Senior Research Associate - Research Analytical Development/Quality Control

Req ID #:  214107
Location: 

Rockville, MD, US, 20850 Rockville, MD, US, 20850

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.

 

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   
 

Job Summary

 

The Senior Research Associate plays a key role CRL’s gene therapy virus production function by independently and effectively applying an advanced knowledge of biological, bioprocess, laboratory, scientific, and mechanical principles, systems and technologies, inputs, and outputs for client studies.
This role will apply in-depth technical knowledge and experience when performing across a broad range of research and laboratory processing tasks, some of which are complex, requiring independent action and initiative in order to design and execute experiments, methods, and tests, and perform smaller studies within a research environment.

 

Key Responsibilities and Duties:

 

• Follow procedures when performing activities, aligned with the mock batch record:
    o Design and execute procedures, tests, and experiments.
    o Assist in developing new methods.
    o Perform small client studies.
    o Set up equipment, prepare media, reagents, pipetting, chromatography techniques, etc.
    o Design and optimize analytical assays, testing and analytical development.
    o Monitor in-process testing.
    o Assist in coordinating and executing daily activities and recordkeeping.
• Apply advanced GDP when preparing, editing, and reviewing working documents.
• Ensure high data integrity – analyze and review work and prepare technical reports.
• Prepare, clean, maintain, inspect, and operate equipment.
• Troubleshoot routine to moderately complex issues, using root cause analysis.
• Co-lead health and safety prevention initiatives.
• Comply with safety regulations and site-based guidelines by applying:
    o Proper aseptic, PPE, and gowning procedures.
    o Proper preparation, disinfection, sterilization, and sanitation methods/processes for equipment, etc.
    o The safe handling, transport, storage, and disposal of biological specimen, chemical, and hazardous materials.
    o Universal precautions/OSHA guidelines.
    o Appropriate organization, sanitizing, and stocking of the work area to avoid unsafe situations.
    o Understanding of biosafety levels and applying specific controls.
    o Assist with safety training.
• Assist, mentor, and train others; share knowledge and best practices.
• Provide recommendations and implement Continuous Improvement/LEAN solutions to create efficiencies.
• Ensure 100% on time completion of own/others training plans; ensure they are maintained and up to date.
• Be punctual and flexible with work schedule, tasks, etc. to support business demands.
• Perform other responsibilities as required.

 

Job Qualifications

 

• HS Diploma or equivalent and 6 years of related experience, A.S. with 5 years, or a B.S. in biology/life sciences, bioengineering, or related discipline with 3 years of related experience.
• Prior cell/gene therapy laboratory experience in a highly technical role covering a broad range of tasks within a bioprocessing, biopharmaceuticals, analytical, product development, and/or cGMP manufacturing biotech environment or other related industry.
• Informal coaching or project management experience desirable.
• Qualified as a LEAN trainer or willing to become qualified.
• Able to work in accordance with and role model the Charles River Values.
• Able to work independently and be a team player, with a positive attitude, professional tone, and demeanor.
• Able to effectively plan, coordinate, and execute multiple projects simultaneously and deliver on time.
• Able to engage and inspire others.
• Demonstrate an operations and customer-focused mindset.
• Willing to continuously learn and improve.
• Strong attention to detail and excellent GDP skills.
• Advanced analytical, critical thinking, and problem-solving skills.
• Takes pride in own work – high quality, delivered on time, requiring limited rework.
• Strong listening, clear written, and verbal communication skills.
• In-depth knowledge/application of MS Word, Excel, PowerPoint, Teams, databases, etc.
• Pass/maintain aseptic/PPE qualifications; work in a laboratory environment for at least 4 hours/day.

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

 
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 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 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.


Nearest Major Market: Washington DC

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