For nearly 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.
Responsible for providing second shift (4PM to 12:30AM) supervision in the Molecular Biology, Adventitious Agent Detection via PCR Analysis department. Oversees/performs QF-PCR testing while adhering to cGMP requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Schedules, coordinates, performs and supervises daily laboratory activities specific to PCR testing
Provide direct daily supervision and review work of assigned departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices and procedures (SOPs, safety procedures and biosafety protocols).
Author and revise Standard Operating Procedures (SOP), Standard Test Methods (STM), Batch Records (BR) as needed
Author and/or coordinate/contribute to deviation investigations and Corrective and Preventive Actions (CAPA)
Author and/or contribute to change control procedures
Ensures direct reports adhere to company policies and procedures
Ensures analyst compliance to cGMP requirements
Identify training and development needs of direct reports. Assist in the development, implementation and delivery of departmental training programs; ensure that direct reports receive departmental orientation and necessary on-the-job training. Oversee maintenance of group training manual and training records.
Monitor performance of direct reports. Provide regular feedback and progress updates. Assist in preparation and delivery of salary and performance reviews of direct reports.
Clearly communicates goals, objectives and priorities to laboratory analysts
Ensure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
Ensure that departmental equipment is maintained in good working condition and that departmental area(s) are maintained in a clean and orderly condition.
Broad working knowledge of QF-PCR concepts and techniques required
Thorough understanding of cGMP requirements is required
Ability to manage multiple priorities and projects simultaneously
Ability to regularly and clearly communicate testing status to management
BS/BA in science related field preferably in Biology/Molecular Biology
5+ years relevant technical experience and a minimum of 2 years in a supervisory role
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.