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Manufacturing Associate I - Plasmids

Charles River Laboratories International Inc (CRL)

Rockville, MD, US, 2085

Manufacturing Associate I - Plasmids Req ID #:  178111 Location: 

Rockville, MD, US, 20850 Rockville, MD, US, 20852 Rockville, MD, US, 20850 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. Job Summary  

As a member of plasmid manufacturing team, the Manufacturing Associate I applies a broad knowledge of biological, bioprocess, and mechanical principles to execute manufacturing protocols in a regulated and controlled environment. Performs in-process analysis of plasmid production. 

 

Duties and Responsibilities 

  Perform basic upstream activities in seed train, bioreactor set up, fermentation monitoring, and harvest  Perform basic downstream activities such as cell lysis, chromatography, TFF, and final formulation steps  Perform in-process plasmid analysis  Document of all activities in Batch Records, Logbooks, Forms, etc.    Follow verbal and written procedures in operating production equipment and performing processing steps accurately. Timely completion of appropriate production documentation  Exercise basic problem-solving skills and reporting observed process variances that deviate from normal operation to senior members of group in a timely manner  Participate as needed in process investigations to determine root cause and effect for process deviations  Monitor processes using automated production systems and controls under the guidance of manufacturing associate II or III  Prepare, sanitize, and disinfect equipment to prevent microbial contamination  Demonstrate ability to troubleshoot basic mechanical operations with input from senior manufacturing associates  Operate upstream/downstream process equipment, perform process methods, and prepare buffers with supervision  Ability to operate process equipment, perform laboratory procedures, data analysis, and complete documentation with training  Responsible for documenting in real time process steps in batch records/work instructions and submitting completed documents to Manufacturing Associate II/III for review.  Responsible for collecting and storage of in-process and final bulk product samples as per current manufacturing procedures  Other responsibilities as needed  Job Qualifications

  B.S. in Science or Engineering with < 1 year experience in a Biotech or related industry, or equivalent experience  Basic understanding of purification methods from cell culture processes    Familiarity with the following: Upstream - bioreactors (Wave, BioFlo 120, XDR, and fermenters), Aseptically perform seed and fermenter inoculation, sampling and harvesting. Downstream - column chromatography (Affinity, IEX, HIC), buffer preparation, and Tangential Flow Filtration (TFF)  Able to work under supervision performing basic upstream and/or downstream tasks    Detail oriented with strong organizational skills  Collaborate with Manufacturing Associate II on performance daily tasks. Responsible for the completion of daily tasks as per manufacturing schedule  Previous work in plasmid production desired but not required for position 

Vaccine Mandate

Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19.  Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees. 

Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

 

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 18,000 employees within 100 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 >80% of the drugs approved by the FDA for the past 3 years.

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, 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

Job Segment: Biotech, Engineer, Biology, Pharmaceutical, Science, Engineering, Research

Job posted: 2022-05-10

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