Job OverviewOversee laboratory and data analysis aspects of microbial identification business operations. Direct and monitor operation services in Delaware and responsible for leading the global data review team for the global Accugenix laboratories.
Job DescriptionESSENTIAL DUTIES AND RESPONSIBILITIES: - Manage activities of operation team in Delaware to ensure optimum performance, accurate results, and on-time performance for Accugenix services.
- Direct managers and supervisors (Sequencing, MALDI and Data Analysis) through use of TOC/Lean process improvements to establish standards and metrics for measuring department effectiveness.
- Liaise with R&D, IT and QA for troubleshooting, process optimization, and design and implementation of automation.
- Manage launch of new products and test methods.
- Oversee global Accugenix services data quality management and drive corrective actions as necessary.
- Monitor and report KPIs as required. Utilize performance data to identify and implement process improvements.
- Establish work procedures and processes that support company and departmental standards, procedures, and strategic directives.
- Develop and/or review SOPs, special projects, validation documents, change requests, investigations, and CAPAs in compliance with corporate and site regulations.
- Develop and oversee the implementation of departmental training programs, including orientation.
- Support the set-up, training, and validation of new global Accugenix laboratories and Data Review team.
- Serving as System Owner (SO) for data analysis software and coordinating data analysis software activities.
- Implement continuous improvement methods to enhance area operations, efficiency, and service to both internal and external customers.
- Maintain business fundamental numbers for daily tracking and trending of operations.
- Maintain and recommend improvements for sample tracking databases in accordance with SOPs.
- Manage personnel 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.
- Lead quarterly Accugenix library maintenance and annual library RQ.
- 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.
- 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).
- Perform all other related duties as assigned.
QUALIFICATIONS: - Education: Bachelor's Degree (B.A. /B.S.) in Biological Science or related discipline required. Master's Degree (M.A. /M.S.) is preferred.
- Experience: Ten or more years of experience in Molecular or Microbiology or related field.
- Five years' experience with GMP products preferred.
- Prior experience with laboratory operations and management skills preferred.
- 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 working knowledge of the Quality System. Laboratory and management experience are required. Must have a demonstrated track record of accomplishments with strategy and leadership in operational areas, technical knowledge of business process, implementation of cross-functional projects and TOC/Lean Manufacturing or process improvement techniques. Must be proficient in the use of desktop applications, including the MS Office suite (Word, Excel, etc.).
Compensation DataThe pay rate for this role is $145,000 - $155,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
Physical Requirements 
