Location: Wayne,PA, USA
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 Summary
Perform routine analytical methods independently as specified in standard in-house SOPs, Client Test Methods and other written procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Independently perform laboratory activities including but not limited to reagent preparation, laboratory cleaning, maintenance/monitoring of laboratory equipment, routine testing of client samples, and generation of routine cGMP and R&D reports.
* Develop understanding of processes and procedures used within the analytical department with a specific focus on Routine Testing and advanced Routine Testing Procedures. This includes understanding of sample type, purpose of test selection, necessary supplies and documentation expectations as well as developing the ability to trouble shoot and problem solve with scientific guidance.
* Demonstrate proficiency in performing the Basic Routine testing offerings as identified below:
o Appearance
o Endotoxin
o HIAC
o Karl Fisher
o Osmolality
o PH
o SoloVPE
* Become proficient in performing at least 2 Advanced Routine Testing offerings which include but are not limited to:
o SDS Page
o Native Page
o HPLC Methods
o Elisa Methods
o N-Terminal Sequencing
* Develop and Maintain excellent pipetting skills as listed below:
o Single Pipetting
o Multichannel pipetting
* Analyze data and report results of experiments and procedures.
* Competently perform peer review of data
* For cGMP and R&D 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 and procedures. Actively participate in laboratory maintenance.
* Comply with all pertinent regulatory standards regarding environs, equipment and testing services.
* Perform assay and equipment troubleshooting under guidance from senior members of the group.
* Make detailed observations and maintain clear, detailed, accurate and timely documentation of all laboratory work.
* Independently compose high quality documentation including deviation reports and change control documentation. .
* Review and edit SOPs, protocols and testing documentation.
* Follow all SOPs, CTMs and cGMPs as they relate to specific tasks.
* Assist in training 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 assigned.
Job Qualifications
* Education: Bachelor's degree (B.S.) or equivalent in biochemistry, chemistry or related discipline.
* Experience: 1 to 3 years related industry experience in an analytical science area in the Pharmaceutical, Biotech or contract laboratory (CRO) environment.
* An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
* Other: Knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred. Knowledge of basic protein /peptide analytical techniques and ability to operate typical laboratory equipment, specifically HPLC, Plate Reader, CE, spectrophotometer and other laboratory equipment required. Strong organizational and prioritization skills required. Attention to detail and accuracy a must. 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. Basic Microsoft Office skills are required. Ability to understand and use internal software programs such as LIMS required.
* Able to communicate effectively in a small group or one on one setting. Basic Microsoft Office skills are required
Compensation Data
The pay range for this position is $26.55 per hour. 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 supported the development of 86% of the drugs approved by the FDA in 2021.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
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 ...@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.
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