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Manufacturing Project Coordinator (253)

Employer
Nitto Avecia Pharma Services
Location
Milford, Massachusetts, United States
Start date
Jul 8, 2019

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Discipline
Clinical, Clinical Project Management, Manufacturing & Production
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown
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Job Details

Equal Opportunity Employer

Purpose of Position:
  • To serve as a liaison between the manufacturing team and the project management team to assure all manufacturing related activities and expectations are communicated to the direct manufacturing team.
  • Act as the manufacturing representative on cross functional projects teams and communicate the relevant information required to successfully execute a manufacturing campaign


Key Responsibilities:

Originate, revise, approve, and/or review GMP documentation including but not limited to:

-Process Instructions,SOP's, Change Controls and Planned Deviations
  • Complete tasks in Oracle system (including generation of product item numbers / entering raw materials required for a campaign etc)
  • Review project specific documents including but not limited to:

-Manufacturing Process Outline (MPO), Manufacturing Process Formula (MPF), Project Change Controls, Work Orders, Project Representation
  • Represent Manufacturing on Project Teams, communicating and delivering project expectations.
  • Attend daily/ weekly internal and external customer meetings to report manufacturing updates.
  • Keep detailed records of project campaigns
  • Assist in technical and safety risk assessment and the communicate any risks to the manufacturing team.
  • Assist in project specific compliance investigations.
  • Interact with various functional groups and the customer to accomplish project goal
  • Work with the project managers and customers to resolve Manufacturing specific questions and Process Instruction comments


Job Knowledge Required:
  • This is specialist position requiring a comprehensive knowledge of the cGMP requirements for pharmaceutical manufacturing or API manufacturing
  • Minimum education requirements include a science related Bachelor's degree or equivalent work experience.
  • Knowledge of biotechnology / chemical manufacturing processes and equipment is preferred

Company

With over 25 years of experience in oligonucleotide development and production, and over 1000 sequences manufactured, Avecia has played an integral role in the advancing oligo therapeutic market. Our mission is to continue to build value for our customers, as they progress through drug development into commercialization. And as a member of the Nitto Denko Corporation (www.nitto.com), Avecia is committed to the future of the oligonucleotide market. We are driven by innovative ideas and flexible solutions, designed to provide our customers with the best in service, quality, and technology.

Additional locations:

33 Locke Drive
Marlborough, MA 01752
 
8560 Reading Road
Cincinnati, OH 45215
Tel: (513) 679-3000

Company info
Website
Mini-site
Nitto Avecia Pharma Services
Phone
+1-949-951-4425
Location
10 Vanderbilt
 Irvine
CA
92618-2010
US
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