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Manufacturing Associate - Onsite

Company: GTT, LLC
Location: Cambridge
Posted on: January 25, 2023

Job Description:

Manufacturing Associate - Onsite


  • Contract Duration 6+ months
  • Pay rate range $37 - $47.15/hr


    Job Description:


    • Our client is seeking a Manufacturing Associate for Specialty Small Molecule Manufacturing.
    • The individual in this role will be part of a cohesive team responsible for producing custom small-molecule materials to enable the manufacturing of mRNA-based medicines for evaluation in human clinical trials.
    • The -Manufacturing Associate will apply existing and new knowledge of process chemistry unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations.
    • The successful candidate will be able to document and communicate their technical and operational observations clearly and efficiently.
    • The -Manufacturing Associate will be able to operate pilot-scale equipment and interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Quality Assurance, Logistical, and Process Development Technology Transfer counterparts.


      Here's What You'll Do:


      • Execute manufacturing operations using disposable technologies, automation, and Manufacturing Execution Systems (MES) to produce small molecule constructs to support the production of mRNA products.
      • Demonstrate general knowledge of standard manufacturing practices and equipment.
      • Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions and process data.
      • Monitor process operations to ensure compliance with specifications.
      • Assist in the investigation of procedural deviations.
      • Practice safe work habits and adhere to our client's safety procedures and guidelines.
      • Utilize knowledge to improve operational efficiency.
      • Adhere to gowning procedures and maintain a clean general operating area.
      • Adhere to documented waste handling procedures to respect environmental regulations.


        Here's What You'll Bring to the Table:


        • Bachelor's Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field with 2-5 years experience or 7+ years of related GMP experience
        • Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
        • Ability to collaborate fluidly with peers, supervisors, and cross-functional support groups required
        • Exceptional written, oral communication, and organizational skills required


          Note:


          • This position is located at our research labs in Cambridge, MA.
          • The shifts are Monday-Friday 1st shift from 7:30 am to 3:30 pm and 2nd shift from 3:00 pm to 11:00 pm. (All new hires will report to Norwood or Burlington or Cambridge, location to be confirmed with a new hire, Mon-Fri 1st shift for the first few weeks to allow for training before moving to Cambridge.)


            About The Company:


            • Our client operates as a developer of messenger RNA therapeutics. The company develops and discovers drugs that produce proteins or antibodies inside patient cells. Its pipeline includes various drug modalities such as prophylactic vaccines, therapeutic vaccines, intratumoral immuno-oncology, localized therapeutics, and liver intracellular. Through its mRNA therapeutics platform, they develop and produce human proteins, antibodies, and Client proteins, which help in preventing, treating, and curing diseases. It also develops therapeutics in the areas of infectious disease, rare liver disease, immuno-oncology, and cardiovascular disease.
            • mRNA is now a turning point in the history of science, medicine, technology, and even humankind itself. With this breakthrough discovery, many of the world's biggest and most challenging medical problems are no longer a question of "how?" but merely a question of "when?"
            • Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

              #ZR2

Keywords: GTT, LLC, Cambridge , Manufacturing Associate - Onsite, Other , Cambridge, Massachusetts

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