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Manufacturing Associate II

Company: TalentBurst, Inc.
Location: Cambridge
Posted on: November 26, 2022

Job Description:

Job Title: Manufacturing Associate II
Job Location: - Cambridge, Massachusetts (MA), (Onsite Site)

Job Duration: 6 months on contract basis initially -(with high possibility of extension/conversion from temp. to perm, depending on performance and business needs)

Job Requirements:

Is COVID vaccination required? : Yes, Fully Vaccinated
Shift timings: - Monday to Friday, 8 hour Shift.
1st shift from 7:30 am to 3:30 pm
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 new hire, Mon-Fri 1st shift for the first few weeks to allow for training before moving to Cambridge.

Basic Qualification:

  • 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

    Job Summary

    • The individual in this role will be part of a cohesive team responsible for producing custom small molecule materials to enable manufacturing of mRNA-based medicines for evaluation in human clinical trials.

    • He/she 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.

    • They 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.

      Job Responsibilities:

      • Execute manufacturing operations using disposable technologies, automation, and Manufacturing Execution Systems (MES) to produce small molecule constructs to support 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 of process data.

      • Monitor process operations to ensure compliance with specifications.

      • Assist in the investigation of procedural deviations.

      • Practice safe work habits and adhere to ***'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.


Keywords: TalentBurst, Inc., Cambridge , Manufacturing Associate II, Other , Cambridge, Massachusetts

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