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Manufacturing Associate
Ref No.: 18-12044
Location: Norwood, Massachusetts
Start Date: 09/18/2018
The Role:
Seeking a Manufacturing Associate position based at to our new GMP Manufacturing site in Norwood, MA.

The individual in this role will be part of a cohesive team responsible for enabling production of high quality mRNA-based medicines for evaluation in human clinical trials. The candidate will apply existing and new knowledge of laboratory unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. As part of the Manufacturing Support Team, the individual is responsible for buffer and material preparation, weigh and dispense, and equipment preparation operations (autoclave and glass wash).

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 bioprocessing equipment and interact fluidly with peers and supervisors in the Pilot Plant, and cross-functionally with Quality Control, Quality Assurance, Logistical, and Process Development technology transfer counterparts.

Here's What You'll Do:
  • Be a consistent contributor, under the guidance of a shift leader.
  • Apply technical knowledge to support team operations and collaborate with peers.
  • Execute to a high standard with while following pre-established guidelines.
  • Ensure workstation is operating efficiently and correctly including coordination with other operators.
  • Demonstrate general knowledge of standard laboratory 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.
  • Complete tasks in support of large scale manufacturing, including in the care of high-value capital equipment
  • Assist in the investigation of procedural deviations.
  • Practice safe work habits and adhere to safety procedures and guidelines.
  • Utilize knowledge to improve operational efficiency and drive toward operational excellence.
  • Adhere to Pilot Plant 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
  • BS/BA and 1-2 years industry experience, preferably within GMP or GLP
  • Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company
  • Drive for continuous improvement both individually and as part of a team
  • Ability to collaborate fluidly with peers, supervisors and cross functional support groups required
Exceptional written, oral communication, and organizational skills required