Laboratory Manager

Job Summary:

The Laboratory Control (LC) Manager oversees the duties and functions in the laboratory control system and ensures testing and other responsibilities are conducted timely and accurately within a GMP aseptic fill manufacturing facility. Responsible for managing the department and its employees including hiring, training, and coaching employees in accordance with company policies and procedures and will ensure that work is properly allocated and completed in a timely and accurate manner.

Job Scope:

The Laboratory Control System is one of six quality systems. The LC Manager will work directly with the Vice Presidents, system managers, and supervisors. The LC Manager is required to collaborate, understand, and be familiar with other systems’ functions and procedures; with a key role in product and analytical method development. As a key member of the Nova-Tech Management Team, support and assist with the development of the direction, goals, and objectives of the company in order to provide the best quality product and excellent customer care.

Responsibilities:

·        Subject Matter Expert of LC standard operating procedures (SOP) and forms; responsible for establishing and revising these documents

·        Supervise, train, delegate, and back up responsibilities and workloads of LC Technicians

·        Complete LC System employee’s disciplinary documentation and performance evaluations

·        Recommend the hiring, firing, advancement, promotion or any other change of status of LC System employees to Human Resources

·        Responsible for component, in-process material and finished drug product testing, and process monitoring

·        Analyze and recommend instrument and method assessment to management

·        Develop, validate, and implement test methods for new and existing material and products

·        Set and revise raw material, in-process material, and finished product specifications

·        Manage drug product stability program

·        Review trending, make recommendations, and take actions

·        Source, maintain, and order laboratory supplies

·        Manage miscellaneous testing and carry-through assigned projects i.e. pre-shipment samples, pH adjustment, and testing of vendor approval

·        Shared cleaning of the Administration and Laboratory areas

·        Other duties as assigned

Qualifications

·        Familiar with USP

·        Experienced in analytical method development, validation, and associated method transfer 

·        Working knowledge of CGMP, preferably in the pharmaceutical area

·        Working knowledge of laboratory equipment and ability to identify and make recommendation for purchase

·        Detail and goal oriented with organizational skills and ability to multi-task and meet deadlines

·        Critical and systematic thinking and problem solving skills

·        Good composition, data input, and analysis skills

·        Able to lift 30-50 lbs.

Minimum Education and Experience:

·        BS graduate with background knowledge in natural science curriculum, chemistry and/or biology preferred. Physical and life science is a plus. 

·        Three years of supervising experience in a regulated industry

·        Ability to read, write, speak, and understand English sufficiently to perform the duties of this position.