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Manufacturing Associate I, 2nd Shift
Ref No.: 18-11446
Location: Cambridge, Massachusetts
Start Date: 09/07/2018
The Role: The client is seeking a Manufacturing Associate position based at their new GMP Manufacturing site in Norwood, MA. The individual in this role will be part of a cohesive team responsible for producing high quality mRNA-based medicines for evaluation in human clinical trials. He/she will apply existing and new knowledge of bioprocess 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 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. 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, such as pilot-scale chromatography systems. Assist in the investigation of procedural deviations. Practice safe work habits and adhere to the client's safety procedures and guidelines. Utilize knowledge to improve operational efficiency. 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: Bachelor's degree and 0-2 years of experience in a GMP manufacturing environment.

Why join? We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured – at a breadth, scale and speed not common in the biopharma industry.