GMP, Manufacturing Associate II, Upstream
Company: Charles River Laboratories, Inc.
Posted on: May 15, 2022
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, well help you build a career
that you can feel passionate about.Job SummaryThe Upstream GMP
Manufacturing Associate II will work directly with a range of
bioreactor and recovery technologies such as single-use systems
(adherent and suspension), filtration technologies (TFF and depth),
and centrifugation following aseptic techniques and procedures in a
cGMP environment.Duties and Responsibilities Ensure safety of
manufacturing area and work practices.
Provide guidance, and direction to staff to create a
Coordinate planned upstream manufacturing floor activities.
Oversee and prepare upstream buffers/media aliquots in accordance
Assist Manufacturing Science & Technology in preparing Batch
Production Records (BPRs).
Ensure team members are qualified to execute GMP manufacturing.
Ensure proper documentation and execution of Batch Production
Records for assigned projects by actively participating in batch
Participate in and/or lead incident investigations.
Interact with other departments to implement approved process
Monitor processes using automated production systems and controls
with limited supervision.
Engage in equipment preparation, sanitation, and disinfection.
Perform other tasks as assigned to support GMP Manufacturing that
ensure sustainable right-first-time performance.
Other responsibilities as needed.Job Qualifications
High School Diploma or Associate Degree with 3-7 years of
experience in Biopharmaceutical Upstream Manufacturing in a GMP
Bachelor of Science in science or Engineering and 2-4 years of
experience in Biopharmaceutical Upstream Manufacturing in a GMP
Experience with Upstream Operations in the Biopharmaceuticals
Industry -single-use bioreactors, aseptic techniques, product
recovery (centrifugation, depth filtration, etc.).
Experience in the preparation of media and buffers at large scale
Preparation of material for autoclaving and operation of
Ability to operate manual and semi-automated in support of routine
production with minimal supervision.
Ability to work in a team and collaborative environment.
Great attention to detail. time management, and project
Previous work in viral or vaccine production highly desired.
Previous experience working for a Contract Manufacturing
Organization (CMO) preferred.
Good communication skills.
Basic computer skills-knowledge of Microsoft Word and Excel.Vaccine
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
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
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 clients 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 peoples 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.
Keywords: Charles River Laboratories, Inc., Rockville , GMP, Manufacturing Associate II, Upstream, Other , Rockville, Maryland
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