Senior QC Scientist and Technical Lead (f/m)


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Primary role

  • QC oversight and effective management of Shire Contract test laboratories utilized from release and ongoing stability testing
  • Development of strategic short term and long term approaches to release and stability method performance and improvements, analytical support for process improvements, product comparability assessments
  • Interpretation of data trends for both release and stability, life cycle of methods and other technical support as required
  • Expertise and technical leadership managing deviations, investigations, OOS, CAPAs, change requests and improvement initiatives
  • Lead investigator with strong understanding of compliance and cGMP?s, strong scientific judgment and leadership in decision making
  • Participate in cross functional teams to close investigations, determination of root cause and implementation of appropriate CAPAs
  • Create and presents trending and metrics reports on deviations and corrective actions
  • Lead management of the document change requests for method SOPs
  • Provide representation to tech transfer and CMC teams as needed, review of process and method validation initiatives in support of the QC laboratories in the resolution of OOS investigations
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
  • Support of validation activities for QC including authoring and/or reviewing protocols, coordinating testing with the functional area managers
  • Supporting regulatory activities including, but not limited to regulatory inspections and filings related to general analytical methodologies

Requirements

  • Experience of Technology Transfer of analytical methods
  • Ph.D. in Chemistry, Biology or other related fields with >5 years of relevant Postdoctoral/Industrial experience or M.S. with >7 years of relevant experience
  • Experience dealing with contract testing organizations is preferred
  • Team leadership
  • Good knowledge of statistical techniques in the use of problem solving data analysis
  • Ability to demonstrate standards of leadership - managing complexity/ innovations
  • Customer Focus Flexible Team Player Good influential skills
  • Regulatory filings and inspections
  • Strong knowledge of EU cGMPs and FDA guidelines
  • Experience with lean processes
  • Ability to work during routine business hours but be flexible to cover US and JP business hours on occasion
  • Ability to travel approx. 20%
  • Fluency in German and English

As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees - our biggest asset - who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.

We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success.

The minimum salary for this position is € 4.225,44 gross per month (full-time); increased payment is possible. We are looking forward to your application.

Austria

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