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Senior Manager, Downstream MSAT 1

Company: Charles River Laboratories
Location: Rockville
Posted on: January 16, 2022

Job Description:

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 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 force control).
  • 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 & Experience

    • 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 filtration operation.
      • Excellent verbal and written communication skills.
      • Microsoft Office experience (Word, Excel, PowerPoint, etc.).
      • Good critical thinking skills and strong communication skills.
      • Ability to problem solve.
      • Ability to resolve client or GMP operation issues for continues process improvement.
      • Well-organized, able to manage multiple projects at a time.
      • 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 project requirements.
          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.

Keywords: Charles River Laboratories, Rockville , Senior Manager, Downstream MSAT 1, Executive , Rockville, Maryland

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