Senior Manager, Downstream MSAT 1
Company: Charles River Laboratories
Posted on: January 16, 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, 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
The Senior Manager/scientist will lead on Downstream process scale
up from internal or external process development to GMP
manufacturing process on chromatography, filtration technologies
(TFF and depth), and ultracentrifugation. Developing material
specification, process/equipment risk analysis and GMP
documentation are required for Engineering and GMP runs.
Essential Duties & Responsibilities:
--- Lead and conduct process scale-up/engineering runs at pilot
scale or GMP facility prior to GMP manufacture, expertise on
downstream AKTA ready/pilot, TFF system, ultracentrifugation and
various depth filtration operation.
- Design large scale operation and develop GMP documentation for
Engineering run and GMP operation such as buffer usage, virus
separation per AEX/affinity column, various depth filtration
understanding and different skid system, and harvest per TFF (share
- Author and review manufacturing documents (batch records, SOPs,
and deviation reports, etc.) and summary reports working with
quality systems (QC and QA) on product release.
- Work with Procurement, Development, and Quality Assurance to
ensure timely material generation requirements and procurement to
fill the need for GMP production.
- Lead process validation, PPQ and commercial campaign
preparation if needed.
- Lead in process control on impurity removal, and critical
quality attribute (CQA) control.
- Other responsibilities as required.Job Qualifications Education
- MS or PhD in Virology, Biochemistry, Biophysics, Molecular
Biology, or related field with > 5 years of experience in
Process development, or GMP operation .
Qualifications/Skills & Abilities
--- Working experience with virus production is preferred.
- Experience with AKTA ready/pilot, ultracentrifugation and
- Excellent verbal and written communication skills.
- Microsoft Office experience (Word, Excel, PowerPoint,
- Good critical thinking skills and strong communication
- Ability to problem solve.
- Ability to resolve client or GMP operation issues for continues
- Well-organized, able to manage multiple projects at a
- A Strong team player with the ability to adapt, be flexible,
and work independently.
Physical Requirements/Work Environment/Travel Requirements:
--- Must be able to lift up to 40 lbs.
- Standing, sitting, pushing, pulling, walking.
- Some weekend work or night shift work maybe needed according
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.
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.
Keywords: Charles River Laboratories, Rockville , Senior Manager, Downstream MSAT 1, Executive , Rockville, Maryland
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