Job Opportunities with Nitto Denko Avecia in the USA
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Why work at Avecia?

As a leading drug development services company for oligonucleotide therapeutics, the first step in our DNA/RNA sequence is to work with a great team of people.

At Avecia, our team approach allows you to excel in your individual area of expertise as well as to be part of a group of professionals that has the support of management and peers from various backgrounds. And while we’re focused on results, we still maintain our flexibility and enjoy camaraderie and the benefits of work/life balance. Make the next move in your progression of success and join Avecia.

At Avecia, we encourage and value people from diverse ethnic and cultural backgrounds to contribute to our collective success. It is Avecia’s policy to conduct business without regard to an individual’s disability or any other protected status. We are fully committed to the concept and practice of equal opportunity and affirmative action in all aspects of employment and encourage all to apply.

Manufacturing Project Coordinator

Department: Manufacturing
Location:

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
  • -Standard Operating Procedures
  • -Change Controls
  • -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

  • Train manufacturing staff on project specific details

  • Communicate project details and status to Manufacturing Management Staff.

  • Responsible for performing all work within company and cGMP regulatory compliance.

  • Responsible for staying current with the prescribed training curriculum specified for the job title.

  • Responsible for the implementation of assigned procedures working within defined schedules.

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 goals

- 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 Bachelorís degree or equivalent work experience.

  • Knowledge of biotechnology / chemical manufacturing processes and equipment is preferred

  • Knowledge of oligonucleotide chemistry is preferred

Equal Opportunity Employer

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