Gene Therapy CMC Development Lead (f/m/x)


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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join the Gene Therapy Process Development team as a Gene Therapy CMC Development Lead in Orth, Austria (near Vienna).

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. In this role, you will contribute to Takeda’s mission by focusing on leadership and management of complex technical programs

Here, you will be a vital contributor to our inspiring, bold mission.

As a Gene Therapy CMC Development Lead you will:

  • Work on gene therapy development programs, responsible for all aspects of Chemistry, Manufacturing, and Controls (CMC). You will lead cross functional pharmaceutical science teams and collaborate with other key functions to enhance the Takeda R&D portfolio.
  • Manage business critical technology collaborations, serving as a single point of contact.
  • Manage business critical technology & capability expansions
  • Actively support the broader Gene Therapy and Pharmaceutical Sciences organization

You will be accountable for:

  • Development and execution of Pharmaceutical Sciences CMC product strategy
  • Planning and managing of related budget and resource requirements
  • Planning and execution of related development work packages, like process and analytical development, manufacturing site selection, technology transfer, non-clinical and clinical manufacturing, IND/IMPD authoring etc.
  • Ensuring appropriate approval/endorsement of team recommendations
  • Driving consensus and timely decision making
  • Open communication and collaboration with internal and external partners
  • Translation of global development program strategy into executable work packages
  • Representation of the broader organization and project teams in various committees
  • Program/timeline/budget risk identification and management

The position requires education, behavioral competencies, and skills as follows:

  • MSc or higher with a minimum of 8 years’ experience in process or analytical development of gene therapy or biologics in the pharmaceutical industry
  • Extensive experience in project management
  • Demonstrated ability to lead cross functional teams
  • Proven record of technical leadership
  • Excellent communication and presentation skills in English and German
  • Willingness to learn and grow on a personal, leadership and technical level
  • High resilience and ability to independently manage job priorities
  • Strong organizational skills
  • Negotiation and strong persuasive abilities
  • high degree of self-awareness, self-motivation, initiative, and attention to detail

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer.

We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.

Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 4.527,78 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.

Locations

AUT - Orth an der Donau

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


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