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.

PD Process Validation Senior Scientist

Department: Process Development
Location:

Purpose of the Position:

Reporting to the Technical Manager, Process Validation, this role will provide leadership and support of process validation activities for Avecia’s manufacturing processes

 

Key Job Responsibilities:

  • Preparation of documentation (protocols and reports) to enable Avecia’s process validation programs to be executed efficiently.

  • Provide leadership and direction in support of validation activities specific to manufacturing processes, internally and with clients.

  • Act as the Validation lead on cross functional projects to ensure pre-commercial and commercial projects are completed in line with procedures, regulations and business needs.

  • Ensure consistency and standardization of approaches to process validation across projects and sites.

  • Collaborate with development teams in process characterization efforts that precede PPQ qualification.

  • Mentor and train junior scientists in requirements for preparation of process validation documents and systems

  • Review of relevant internal procedures and guidance related to process validation

  • Draft/review product specific validation master plans and validation summary reports

  • Draft/review product specific continued process verification protocols and reports

 

Job Knowledge Required:

  • Bachelors Degree in science-related and 10+ years related experience or Masters/Ph.D. Degree and 3-5 years of related experience
  • Knowledge of ICH guidances, and US and European process validation requirements
  • Minimum of two (2) years of applied validation experience.
  • Experience of process development, scale up and manufacturing of APIs/intermediates
  • Excellent written and verbal communications, including technical writing. Microsoft Office Software.
  • Proficiency in preparation of technical presentations, reports and publications in the English language
  • Knowledge of statistics and their application to such aspects as process sampling and data trends analysis is not required but is beneficial

Equal Opportunity Employer

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