Principal Scientist, BioPhysical

Serve as the Principal Scientist responsible for the development and execution of highly complex method development and characterization studies related to the testing, characterization, and analysis of glycoproteins/biotherapeutics using biophysical instrumentation and methodologies. Independently responsible for conducting and guiding method feasibility, development, optimization, method transfers, qualifications, and ICH validations, and for conducting routine testing in both R&D and cGMP environments. Responsible for guidance and oversight of Jr. Staff performing same. Additionally, will be responsible for management of projects including client interaction, interpretation and reporting of data for assigned research projects. May be responsible for oversight of Laboratories and Scientific staff.

• Functioning independently as the Principal Scientist and technical expert on highly complex studies, develop, perform, and troubleshoot laboratory experiments, tests, and procedures within accepted regulatory compliance for the characterization and analysis of biotherapeutics through use of biophysical instrumentation and methodologies.
• Generate and finalize high quality method and study protocols for sponsor and internal method characterization and sample testing programs. Ensure that study protocols are amended to accurately reflect any changes in scope of work or deliverables, in a timely fashion.
• Function as the primary contact for the planning and execution of Sponsor interaction related to proposal management, research, and method development, and for the design, scheduling, conduct and reporting of studies.
• Provide oversight of laboratories and mentor and/or supervise scientific staff in the development and execution of studies to generate high quality scientific data within accepted regulatory compliance.
• Provide mentoring and technical guidance to resolve challenges in a timely fashion.
• Implement techniques to improve productivity, increase efficiencies and maintain laboratory state-of-the-art practices.
• Perform routine testing in techniques such as the following with a high degree of reliability, efficiency and accuracy
• 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)

• Education: Bachelor's degree (B.A./B.S.) or equivalent in a Chemistry/Biotechnology or related scientific discipline. M.S. or Ph.D. preferred.
• Experience: At least seven (7) years of relevant experience within a contract research, academic or pharmaceutical industry, including experience in the core competencies of characterization and analysis of biotherapeutics.
• Certification/Licensure: None
• Other: Demonstrated knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred. Ability to work on problems of moderate scope where analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Demonstrated ability to operate typical laboratory equipment, specifically HPLC, AUC, DSC, FTIR, DLS, Spectrometers and other laboratory equipment required. Ability to handle multiple projects, prioritize work and meet deadlines within a cGMP environment. Capable of data interpretation of basic characterization and analysis of biotherapeutics (glycoproteins and peptides) using biophysical laboratory tools and methodologies. Capable of anticipating and recognizing potential problems. Demonstrated independent analytical and problem-solving abilities. Must possess excellent interpersonal skills to maintain communication across functional groups. Ability to collaborate effectively within a group environment. 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.

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.

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 20,000 employees within 110 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 86% of the drugs approved by the FDA in 2021.

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status. 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.