OSHA and HIPPA standards
· Maintain accurate records/documentation related to completed work as well as work in progress, analyzed results, quality control testing results and other assigned projects
· Effectively communicate with other team members and management about laboratory operations
· Maintain laboratory equipment and oversee the inventory of testing materials
· Adhere to ProterixBio’s Quality System Management program
· Report all concerns of test quality and/or safety to management
· Undertake special projects, as assigned
· Master’s degree with 2+ years lab experience, or Bachelor’s degree in biochemistry, biology, chemistry or equivalent with 4+ years lab experience
· Experience with immunoassays and automated immunoassay testing equipment
· Experience working in regulated GLP/CLIA or equivalent environment a plus
· Proficiency with Microsoft Office and strong analytical and communication skills
· Experience with kit manufacturing preferred
ProterixBio offers an agile, collaborative work environment. We offer generous benefits that include medical, dental, vision coverage, holiday pay, STD, LTD, life insurance, 401(k) and vacation policy.
ProterixBio is a diverse organization and an Equal Opportunity Employer.
Position requires significant and detailed lab work as well as work under normal office conditions where the individual will walk, stand, stoop, sit, manipulate / adjust items, and keyboard on a regular basis.