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2018-11-15 Manages project teams and is responsible for providing technical leadership to cross-functional teams; Leads & contributes as a key member of various
Titel

CMC Lead for Gene Therapy (m/f)

Dienstort Orth an der Donau Niederösterreich Unternehmen Shire
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Beschäftigungsart Vollzeit Position Teamleitung Gehaltsangabe 4.225,44 € /brutto Jetzt online bewerben

CMC Lead for Gene Therapy (m/f)

Shire am 08.12.2018 in Orth an der Donau




CMC Lead for Gene Therapy (m/f)

Job-ID: R0029454
Location: Austria - Orth an der Donau (Baxalta)
Category: CMC Operations

Shire is the leading biotech company in rare diseases and sees a significant need for rare disease innovation. One example is Shire’s gene therapy hub in Orth an der Donau. In the past years the company has established a solid gene therapy platform based on adeno-associated viruses, which comprises vector optimization, analytical assays, scale-up expertise and a GMP-compliant production process. The experience gained in the process is also offered to external partners. The CMC Lead is a key role within our Gene Therapy business as it sets product development strategy to enable execution of Chemistry, Manufacturing, and Controls (CMC) activities throughout a product's lifecycle.

About the position:

  • Manages project teams and is responsible for providing technical leadership to cross-functional teams
  • Leads & contributes as a key member of various cross-functional teams focused on product development support.
  • Is central interface to other departments (Process and formulation development, Process Analytics, Analytical development, manufacturing, research, QA, QC, engineering, supply chain, validation, tech transfer, regulatory functions, external partner and authorities)
  • Translates product strategy and plans into the unit's and team’s goals
  • Develops budget, resources requirements & schedule to delivery
  • Ensures appropriate approval/endorsement of team recommendations and work streams

Skills you need:

  • University degree in Biochemistry, Protein Chemistry, Chemical Engineering or related disciplines with relevant experience in a biotechnology/pharmaceutical environment
  • Direct drug development experience
  • Experience with application of risk-based approaches in decision making
  • Experience in process development and characterization leading to definition of design space
  • Experience in development and implementation of process control strategy using QbD principles
  • Teamwork/collaborative abilities and excellent communication skills at all levels of hierarchy
  • High level of customer orientation and organizational skills

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!

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