Associate Director Accugenix Operations

Job Description

ESSENTIAL 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.).