Plasma-derived therapies are critical, life-saving medicines which patients with rare and complex diseases around the world rely on every day. Global demand for these therapies, particularly immunoglobulins, has increased dramatically over the last 15 years, and continues to grow. Takeda is established as second largest player globally in producing plasma-derived therapies (PDT). Leveraging on 75+ year pioneering legacy, Takeda believes there is tremendous potential to do more to meet patients’ and health care providers expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, autoimmune and other complex diseases.
Within PDT R&D, Translational Research & Non-clinical Development Team (TR&NCD) is dedicated to bringing forward new plasma-derived therapies for patients with rare and complex diseases. It plays a pivotal role in supporting programs from early development to market authorization by being responsible for discovery, non-clinical development, translational & biomarker research and bioanalytical support of clinical programs.
For this role we are seeking a versatile and experienced candidate to primarily extend bioanalytical capabilities of the Team with emphasis on hematology/coagulation assays. The Manager Bioanalytical & Biomarker, PDT Translational Research will be responsible for driving innovative ideas to support various early- and late-stage assets. The incumbent will closely work with other members of TR&NCD team to develop biomarker strategy for patient stratification and responder analysis, as well as with various key stakeholder functions to represent translational research function in cross-functional program development teams. Since the organization is young and growing, the incoming candidate will have the opportunity to streamline the future vision and operating model of the TR&NCD team and rapidly grow beyond initial responsibilities. The role’s primary location is Vienna, Austria, with about 10% travel time.
- Responsible for conceptualizing, designing, and managing bioanalytical and biomarker assays, assay validation, sample testing, as well as data interpretation and reporting.
- Manages or leads projects across the PDT portfolio and schedules activities in accordance with line function and program/corporate goals/assignments and priorities supporting Discovery, Nonclinical and Clinical programs.
- Designs Biomarker Plans and Immunogenicity Risk Assessments.
- Effectively manages both internal and external work, including interactions with technical and administrative staff at CROs or external vendors to deliver high quality results in a fast-paced environment.
- Implements innovative approaches and proposes new biomarker strategies and bioanalytical plans. Develops new methods and extends technology to drive applied science into new application areas.
- Provides bioanalytical SME input to cross-functional program teams. Acts as a resource and provides guidance to colleagues.
- Authors or contributes to Clinical Study Report sections, regulatory documents and abstracts/manuscripts for publications.
- Reviews assay validation and bioanalytical reports and provides training and mentorship to internal staff.
Your Skills and Qualifications:
- Academic degree MSc or above
- 5+ years of industry/CRO experience in area of biomarker and bioanalytical development.
- Familiarity and experience with global regulatory guidelines, expectations and corresponding industry best practices is required, e.g., FDA Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP).
- Experience in placing and managing external work at CROs/CMOs is required.
- Recognized as having advanced expertise in their field of training and broad knowledge of drug discovery and development. Applies independent judgment and direction to design, execute and interpret experiments in compliance with appropriate global regulatory guidance.
- Experience in large molecule assessments for PK, toxicology and biodistribution studies as well as ADA and biomarker studies in various matrices and tissues (brain, spinal cord, liver, kidney, spleen, lymph nodes) to support both non-clinical and clinical studies of advantage.
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. For more insights into Takeda click here.
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.
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