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.
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. This position represents the Gene Therapy CMC team on the Global Product Team (GPT)
- Develop CMC Product Strategy: Plan and execute CMC product strategy including process and assay development, characterization, validation, technical transfer, CMC filing documents, and support stability and shelf life for products
- Drive communication and alignment between Gene Therapy CMC team and GPT: Communicate GPT’s product strategy and interests to Gene Therapy CMC team, seek inputs from functions, and ensure functional team perspectives (interests and constrains) are fully considered in the overall product strategy and execution plan
- Accountable for CMC submission (IND, IMPD, BLA) and represents CMC by agencies as a SME
- Develop budget, resources requirements & schedule to deliver CMC strategy and plans
- Provide CMC Stage Gate deliverables
- Ensure appropriate approval/endorsement of team recommendations and work streams
- Drive consensus and timely decision making
- Open communication and collaboration with internal and extermal partners
- Your office is located in Orth/Donau - 25 km from Vienna
What you bring:
- Degree (MSc or PhD) in Biochemistry, Protein Chemistry, Chemical Engineering or related disciplines with relevant experience in the biotechnology/pharmaceutical industry
- Profound knowledge of all Gene Therpay relevant guidelines stated by main authorities (FDA, EMA, PMDA, ICH)
- Strong background in project management and leading cross functional teams
- Deep experience in working in global teams
- Ability to develop and manage high performing project teams
- Demonstrate teamwork/collaboration and the ability to communicate appropriately and effectively
- High level of customer orientation and organizational skills
- Resolve and escalate project issues as appropriate
- Enthusiastic, decisive and motivating personality
- Excellent verbal and written communication skills in English and German
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 € 4.369,11 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 and Bonus is possible.
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