For 70 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.
Assist in the development and execution of methods related to the testing and characterization of biotherapeutics using analytical instrumentation and methodologies. Under minimal supervision, may be 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 client interaction, interpretation and reporting of data of assigned research projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- 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.
- Perform routine testing techniques, such as the following, with a high degree of reliability, efficiency and accuracy:
- Chromatographic Analyses including Process Related Residuals
- Quantitative Monosaccharide and Sialic Acid Analysis
- ELISA/ Immunoassay Analyses
- Process Residual/Drug Product Excipient Analyses
- N- Terminal Sequencing
- Amino Acid Compositional Analysis/Extinction Coefficient Determination
- Use of Empower and Chromelion Software
- Review, interpret, analyze, evaluate, integrate and present experimental data with the 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 assistance from Senior personnel.
- Assist in the technical review of procedures and data and documentation.
- Assist in long-term projects (redesign of SOPs, CTMs, basic research procedures or report formats).
- 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.
- 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.
- Maintain a safe working environment by adhering to Company policies or procedures.
- Actively participate in laboratory maintenance.
- Comply with all pertinent regulatory standards regarding environs, equipment and testing services.
- Perform equipment troubleshooting and repair (as applicable) with minimal guidance from senior members of the group.
- Make detailed observations and maintain clear, accurate and timely documentation of all laboratory work.
- Independently compose quality documentation including deviation reports and change control documentation with no/minimal guidance.
- Create, review and edit SOPs, protocols and other data Forms and testing documentation.
- Follow all SOPs, CTMs and cGMP as they relate to specific tasks.
- Assist in training and provide technical support of Junior staff.
- Participate in transferring and training of analytical technical staff on methodology for which qualification has been successfully completed.
- Maintain up to date training records on all procedures and protocols applicable to work duties.
- Ability to work in a structured and regulated environment
- Work productively in group situations as well as independently
- Perform all other related duties as required.
- Bachelor’s degree (B.A. /B.S.) or equivalent in Chemistry/Biotechnology or related scientific discipline. M.S. or Ph.D. preferred.
- Minimum 3 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.
- Demonstrated knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.
- Ability to work on problems of moderate scope where analysis of situation or data requires a review of identifiable factors.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Demonstrated ability to operate typical laboratory equipment, specifically HPLC, Plate Reader, CE, spectrophotometer and other laboratory equipment required.
- Ability to handle multiple projects, prioritize work and meet deadlines within a cGMP environment.
- Capable of data interpretation of basic characterization and analysis of biotherapeutics (glycoproteins and peptides) using analytical laboratory tools and methodologies
- Capable of anticipating and recognizing potential problems.
- Demonstrated independent analytical and problem-solving abilities. .
- Must possess excellent interpersonal skills to maintain communication across functional groups.
- Ability to collaborate effectively within a group environment. Able to communicate (verbal and written) effectively in a small group or one on one setting.
- Computer proficiency in MS Word, Excel, Outlook, instrumentation and analysis software.
- Ability to understand and use internal software programs such as LIMS required.
- Must be able to remain in a stationary position 50% of the time while performing laboratory tasks.
- Regularly observes, inspects, and interprets laboratory experiments, requiring close vision and the ability to adjust focus and detect and differentiate colors.
- Frequently and accurately operate laboratory pipettes.
- Regularly lift and/or move up to 10 pounds and may occasionally lift and/or move up to 50 pounds.
- General laboratory working conditions.
- Regularly wears protective clothing (cap, gloves, scrubs, lab coat, and safety glasses).
- Regularly works with or near toxic or caustic chemicals.
- May be exposed to fumes or airborne particles.
- Regularly works in a chemical fume hood.
- Frequently works with biohazards.
- May be exposed to unpleasant odors.
- The employee may work with sharp objects (i.e. needles, glass pipettes, pipet tips).
- This position may require overtime, weekend, holiday, and/or after hours shift coverage, as needed.
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 17,000 employees within 90 facilities in 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. And in 2019, revenue increased to $2.62 billion.
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 supported the development of ~85% of the drugs approved by the FDA in 2019.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer – M/F/Disabled/Vet.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit www.criver.com.