Associate Director Accugenix Operations

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.

Job Overview

Oversee 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 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.).

Compensation Data

The pay rate for this role is $135,000 - $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

About Microbial Solutions
Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.

At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in the last five years.

We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to View email address on click.appcast.io. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

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