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Senior Manufacturing Associate (Contract)

  • Date Posted November 20, 2020
  • Location Framingham, Massachusetts
  • Job Type Contract
  • Job ID 16714

Our client, a pharmaceutical leader focused on the development and commercialization of treatments for rare diseases, oncology, immunology and more is currently seeking a Senior Manufacturing Associate to join their Cell Culture Operations Department. This is a 1-year long contract position with the possibility of extension. The Senior Manufacturing Associate will work onsite bi-weekly, rotating 12 hours per day schedule with every other weekend off. The hours are 7:15am to 7:15pm

Responsibilities

  • Small Scale Team: Demonstrates general knowledge of mammalian tissue culture processes and aseptic techniques.
    • Provides daily monitoring of seed cultures including sampling and in process assays (cell counting).
    • Cleans and builds equipment for manufacturing use including spinner flasks.
  • Large Scale Team: Demonstrates general knowledge of mammalian tissue culture processes and aseptic techniques
    • completes tasks in support of large-scale cell culture bioreactor operations.
    • Provides daily monitoring of cultures and bioreactor processes including sampling and in process assays (cell counting).
    • Performs PM, CIP, and SIP operations to prepare equipment for manufacturing operations
  • Builds, cleans and sterilizes equipment to support Media/Buffer Preparation, Purification and Cell Culture equipment preparation.
  • Prepares equipment and materials for production, including the beginning, middle, or end stage of the ‘manufacturing’ process of a product.
  • 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.
  • Performs batch record review, procedure revisions and work order generation.
  • Interacts with other support functions such as Quality Assurance, Quality Control, Manufacturing, Engineering, MSAT, Validation, etc.
  • Mentors less experienced operators and performs support function for supervisor.
  • May be asked to represent the organization at meetings such as scheduling meetings, +QDCI, deviation review and project meetings.

Qualifications

  • 3-5 yrs plus experience in manufacturing and cell culture
  • Effectively demonstrates understanding of GMPs and how they apply to specific responsibilities
  • Utilizes manufacturing knowledge to improve process operations and affect positive change.
  • Ability to troubleshoot basic mechanical operations.
  • Ability to follow detailed instruction set in order to execute production activities
  • General understanding of gas and liquid filtration.
  • Understanding of PM, CIP, and SIP operations to prepare equipment for Media Preparation operations.
  • Understanding of application of sanitization practices.
  • Ability to measure raw materials and operate basic benchtop instruments.

If you are interested in this position, please send you resume to apowell@daleyaa.com

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