Research Associate I, Biophysical

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

Independently perform routine biophysical methods, data interpretation and report 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 contributing to client interaction, interpretation and reporting of data for assigned research projects.

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, and generation of routine cGMP and R&D reports.
• Perform a variety of BioPhysical laboratory experiments, tests and procedures following well-defined techniques and guidelines, including:

o Analytical Ultracentrifugation (AUC)

o Size Exclusion HPLC-MALLS (SEC-MALLS)

o Differential Scanning Calorimetry (DSC)

o Intrinsic Tryptophan Fluorescence (ITF)

o Fourier Transform Infrared (FTIR)

o Dynamic Light Scattering (DLS)

o Protein Binding via SPR-Biacore

o Circular Dichroism (CD)

• Analyze data and report results of experiments and procedures.
• Make detailed observations and maintain clear, accurate and timely documentation of all laboratory work and 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 detailed and accurate peer and technical review of documents, reports, and data.
• For cGMP and R&D grade routine testing, generate biophysical 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 or procedures.
• Actively participate in laboratory maintenance.
• 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.
• 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 biophysical 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.
• 3-5 years related industry experience in a biophysical science area in the Pharmaceutical, Biotech or contract (CRO) laboratory 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 protein /peptide biophysical techniques and ability to operate typical laboratory equipment, specifically HPLC, spectrophotometer, dialysis/buffer exchange via SPE, and other laboratory equipment a plus.
• Strong organizational and prioritization skills required.
• Attention to detail and accuracy a must.
• Must possess excellent interpersonal skills to maintain communication across functional groups.
• Must have strong written and verbal communication.
• Basic 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 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, safety glasses).
• Regularly works with or near toxic or caustic chemicals.
• May be exposed to fumes or airborne particles.
• Regularly works at a chemical fume hood.
• Occasionally works near moving mechanical parts.
• May work with biohazards.
• Occasionally may be exposed to unpleasant odors.
• The employee may work with sharp objects (i.e., needles, glass pipettes, pipet tips).
• This position may require overtime, weekend, holiday, and/or after hours shift coverage, as needed.

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.