Job Overview

Serve as the Principle Investigator/Senior Scientist responsible for the development and execution of highly complex method development and characterization studies related to the testing characterization and analysis of biotherapeutics using analytical instrumentation and methodologies. Independently responsible for conducting and guiding method feasibility, development, optimization, method transfers, qualifications andICH validations, and for conducting routine testing in both R&D and cGMP environments. Responsible for guidance and oversite 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 oversite of Laboratories and Scientific staff.

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Functioning independently as the Principle Investigator/Sr. 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 analytical testing and characterization instrumentation and methodologies.
• Generate and finalize high quality method and study protocols for sponsor and internal 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 analytical challenges in a timely fashion.
• Implement techniques to improve productivity, increase efficiencies and maintain laboratory state-of-the-art practices.
  • Perform routine testing techniques, such as the following, with a high degree of reliability, efficiency and accuracy:
  • 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
  • Use of Empower and Chromelion Software
• Independently review, interpret, analyze, evaluate, integrate, present and discuss experimental data with research staff and Sponsor.
• 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
• Assist in the technical review of procedures and data and documentation.
• Interact with clients regarding project design, scheduling and conduct as requested.
• Collaborate with appropriate departments to coordinate performance of projects, discuss issues and prepare reports.
• Provide scientific and technical leadership within Biologics to resolve analytical challenges in a timely fashion, including research and development of new methodologies in study conduct.
• Manage improvement projects (e.g. redesign of SOP's, research procedures or report formats).
• 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.
• Perform all other related duties as required.

QUALIFICATIONS:

• Education: Bachelor's degree (B.A. /B.S.) or equivalent in Chemistry/Biotechnology or related scientific discipline. M.S. or Ph.D. preferred.
• Experience: Minimum 7 year's relevant experience within a contract research, academic or pharmaceutical industry, including experience in the core competencies of characterization and analysis of biotherapeutics.
• An equivalent combination of education and experience with contract research or the pharmaceutical industry may be accepted as a satisfactory substitute for the specific education and experience listed above.

Compensation Data

The pay rate for this role is $123,000 - $130,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

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.


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