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Charles River Laboratories Research Associate 2, Bioassay in Shrewsbury, Massachusetts

Research Associate 2, Bioassay

Req ID #: 104578

Location:

Shrewsbury, MA, US, 01545

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

Under minimal supervision, perform routine bioassay methods, data interpretation and reporting as specified in standard in-house SOPs, Client Test Methods and other written procedures.Independently perform client-specific experimental design, moderately complex professional tasks,report development, quality control, and research. These may include method feasibility,development, optimization, transfers, qualifications, validations and routine testing in both R&D and cGMP environments. Additionally, will be responsible for client interaction, interpretation and reportingof data for assigned research projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Independently perform laboratory activities, including but not limited to reagent preparation, laboratory cleaning, maintenance/monitoring of laboratory equipment, routine testing of client samples, and generation of routine cGMP and R&D reports.

  • Prepare reagents and test samples.

  • Excellent pipetting skills as listed below:

  • Single Pipetting

  • Multichannel pipetting

  • Repeat Pipetting

  • Reverse Pipetting

  • Demonstrate proficiency in performing a minimum of 6 different advanced techniques within the Bioassay department. Techniques may include but not limited to:

  • Cell culture and various cell handling techniques

  • Plate reader platforms (softmax Pro, Tecan Magellan, Biotek Gen-5,

  • Endoscan, and Stegmann PLA)

  • ADC, ADCC, CDC assays

  • Potency assays

  • ELISA/ Immunoassay Analyses

  • PCR

  • Flow cytometry

  • Endotoxin testing

  • Monitor key project events.

  • Make detailed observations and maintain clear, detailed, accurate and timely documentation of all laboratory work. Accurately summarize data for complex reports.

  • Update sample-tracking databases and maintain chemical inventory for the laboratory.

  • Thorough understanding of processes and procedures used within the bioassay department.

  • This includes knowledge of various cell lines, purpose of test selection, necessary supplies and documentation expectations.

  • Prioritize workload and perform assay and equipment troubleshooting independently

  • Review departmental procedures for accuracy of scope of work prior to initiation.

  • Prepare Excel or Word tables for data evaluation.

  • Provide accurate peer review and technical review of documents, reports and data.

  • For both cGMP and R&D grade routine testing, generate data and technical report(s) on-time with respect to internal and client deadlines.

  • Maintain a weekly schedule to ensure all timelines are met.

ADDITIONAL DUTIES AND RESPONSIBILITIES

  • Actively participate in laboratory instrumentation and equipment preventative maintenance and qualification programs

  • Maintain a safe working environment by adhering to company policies and procedures.

  • Comply with all pertinent regulatory standards regarding environs, equipment and testing services.

  • Compose high quality documentation including deviation reports and change control documentation independently.

  • Follow all SOPs, CTMs and cGMP as they relate to specific tasks.

  • Training junior staff on methodology for which qualification has been successfully completed.

  • Maintain up to date training records on all procedures and protocols applicable to work duties.

  • Ability to work in a structured and regulated environment

  • Work productively in group situations as well as independently

  • 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, cellular/molecular biology or related discipline.

  • Minimum 3 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

  • Knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.

  • Knowledge of basic aseptic techniques and cell culture.

  • Strong organizational and prioritization skills required.

  • Attention to detail and accuracy a must.

  • Effective verbal and written communication skills required.

  • Microsoft Office skills are required.

  • Ability to understand and use internal software programs such as LIMS required.

    PHYSICAL DEMANDS:

  • Must be able to remain in a stationary position 50% of the time while performing laboratory tasks.

  • Regularly observes, inspects, and interprets laboratory experiments, requiring close vision and the ability to adjust focus and detect and differentiate colors.

  • Frequently required to walk, sit, stand, reach with hands and arms, and use hands to finger, handle, or feel objects, tools, or controls.

  • Frequently and accurately operate laboratory pipettes.

  • Regularly lift and/or move up to 10 pounds and may occasionally lift and/or move up to 50 pounds.

  • Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.

  • Must regularly communicate with employees; must be able to exchange accurate information.

    WORK ENVIRONMENT:

  • General laboratory working conditions.

  • Regularly wears protective clothing (cap, gloves, scrubs, lab coat, and safety glasses).

  • Regularly works with or near toxic or caustic chemicals.

  • May be exposed to fumes or airborne particles.

  • Regularly works in a chemical fume hood or BSC.

  • May be exposed to unpleasant odors.

  • This position may require overtime, weekend, holiday, and/or after hours shift coverage, as needed.

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 17,000 employees within 90 facilities in 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. And in 2019, revenue increased to $2.62 billion.

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 supported the development of 85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

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.

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