Biomanufacturing Associate II - Downstream

Req ID #:  214263
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 Biomanufacturing Associate II plays an integral role within CRL’s gene therapy manufacturing function by applying biological, bioprocess, manufacturing, mechanical, application, system, and technology principles, processes, procedures, inputs, and outputs, for designated production processes and handovers within a regulated environment to ensure the timely production and release of quality products, based on client specifications. 

This role will apply solid knowledge and experience across a range of tasks, in resourceful and effective ways, requiring good judgment and initiative, when effectively executing manufacturing protocols. 
 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

 

•    Apply and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements. 
•    Effectively execute a range of tasks, in line with SOPs, in one of the following areas: 
o    Downstream Activities (e.g., cell lysis, chromatography purification, centrifugation, Tangential Flow Filtration (TFF), and final formulation steps). 
•    Follow instructions when performing planned manufacturing activities, in alignment with the batch record. 
•    Prepare, edit, and complete quality documents. Well-versed in applying GDP. 
•    Ensure data integrity - accurately document and review work prior to submission.
•    Document, record, investigate, and report observed process variances/deviations, in real time. 
•    Follow instructions when operating equipment. Prepare, clean, and maintain equipment/tools. 
•    Troubleshoot routine issues, using root cause analysis.
•    Propose and implement approved improvements.
•    Create and implement safety practices, assist others, and report all incidents immediately. 
•    Adhere to safe working practices and comply with site-based guidelines by applying: 
o    Cleanroom and aseptic behaviors and procedures. 
o    Proper Personal Protective Equipment (PPE) and gowning requirements.
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    An understanding of biosafety levels and applying specific controls.
o    Universal precautions with respect to OSHA guidelines. 
o    Appropriate organization, sanitizing, and stocking of work area to avoid unsafe situations. 
•    May assist others. 
•    Ensure 100% on time completion of training plan. 
•    Be punctual and flexible with work schedule, tasks, etc. to support business demands. 
•    Perform other responsibilities as required. 

Job Qualifications

 

HS Diploma/equivalent with high grades in science and 3 years of related experience,  A.S. with 2.5 years or a B.S. in biology/life sciences, bioengineering, or related discipline with 1.5 years of experience.

 

Prior cell/gene therapy experience in a technical role covering a range of tasks within a cGMP and/or biotech manufacturing environment or other related industry, etc. Willing to become a qualified LEAN trainer. 

 

Other: 
•    Able to work in accordance with the Charles River Values. 
•    Foster collaboration - is a team player, with a positive attitude, professional tone, and demeanor. 
•    Is accountable and delivers high quality work on time. 
•    Willing to continuously learn and improve.
•    Strong attention to detail, can recognize deviations, and has solid GDP skills.
•    Solid analytical, critical thinking, problem-solving and communication skills. 
•    Solid knowledge/application of Word, Excel, Teams, databases, etc. Willing to learn PowerPoint. 
•    Pass/maintain aseptic/gowning qualifications & media fill activities; work in a cleanroom 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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