Associate Scientist Process Evaluation

Overview

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

Assist associate scientists or scientists by working independently on client-specific experimental design, moderately complex professional tasks, report development, quality control, and research. May supervise a limited number of employees involved in the research and development of both internal and client testing procedures.

• Provide on-site consultation and support to clients during viral clearance studies.
• Assist scientists to develop chromatographic and analytical techniques.
• Assist in developing and performing validation of new assay formats as well as re-validation of exciting assays.
• Monitor performance of direct reports. Supervise daily laboratory activities to ensure optimum group performance.
• Assist with client communication and project tracking and coordination.
• Efficiently organize and plan daily activities, including activities of less senior departmental technicians. Provide technical guidance and training to less experienced technicians.
• Monitor key project events.
• Execute viral clearance methods and perform laboratory activities necessary for Process Evaluation testing and assays.
• Participate in the validation and qualification of process evaluation assays.
• Make detailed observations and accurately and precisely record data. Summarize data for reports; perform simple graphic analysis of data.
• Assist in the writing of departmental documents and study reports as directed by Assist associate scientists or scientists.
• Review departmental procedures for accuracy of scope of work prior to initiation.
• Prepare Excel or Word tables for data evaluation.
• Provide quality control review of documents, reports and data.
• Maintain a safe working environment by adhering to company policies and procedures.
• Follow all SOPs, STMs and cGMP guidelines as they relate to specific tasks.
• May be responsible for personnel activities such as: scheduling, personnel actions (interview and selection of hires, promotions, transfers, etc.). May assist in training and development, including regular direction, coaching and feedback on performance. May assist in preparation and delivery of performance and development plans and salary reviews. May partner with Human Resources for disciplinary actions. May review and approve recorded working time and vacation/time off schedules.
  
  May schedule overtime as authorized.
• Perform all other related duties as assigned.

• Education:
  
  Bachelor s degree (BA/BS) or advanced degree in biology or related discipline.
• Experience:
  
  5-7 years of related industry experience (pharmaceutical, research laboratory, CRO).
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Demonstrated strong technical writing, oral communication and organizational skills desired. Strong computer skills, problem solving and attention to detail. Must be proficient in the use of current software tools utilized in the Molecular Biology Department, such as Lasergene, Sequence Detection System, Blast, MS-Word and MS-Excel. Familiarity with data management required. Able to work independently with minimal supervision.

The pay rate for this role is $84,000 - $90,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

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.

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.

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…