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GMP Manufacturing Associate III, Downstream

Company: Charles River Laboratories
Location: Rockville
Posted on: January 15, 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 GMP Manufacturing Associate III, Downstream will work directly in activities associated with purification that apply a broad knowledge of biological, bioprocess, and mechanical principles to execute complex operations that result in clinical and commercial stage medicines to dramatically improve the human condition through gene therapy. The activities will take place in a cleanroom following aseptic techniques and procedures in a cGMP environment.
Duties and Responsibilities

  • Perform Downstream purification activities such as Chromatography, Tangential flow filtration (TFF), Ultracentrifugation, and Final Formulation steps.
    • Work in cleanroom environment while adhering to Standard Operating Procedures (SOPs).
      • Prepare, sanitize, and disinfect equipment to prevent microbial contamination.
        • Monitor processes using automated production systems and controls with supervision.
          • Demonstrate ability to troubleshoot basic mechanical operations.
            • Obtain and perform in-process sampling.
              • Follow verbal and written procedures in operating production equipment and performing processing steps, accurately complete appropriate production documentation.
                • Prepare buffers and solutions needed for Downstream activities.
                  • Prepare buffers at large scale ( 20L).
                    • Effectively communicate and interface with team to ensure the completion of daily activities.
                      • Perform various filter integrity tests throughout the process.
                        • Document all activities in Batch Records, Logbooks, Forms, etc.
                          • Exercise intellectual curiosity by identifying and escalating events and subtle variances that deviate from normal operation..
                            • Provide training to junior team members.
                              • Create, edit, and review Production Batch Records and Standard Operating Procedures.
                                • Operate manual and semi-automated equipment in support of routine production with minimal supervision.
                                  • Participate in incident investigations.
                                    • Interact with other departments to implement approved process improvements.
                                      • Perform other tasks as assigned to support GMP Manufacturing that ensures sustainable right-first-time performance.
                                        Job Qualifications
                                        • Bachelor of Science in science or Engineering and 5-7 years of experience in Downstream biologic production processes in a GMP environment in a Life Sciences Company; or
                                          • High School Diploma or Associate Degree with 6-10 years of experience in Downstream biologic production processes in a GMP environment in a Life Sciences Company.
                                            • Technical understanding of purification processes from cell culture processes.
                                              • Hands-on experience with chromatography systems (AKTA systems at different scales) and approaches (Affinity, IEX, MMC), TFF modalities, and single use mixing systems.
                                                • Organizational and planning skills.
                                                  • Ability to work in a Team and collaborative environment.
                                                    • Attention to detail and time management.
                                                      • Previous work in viral or vaccine production highly desired.
                                                        • Previous experience working for a Contract Manufacturing Organization (CMO) preferred.
                                                          • Communication skills (writing, speaking, comprehending).
                                                            • Basic computer skills including 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 ( 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 , GMP Manufacturing Associate III, Downstream, Other , Rockville, Maryland

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