Senior Manager Analytical Services

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

Manage laboratory personnel and all activities related to Analytical testing for Charles River Laboratories PA-Biologics.

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for daily laboratory activities and laboratory scheduling.
• Ensure appropriate training of the technical personnel in general laboratory skills; reinforce regulatory concepts (cGMP) and Analytical-specific laboratory techniques.
• Perform technical troubleshooting with staff as needed.
• Ensure assays meet regulatory guidelines and expectations.
• Support the customer service and sales departments.
• Support validation of new assay formats as well as re-validation of existing assays.
• Document revisions to ensure the analytical laboratories maintain compliance status.
• Manage activities of assigned group(s) to ensure effective performance of function.
• Interview and select 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 submissions. Review and approve vacation/time off requests and coordinate vacation/time off schedules.
• Assist in the development of short- and long-range operating objectives, organizational structure, and operational requirements. Assist in the development of a departmental plan for backup and succession of supervisory stall and key technical personnel.
• Assist in the development and recommendation of departmental budget. Authorize expenditures in accordance with budget. Approve budget and expenses of subordinates.
• Performs other related duties as assigned.

With respect to all assays and tests performed in laboratories they manage, the laboratory manager assures that:

•

• Study or assay protocols, including any changes, are approved as provided by applicable regulatory requirements, and that the protocols are followed.
• All experimental data, including observations of unanticipated responses of the test system, 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 material 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.

QUALIFICATIONS:

• Education: Bachelor's degree (B.A./B.S.) or equivalent in biology or related discipline; Master's degree preferred.
• Experience: 7-9 years related experience in a laboratory. 3+ years supervisory experience required.
• Certification/Licensure: None.
• Other: Demonstrated leadership skills required. Working knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biotechnology industries required.

Compensation Data

The pay rate for this role is $115,000 - $130,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

About Biologics Testing Solutions With 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 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 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 Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

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 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.