Manage and develop laboratory staff to ensure effective laboratory operations. Develop and implement strategies to address process improvements. Work with other operations staff to ensure efficient and accurate sample processing to meet customer needs. Ensure that all laboratory functions are carried out within regulatory and GMP guidelines in accordance with 21 CFR parts 210 and 211.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
•Manage activities of sequencing, ribotyping, and process development employees to ensure optimum performance of the group/function.
•Establish and provide continual evaluation of work procedures and processes that support company and departmental standards, procedures, and strategic directives.
•Recommend and implement process improvement methods to improve laboratory operations, efficiency and service to both internal and external customers.
•Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.
•Collaborate with quality assurance to ensure maintenance, repair, and cleaning processes are performed on all laboratory equipment.
•Collaborate with the quality and technical operations teams to report, record, and resolve out of specification findings, deviations, and customer complaints.
•Schedule, direct, track, and document all quality control testing of raw materials and reagents. Ensure quality testing is performed in a timely fashion and designate resources to complete testing.
•Supervise and prioritize work for Process Development Technologist to ensure assay and laboratory improvements.
•Assist in the development of short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
•Assist in the development and recommendation of departmental budget and authorize expenditures.
•Develop and oversee the implementation of departmental training programs, including orientation.
•Support the policy of equal employment opportunity through affirmative action in personnel actions.
•Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
•Provide support for regulatory agencies as required.
•Perform all other related duties as assigned. Qualifications
•Education: Bachelor’s Degree (B.A. /B.S.) in Microbiology or related discipline required.
•Experience: Six or more years related laboratory experience. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•Other: Must have good judgment, excellent communication and diplomacy skills... Must have strong proficiency in all technologies and laboratory techniques. Laboratory management experience strongly preferred.