Position Summary:

Manages the day-to-day activities related to the application of reagents and production of test kits, including the direct supervision (training and performance management) of all Production staff. Responsibilities also include developing and implementing policies and procedures, formulating manufacturing operations strategies, and building a team atmosphere by coordinating how Production relates to other departments, such as QA/QC, Technical Operations, Formulations and Assembly.

Duties & Responsibilities:

° Manage all operations involved in the production of diagnostic products, which includes training, retention and performance development of Production personnel through hands-on training, demonstration, and competency skills assessment

° Involved in planning by allocating resources accordingly to assure work is conducted in compliance with manufacturing batch records / quality system requirements, including manufacturing standards.

° Establish and improve procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards.

° Ensure consistent execution according to batch records, and that all Production operations are performed according to established SOPs.

° Communicate with the Head of Laboratory regarding any nonconformance that arise during processing that will impact scheduled product or delivery dates.

° Directly collaborate with the Facilities & Maintenance Manager/ Engineer on all preventative and unscheduled maintenance of equipment performed in the area, in addition to adjustments made to ensure required environmental conditions are met

° Identify, recommend and implement changes to improve productivity, line efficiency, and reduce cost and down time.  Investigate and correct variances in labor and equipment efficiency standards.

° Participate in root-cause investigations related to product problems, lot failures and yield discrepancies and recommending corrective and preventative actions.

° Take an active role in validation protocols for all new equipment and procedures.

Qualifications Required:

°  Bachelors degree or higher in a science related field.

°  Minimum of two years’ experience in the manufacture of diagnostic testing devices.

°  Experience with Microsoft Office applications

°  Excellent verbal and written communications skills

°  Strong technical leadership skills are required.

°  Knowledge of GMP’s, ISO and FDA guidelines related to industry.

°  Knowledge and experience related to process validations.

°  Familiar with OSHA compliance procedures.

°  Familiar with general accounting principles and practices, project management, and general HR practices is a plus.