Upstream Bio Process Associate I, MSAT

Upstream Bio Process Associate I, MSAT Req ID #:  141031 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.

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 Bioprocess Associate I, Upstream, MSAT, will transfer product and process knowledge between development and manufacturing to ensure right-first-time clinical and commercial manufacturing and continuous improvement. Those processes include buffer and media preparation, upstream, and aseptic fill-finish.

Duties and Responsibilities

•    Interact with Process Development (PD), GMP Manufacturing, Facilities, Quality Control (QC), Quality Assurance (QA), and Procurement to ensure project success.

•    Perform GMP operation per batch records if needed such as buffer preparation, cell counts, mammalian cell culture and transfection, virus manufacturing, and harvest per TFF, and filter integrity testing.

•    Assist on GMP campaign summary reports and review manufacturing documents (batch records, SOPs, and deviation reports, etc.).

•    Work with procurement, development, and QA to ensure timely material generation requirements and procurement to fill the need for GMP production, including drug substance and/or drug product final container components.

•    Work with facility team and QA team to ensure the readiness of equipment and GMP facility for GMP production.

•    Create user requirement specifications (URS) document for new equipment.

•    Cooperate with vendor, facility, and QA on new equipment IQ/OQ.

•    Demonstrate ability and understanding of Safe working habit and Material Safety Data Sheet (MSDS).

•    Work in cleanroom environment while adhering to Standard Operating Procedures (SOPs).

•    Document of all operations with strict adherence to cGMP documentation practices in Batch Records, Logbooks, Forms, etc. 

•    Monitor GMP Operations to ensure batch records and parameters control.

•    Analyze the process performance for control and data integration.

•    Other responsibilities as needed. Job Qualifications  

•    B.S. in Chemical or Biomolecular Engineering, Cell Biology, Bioengineering, Biotechnology, or related field with a minimum of 0-2 years of R&D experience.

•    M.S. in Chemical or Biomolecular Engineering, Cell Biology, Bioengineering, Biotechnology, or related field with a minimum of 0-1 years of R&D experience.

•    Previous experience working for a Contract Manufacturing Organization (CMO) preferred.

•    Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory.

•    Experience with cell culture or viral-based production including bioreactor operation.

•    Proven ability to work independently and to multi-task, manage multiple projects simultaneously.

•    Excellent teamwork, collaboration, interpersonal and communication skills (both verbal and written).

•    Organizational and planning skills .

•    Ability to work in a Team and collaborative environment.

•    Attention to detail and time management.

•    Basic computer skills in Microsoft (Word, Excel, Teams etc.).

•    Ability to work in a fast-paced environment.

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. 

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 by December 8, 2021.  Our main priority is the wellbeing, health, and safety of our people. We will be requiring 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 - 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.

Nearest Major Market: Washington DC

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