Research Associate I, Analytical

Req ID #:  144151
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

Perform compendial and routine analytical methods, data interpretation and reporting independently as specified in standard in-house SOPs, Client Test Methods and other written procedures. Assist scientific staff on 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 reporting of data for assigned research projects.

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

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

  • Independently perform laboratory activities including but not limited to:
    • reagent preparation,
    • laboratory maintenance/monitoring of equipment,
    • routine testing of client samples,
    • 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: 
    • Routine compendial (USP and Non-USP) testing offerings
    • Demonstrated proficiency in a minimum of 2 Advanced Routine Testing offerings which include but are not limited to:
    • Biologics Chromatography Analyses 
    • Process Related Residuals Chromatographic Analyses
    • Quantitative Monosaccharide and Sialic Acid Analysis
    • ELISA/ Immunoassay Analyses
    • Drug Product Excipient Analyses
    • N- Terminal Sequencing
    • Amino Acid Compositional Analysis/Extinction Coefficient Determination
    • Excellent pipetting skills as listed below:
    • Single Pipetting
    • Multichannel pipetting
    • Repeat Pipetting 
    • Reverse Pipetting
    • Make detailed observations and accurately and precisely record data.  Summarize data for complex reports. 
    • Assist in the monitoring of key project events.
    • Troubleshoot unexpected/invalid results, prioritize workload and solve moderately complex problems.
    • Review departmental procedures for accuracy of scope of work prior to initiation.
    • 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.
  • Maintain a safe working environment by adhering to Company policies or procedures.
  • Actively participate in laboratory maintenance.

ADDITIONAL RESPONSIBILITIES

  • Comply with all pertinent regulatory standards regarding environs, equipment and testing services.
  • Perform assay and equipment troubleshooting with minimal guidance from senior members of the group.
  • Make detailed observations and maintain clear, accurate and timely documentation of all laboratory work.
  • 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. 
  • Follow all SOPs, CTMs and cGMP as they relate to specific tasks.
  • Assist in training of junior staff. 
  • Participate in transferring and training of analytical technical 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
  • Perform all other related duties as required.

 

 

MINIMUM QUALIFICATIONS

  • Bachelor’s degree (B.S.) or equivalent in biochemistry, chemistry or related discipline. 
  • Minimum 3-5 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
  • Demonstrated knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.
  • Able to apply knowledge of analytical chemistry to complex assays.
  • Knowledge of basic protein /peptide analytical techniques.
  • Demonstrated ability to operate typical laboratory equipment, specifically HPLC, Plate Reader, CE, spectrophotometer and other laboratory equipment required.  
  • Demonstrated independent analytical and problem-solving abilities.
  • Must possess excellent interpersonal skills to maintain communication across functional groups.
  • Able to communicate (verbal and written) effectively in a small group or one on one setting.  
  • Computer proficiency in MS Word, Excel, Outlook, instrumentation and analysis software.
  • 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 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. 

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.
  • Occasionally works near moving mechanical parts.
  • Frequently works with biohazards.
  • May be exposed to unpleasant odors.
  • The employee may work with sharp objects (i.e. needles, glass pipettes, pipet tips).
  • The noise level in the work environment is usually moderate.

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.


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 18,000 employees within 100 facilities in over 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. 


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 >80% of the drugs approved by the FDA for the past 3 years.


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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