Manufacturing Associate III

Published
November 21, 2020
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Description

Job Title: Manufacturing Associate III
Location: Framingham, MA
Duration: 18 MONTHS  

The Cell Culture Operations Department performs small and large scale cell culture
operations, media preparation, equipment preparation, clean in place (CIP) and steam in
place (SIP), and Preventative Maintenance of process equipment as part of a 24/7 large-scale
biologics manufacturing facility.
This position is responsible for performing a variety of complex tasks under general guidance
and in accordance with the manufacturing instruction set and current GMPs
 
Core Responsibilities:

  • Practices and promotes safe work habits and adheres to Sanofi's safety procedures and guidelines.
  • Effectively demonstrates understanding of GMPs and how they apply to specific responsibilities.
  • Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
  • Identifies, escalates and documents events and subtle variances that deviate from normal operation; participate as needed in investigations.
  • Maintains cleanliness and orderliness of process area.
  • Ensures production area is stocked with supplies.
  • Performs batch record review, procedure revisions and work order generation.
  • Fulfills role of lead trainer on numerous operations and is an area SME.
  • Interacts with other support functions such as Quality Assurance, Quality Control, Manufacturing, Engineering, MSAT, Validation, etc.
  • Utilizes manufacturing knowledge to improve process operations and affect positive change.
  • Demonstrates ability to troubleshoot basic mechanical operations.
  • Effectively utilizes Microsoft office applications.
  • Mentors less experienced operators and performs support function for supervisor.
  • Fulfills the role of Team Lead in the absence of the team supervisor. Responsible for assignment of duties to all team members, ensuring execution of duties, communication at daily scheduling meetings, and providing technical support as needed.
  • May be ask to represent the organization at meetings such as scheduling meetings, +QDCI, deviation review and project meetings.

 
Additional Responsibilities:
 
• Small Scale Team
o Demonstrates general knowledge of mammalian tissue culture processes.
o Demonstrates general knowledge and practice of aseptic techniques.
o Provides daily monitoring of seed cultures including sampling and in process assays (cell counting).
o Cleans and builds equipment for manufacturing use including spinner flasks.
• Large Scale Team
o Demonstrates general knowledge of mammalian tissue culture processes.
o Completes tasks in support of large scale cell culture bioreactor operations.
o Provides daily monitoring of cultures and bioreactor processes including sampling and in process assays (cell counting).
o Demonstrates general knowledge of aseptic techniques.
o Performs PM, CIP, and SIP operations to prepare equipment for manufacturing operations.
• Equipment Preparation
o Demonstrates ability to follow detailed instruction set in order to execute production activities.
o Builds, cleans and sterilizes equipment to support Media/Buffer Preparation, Purification and Cell Culture equipment preparation.
o Demonstrates knowledge of Autoclave.
o Demonstrates knowledge of Clean out of Place (COP).
• Media Preparation
o Demonstrates general understanding of gas and liquid filtration.
o Demonstrates understanding PM, CIP, and SIP operations to prepare equipment for Media Preparation operations.
o Demonstrates understanding of application of sanitization practices.
o Practices ability to measure raw materials and operate basic benchtop instruments.
o Directs daily work activities and training of other staff.

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