Serve as a Research Scientist responsible for the development and execution of moderately complex research studies related to the characterization and analysis of biotherapeutics. Manage projects, interpret and report data and ensure regulatory compliance of assigned research.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
•Functioning as a Research Scientist develop, perform, and troubleshoot analytical laboratory experiments, tests, and procedures within accepted regulatory compliance for the characterization and analysis of biotherapeutics, techniques include, but not limited to, electrophoresis (CE, IEF, PAGE), chromatography (HPLC, UPLC, IC), and spectrometry (UV/Vis, Fluorescence).
•Generate draft/final protocols for studies in conjunction with the sponsor and internal departments (research staff, client services, et al.).
•Function as 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.
•Assist in oversight of laboratory and mentor technical staff in the development and execution of studies to generate high quality scientific data within accepted regulatory compliance.
•Implement techniques to improve productivity, increase efficiencies and maintain laboratory state-of-the-art practices.
•Review, interpret, analyze, evaluate, and present data on assigned studies, with minimal assistance from senior scientific staff.
•Perform tabulation and statistical analyses of study data, as required.
•Prepare high quality final reports appropriate for assigned study, including integration of supporting subcontractor(s)’s reports into final reports as required, with minimal assistance
•Ensure that reports, raw data specimens, and supporting study documentation are transferred to the archives at the close of each study.
•Provide scientific and technical guidance within Biologics to resolve analytical challenges in a timely fashion, including research and development of new methodologies in study conduct.
•Manage or assist with improvement projects (e.g. redesign of SOP’s, research procedures or report formats).
•Attend scientific meetings, conferences and training courses to enhance job and professional skills.
•Perform other related duties as assigned.Qualifications
•Education: Bachelor’s degree (B.A. /B.S.) or equivalent in a related scientific discipline. M.S. or Ph.D. preferred.
•Experience: At least five years of relevant experience within a contract research, academic or pharmaceutical industry, including experience in the core competencies of characterization and analysis of biotherapeutics. Also requires a full understanding of GLPs (cGMP preferred), and departmental/company SOPs.
•An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•Certification/Licensure: Appropriate for the area of expertise.
•Other: Experience with characterization and analysis of biotherapeutics (proteins and peptides) is required. Exceptional analytical and problem solving capabilities. Experience with Sponsor interaction and business development. Effective written and verbal communication skills. Ability to manage multiple moderately complex projects, prioritize work, and meet deadlines. Capable of anticipating and recognizing potential problems within programs and effectively communicate alternatives to client’s in a meaningful fashion. Must have proven record of delivering quality service to customers on time and on budget.
Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet