CMC Lead for Gene Therapy (m/f)


  • Company:
    Shire
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    7 days ago
  • Category:
    General

Takeda is the leading biotech company in rare diseases and sees a significant need for rare disease innovation. One example is Takeda’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 Takeda 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!

**_Notice to Employment / Recruitment Agents:_**

_Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration._

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.