The ideal candidate will bring significant Formulation Development experience in the field of protein-based biopharmaceuticals coupled with the capability for innovative thinking across the CMC space to develop transformational medicines. Similar competences within the area of gene therapy would be a benefit.
If you share our genuine desire and passion to make a significant contribution to understanding and leading the drug product development solutions within Biopharmaceuticals and Gene Therapy, we are looking forward to meeting you!
- Planning, execution, documentation and reporting of formulation development studies such a pH solubility screens, stress studies (Temperature, Light exposure, Shaking, Oxidation), temperature hold time and stability studies
- Planning, execution and documentation of process development and optimization studies such as those involving the fill/finish activities of Pre-clinical and Clinical drug product manufacture
- Supporting Tech-Transfer and scale -up activities for drug product manufacture
- Authoring and reviewing the CMC sections of regulatory documents
- Serving as the formulation development expert on matrix cross-functional project teams
- Working in an international team with a number of teams, local and international
Your Skills and Qualifications:
- Significant experience in Formulation and Process Development in gene therapy and/or protein based biopharmaceuticals/vaccines
- M.Sc. degree in biology, chemistry or related science
- Good knowledge and experience with applying Quality by design principles and statistical analysis tools for evaluation of drug substance and drug product stability
- Excellent oral and written communication skills in English, including the ability to deliver good presentations and well written technical documents
- Dynamic and passionate about science
- Must be well-organised and self-motivated
- Ability to lead effectively and concurrently on multiple projects in a goal-oriented, timeline driven, and dynamic work environment while ensuring quality and accuracy
- Good scientific knowledge and a track record in biopharmaceutical drug development and manufacturing, gained from working within the Pharma or Biotech industry
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 € 3.270,89 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. We are looking forward to your application!
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