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 Summary Responsible for the management of a team dedicated to scientific development and assay optimization as it pertains to the Virology laboratory. Will provide operational supervision, technical support and professional and scientific expertise, as needed, to ensure operational excellence.ESSENTIAL DUTIES AND RESPONSIBILITIES:
Planning and ensuring on-time delivery of client projects.
Lead the development, qualification and validation of new assays that meet industry expectations and current regulatory guidelines. As Virology Subject Matter Expert, provide guidance for resolution of technical problems affecting Virology assays.
Oversees the optimization of existing Virology assays and their life cycle management, which will include monitoring to assess the need for subsequent requalification.
Support and manage the technical transfer of in vitro Virology assays.
Work with Sales to identify and fill gaps in Virology testing.
Partner with Business Development in providing and reviewing pricing and proposals, and provide excellent service to clients.
Act as a liaison with other departments to ensure that any method development appropriately aligns with Virology processes and subsequent routine testing.
Supports other operational areas in relation to virus based work, as needed, by providing guidance for R&D.
Participate in client technical calls to assist with Virology assay development or trouble shooting.
Supervise technical staff and perform personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions, time and vacation approval and preparing and delivering annual performance and salary reviews.
Develop and maintain departmental systems and SOPs. Maintain compliance of operating documents through review and revision as required by SOPs. Assist in the development and communication of departmental policies and procedures.
Participate in and support cross-functional communication and laboratory activities, as necessary.
Assist in the development of the departmental budget, including resource allocations and needs, and authorize expenditures.
Ensure adherence to pertinent regulatory requirements and to departmental policies.
Perform all other related duties as assigned.
With respect to all Virology assays and tests, the manager assures that:
Study or assay protocols are approved as provided by applicable regulatory requirements and that the protocols are followed.
All experimental data, including unanticipated observations, are accurately recorded and verified.
Unforeseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented.
Test systems, including reagents, live cells, equipment or other materials are as specified in the protocol.
All applicable good laboratory or manufacturing practice regulations are followed, as applicable.
All raw data, documentation, protocols, specimens, and final reports are transferred for archiving during or at the close of the study.
Job Qualifications Education: Bachelor's degree or equivalent in biology or a related discipline. Master's degree preferred.Experience: Minimum of 4-5 years related laboratory experience in Virology or related field.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: Demonstrated leadership skills required. Working knowledge of cGMPs or regulatory requirements pertaining to the pharmaceutical and biotechnology industries required.PHYSICAL DEMANDS:
May have exposure to potential chemical, electrical, biological and waste-handling hazards.
Must regularly operate a computer and other office machinery (i.e., calculator, copy machine, and computer printer).
Regularly moves about to access file cabinets, equipment, and personnel.
Ability to observe laboratory test results using a microscope to differentiate shapes, colors and other qualitative properties.
WORKING ENVIRONMENT:
General office and laboratory working conditions.
Laboratory working conditions may occasionally require wearing personal protective equipment, including but not limited to: goggles, face shield, surgical mask, cap, gloves, scrubs and/or shoe covers.
Work with or near toxic or caustic chemicals and biological agents including potential biohazards. Possible exposure to fumes or airborne particles.
Compensation Data The pay range for this position is $105,000-$110,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.Competencies
Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.About Biologics Testing SolutionsWith more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.About Charles RiverCharles 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 over 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.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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past 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 OpportunityCharles 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 crrecruitmentUS@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.225753
