Senior Manager Analytical Services

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.