Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a External Development Lead (AD-PDT) in our Vienna office.
Here, you will be a vital contributor to our inspiring, bold mission.
The Plasma-Derived Therapies (PDT) BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients’ and health care provider’s expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases.
PDT Pharmaceutical Science & Devices is an agile and innovative team that develops novel and improved plasma derived drug products including intelligent medical devices & technologies. The expanding Analytical Development Department (AD-PDT) is responsible for establishing new innovative methods for product characterization, supporting process development, and for the release of non-clinical as well as clinical material. The methods are developed either internally at the Vienna site or externally with qualified Contract Research Organizations (CROs).
The External Development Lead is responsible for ensuring preclinical and clinical material release testing as well as for product characterization by qualified CROs. This includes technical oversight of external method establishment and independently managing all CRO activities including coordination with internal functions such as Project Teams, Procurement, Legal, and Subject Matter Experts.
- Act as central contact between internal and external teams for outsourced methods
- Scientific evaluation and selection of best-suited methods for projects with support of Subject Matter Experts
- Drive the CRO evaluation and selection process
- Create project proposals including a description of the project and a desired budget and timeline for completion
- Technical review of proposals submitted by CROs
- Deliver quality contracts through close collaboration with partner functions to minimize regulatory, legal, and financial risks
- Track status of the agreement and report on progress into project teams
- Ensure vendors are delivering to contract milestones and quality standards
- Collaborate with all involved teams to ensure that project goals, objectives, and deliverables are achieved
- Manage relationship with strategic suppliers and evaluate performance of CRO
Your Skills and Qualifications:
- Advanced degree (PhD or MD or equivalent
- A minimum of 3 years’ work experience with outsourced projects, budgeting, and collaboration with external partners
- Strong knowledge of project management tools and methodologies
- In-depth understanding of project life cycle
- Draft initial contracts and amendments using templates
- Good communication, organization, and time management skills
- Technical understanding of required technologies
- Knowledgeable of GMP/cGMP; ICH Guidelines; Release of drug products for preclinical and clinical studies
- Professional and adaptable / agile;
- Requires minimal supervision
- Independently author contractual documents and design and revise templates as required
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 € 4751,92 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.
AUT - Wien - Industriestrasse 72