Scientist II - Analytical Services

For 75 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.

Serve as the Scientist responsible for the development and execution of moderately complex testing and characterization of biotherapeutics using analytical instrumentation and methodologies. May be independently responsible for method feasibility, method development, method optimization, method transfers, method qualifications, method validations and routine testing under both R&D and cGMP environments. Additionally, will be responsible for management of projects including client interaction, interpretation and reporting of data of assigned research projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• 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 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 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.
• Perform routine testing techniques, such as the following, with a high degree of reliability, efficiency and accuracy:
  o Chromatographic Analyses including Process Related Residuals
  o Quantitative Monosaccharide and Sialic Acid Analysis
  o ELISA/ Immunoassay Analyses
  o Process Residual/Drug Product Excipient Analyses
  o N
  - Terminal Sequencing
  o Amino Acid Compositional Analysis/Extinction Coefficient Determination
  o Use of Empower and Chromelion Software
• Review, interpret, analyze, evaluate, integrate and present experimental data with minimal assistance of senior technical staff as appropriate.
• 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 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.
• 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.
• 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.…