Research Associate I, Bioassay

For 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.

Basic Summary

We are seeking a Research Associate I for our Biologics site located Shrewsbury, MA.

ESSENTIAL DUTIES AND RESPONSIBILITEIS:

• Independently perform laboratory activities including but not limited to reagent preparation, laboratory maintenance/monitoring of equipment, routine testing of client samples, and the generation of routine cGMP and R&D reports
• Perform a variety of analytical laboratory experiments, tests and procedures following well-defined techniques and guidelines, including:

o Routine compendial (USP and Non-USP) testing offerings

o Demonstrated proficiency in a minimum of 2 Advanced Routine Testing offerings, such as:

 Cell culture and cell handling

 ADC, ADCC, CDC assays

 Potency assays

 ELISA/ Immunoassay Analyses

 Aseptic Techniques

• Excellent pipetting skills as listed below:

o Single Pipetting

o Multichannel pipetting

o Repeat Pipetting

o Reverse Pipetting

• Make detailed observations and accurately and precisely record data. Summarize data for complex reports.
• Troubleshoot unexpected/invalid results, prioritize workload and solve moderately complex problems.
• Prepare Excel or Word tables for data evaluation.
• Provide peer review and technical review of documents, reports and data.
• For both cGMP and R&D grade routine testing, generate analytical data and technical report(s) on-time with respect to internal and client deadlines. Maintain a weekly schedule to ensure all timelines are met.
• Actively participate in laboratory instrumentation and equipment preventative maintenance and qualification programs.
• Perform assay and equipment troubleshooting with minimal guidance from senior members of the group.
• Independently compose high quality documentation including deviation reports and change control documentation with no/minimal guidance.
• Participate in client/sponsor relationships (e.g. technology transfer, conference calls and sharing of technical information).
• Create, review and edit SOPs, protocols and other data forms and testing documentation.
• Perform all other related duties as required.
  

MINIMUM QUALIFICATIONS:

• Bachelor's degree (B.S.) or equivalent in biochemistry, chemistry or related discipline.
• Minimum 2 years related industry experience in an analytical laboratory in the Pharmaceutical, Biotech or contract research laboratory (CRO) environment.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above

Vaccine Mandate
Charles River is a U.S. Federal Contractor. As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021. Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees.

Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

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.