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Manager, Necropsy-Req. 53531 at Charles River Laboratories

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Employer: Charles River Laboratories – Safety Assessment

Expires: 03/31/2020

Job Title: Manager, NecropsyFor 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.BASIC SUMMARY: Oversee activities of the laboratory to include administrative tasks, meeting financial objectives, meeting study milestones, training, and coordinating activities between the laboratory and other groups within and external to the pathology department. Assist in the development and recommendation of departmental budget. ESSENTIAL DUTIES AND RESPONSIBILITIES: ·       Ensure compliance with SOP’s, GLP’s, and H&S and department policies/procedures·       Ensure sufficient and appropriate resources (personnel, equipment, etc.) are available to perform laboratory procedures.·       Manage activities of the laboratory to include administrative tasks, meeting financial objectives, meeting study milestones, and training, coordinating activities between the laboratory and other groups within and external to the pathology department.·       Responsible for coordination, planning and scheduling of laboratory projects.·       Oversee departmental procedures for sample receipt, handling, tracking, transfer, shipping, etc.·       Manage activities of assigned group(s) to ensure effective performance of function.·       Interview and participate in the selection of qualified exempt- and non-exempt level departmental personnel. Recommend, review and approve personnel actions, including hiring, promotions and raises. Partner with Human Resources in the handling of disciplinary issues. Prepare and/or approve appropriate personnel action paperwork. ·       Identify training and development needs of direct reports. Develop and oversee the implementation of departmental training programs, including orientation; monitor training programs to ensure ongoing effectiveness.·       Monitor performance of direct reports. Provide regular coaching and counseling. Prepare and deliver salary and performance reviews; review and approve performance and salary appraisals initiated by direct reports.·       Authorize overtime as needed. Review and approve time cards of direct reports. Review and approve vacation/time off requests and coordinate vacation/time off schedules.·       Oversee the development of short- and long-range operating objectives, organizational structure, and staffing requirements. Assist in the development of a departmental plan for backup and succession of supervisory staff and key technical personnel.·       Ensure optimum performance of group function. Determine and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.·       Develop and maintain departmental systems and SOPs. Assist in the development and communication of departmental policies and procedures. Partner with Human Resources to develop and approve job descriptions for subordinate positions; ensure communication of duties and responsibilities to employees. ·       Assist technical staff as needed in all laboratory tasks to ensure timely completion of study related activities.·       Assist in the development and recommendation of departmental budget. Authorize expenditures in accordance with budget. Approve budget and expenses of subordinates.·       Perform all other related duties as assigned.QUALIFICATIONS:·       Education: Bachelor’s degree or equivalent in a biological science preferred.·       Experience: 5 year of pathology laboratory experience. Previous experience supervising and/or managing a laboratory under GLP regulations is required.An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.Placement at this level requires successful completion/competency of the required tasks of the position(s) preceding this level and continued ability to perform those tasks are required…·       Certification/Licensure:  None·       Other: Must be able to perform effectively as a team member, accurately record data, follow verbal and written instructions, maintain a positive work atmosphere, communicate effectively, and interact in a professional manner with management, coworkers, and sponsors. Experience with computer software programs is required.PHYSICAL DEMANDS:·       Employees must be able to lift, move, manipulate, and/or hold heavy objects up to and including 50 pounds; this includes work materials, equipment, and/or animals.·       Must be able to perform laboratory procedures, which require, talking, hearing, standing or sitting for long periods of time, entering data into a computer, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards.·       Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.WORK ENVIRONMENT:·       Works in a research laboratory environment, which requires use of sharp objects, working around mechanical parts, working with or near known or unknown toxic or caustic chemicals and/or biological hazards, exposure to fumes and airborne particles, working at noise levels ranging from quiet to moderately noisy.Comments:·       This position may require occasional domestic travel. May work occasional weekends and/or holidays.Job Summary Designs and/or executes toxicology testing strategies and studies. Provides guidance to Sponsors regarding study design and study endpoints. Writes study protocols and plans. Leads and is responsible for all aspects of the study including in-life, data review and interpretation, communication of results to Sponsors, study updates to the Sponsor, and the draft and final reports. Ensures that all Principal Investigators, Individual Scientists, and all key study personnel are held accountable for the various study components. Ensures compliance with protocols/study plans, applicable SOPs and BOPs, and regulatory guidance documents. Troubleshoots and resolves study issues. Provides advisory functions to clients designing a program or experiment, dealing with specific dataset interpretation, or when appropriate answering questions from regulatory authorities.The following are responsibilities related to the Manager Necropsy position:The following are minimum qualifications related to the Manager Necropsy position:About Safety Assessment Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.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 14,000 employees within 80 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 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.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 2018. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity Employer – M/F/Disabled/Vet