Lab Manager - MALDI

Lab Manager - MALDI Req ID #:  197813 Location: 

Newark, DE, US, 19711 For 70 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 Summary We are seeking a Laboratory Manager for our MALDI Lab at our Microbial Solutions site located in Newark, DE.  

Manager 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 samples 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, 211 and 820, in addition to ISO 17025 guidelines.  

The following are the duties & responsibilities related to the Laboratory Manager: 

•    Manage activities with utilizing various technology platforms including but not limited to 16s Sequencing, MALDI-TOF Mass Spectrometry and strain typing to ensure optimum performance of the laboratory.

•    Establish and provide continual evaluation of work procedures and processes that support CRL and departmental standard, 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, merit increases and salary reviews.

•    Collaborate with Regulatory Compliance to ensure qualifications, preventative maintenance, repairs, and cleaning processes are performed on all laboratory equipment.

•    Collaborate with Regulatory Compliance and Customer Care to report, record and resolve Out of Specification (OOS) findings, deviations, and customer complaints. 

•    Collaborate with R&D and Process Development Specialists to ensure assay and laboratory improvements.  

•    Collaborate with Customer Care to resolve discrepancies with customer samples.

•    Develop and oversee the implementation of departmental training programs.

•    Assist with the validation and requalification of laboratory equipment.

•    Troubleshoot lab equipment and supporting systems.

•    Provide backup for all laboratory functions.

•    Dispose of microbe cultures, chemicals, and glass in proper waste containers.

•    Comply with all aspects of laboratory safety, safety stations, safety manuals, safety SOP, and MSDS/SDS sheets.

•    Provide support for regulatory agencies as required

•    Perform all other related duties as assigned. Job Qualifications

The following are the minimum qualifications related to the Laboratory Manager:  Education: Bachelor’s degree (B.A./B.S.) or equivalent in Microbiology or related discipline. Experience: 6 or more years’ experience in Molecular or Microbiology laboratory. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Certification/Licensure: None. Other: Working knowledge of the quality system.

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 17,000 employees within 90 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 ~85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

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 crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

Nearest Major Market: Philadelphia

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