Senior Scientist 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.

** 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 Chrome lion 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)…