Job Overview

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.

Job Description

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. preferred.
• Experience: Minimum 5 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 $107,000 - $115,000 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.

About Charles River
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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.