Analytical Development Representative (AD-PDT) (f/m/x)
Analytical Development Representative (AD-PDT) (f/m/x)Job ID R0080575 Date posted Nov. 04, 2022 Location Vienna, Austria
The 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 responsibilities for the Analytical Development Representative (AD-Rep) are:
- Project Manager for analytical product topics, method development, testing strategies, and budget
- Owns specification and Justification of Specification (JoS)
- As TMC member serves as coordinator or facilitator of PSSC meetings for justification report; presentation of strategy in the PSSC meetings
- Signs responsibility for ensuring preclinical GLP material release testing
- Oversight of method development and qualification/validation in the required qualification status
- CTO/CMO Management for GLP release and stability testing for DS and DP for non-clinical programs
- Single responsibility for Reference Standard performance monitoring, stability, and requalification for non-clinical programs
- Author of relevant sections for regulatory submissions (JoS, specifications, elucidation of structure, impurities, comparability etc.)
- Oversee deviations and OOS/OOT, and investigations at CTO/CMO related to method issues
- Reviewers for method validation and method transfers
- Pharm Sci team member
Your Skills and Qualifications:
Advanced degree (PhD or MD or equivalent) and 5+ years work experience in Analytical Development
A minimum of 5 years work experience with outsourced projects, budgeting, and collaboration with external partners
- Strong scientific background in analytical method development
- Knowledge of project management tools and methodologies
- Good organization, communication, and time management skills
- Technical understanding of required technologies
- Ability to work at mid-level proficiency in a highly cross-functional and global team environment
- Communicates progress or the status clearly and concisely within team and colleagues; documents issues and/or concerns concisely; timely and effectively reports issues to supervisor or senior staff member(s).
- Ability to both generate and share knowledge within team and cross-functionally.
- Exercises mid-level time management and prioritization skills and can successfully manage multiple tasks simultaneously.
- Deep knowledge of analytical test method development, GLP and compliance requirements, release of drug products for preclinical studies, and CMC requirements for IND filings; mid-level knowledge of stability studies, stability trending/statistics.
- Team player with a flexible personality but able to be persistent and assertive.
- Highly reliable, self-motivated, and have a curious personality open to learning and development.
- May have expertise outside of traditional program and/or initiative responsibilities (e.g., expert in statistical analysis or stability, business system expertise/leadership/ownership or other relevant and appropriate responsibilities at an entry level.
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 € 4 751,92 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
LocationsAUT - Wien - Industriestrasse 72
Time TypeFull time
Business Area Overview
As a trusted global leader and industry partner who is reimagining plasma and exploring its untapped potential, Takeda’s Plasma-Derived Therapies (PDT) Business Unit is dedicated to transforming the lives of patients worldwide who rely on these lifesaving and life-sustaining therapies.
With an 80-year legacy of developing treatments for rare and complex chronic diseases, we thrive on innovation, offering a broad, differentiated portfolio of more than 20 plasma medicines with integrated care solutions to patients in more than 80 countries.
Powered by ~ 17,000 Takeda employees, our ~200 high-quality BioLife donation centers, a dedicated R&D team, and eight world-class plasma manufacturing facilities, we are unleashing data, digital and technology to transform our end-to-end operations and set new industry standards.
This enables us to innovatively and sustainably meet the growing and changing needs of patients, our people, and our planet, today and in the future.
What makes a successful team member within PDT at Takeda?
- Bold Thinker
Global Plasma Leaders Collaborate to Accelerate Development of Potential COVID-19 Hyperimmune Therapy
Partnership brings together world-leading plasma companies to focus on developing and delivering a hyperimmune immunoglobulin in the global fight against COVID-19.Explore more Global Plasma Leaders Collaborate to Accelerate Development of Potential COVID-19 Hyperimmune Therapy
At the iHUB, we focus on disruptive innovation within our PDT Donor to patient ecosystem that not only focuses on the patients of today, but creates the pathway to meet the patients of tomorrow.Nat Arlander Head of the Plasma Innovation Hub in PDT
Our dedicated and specialized PDT R&D organization is uniquely positioned to support the entire patient experience. By challenging decades of established thinking and driving patient-centric innovations, we have the opportunity to have a tremendous impact on those who rely on plasma-derived therapies today and those who can benefit from them in the future.Kristina Allikmets Head of PDT, R&D
Working at Takeda
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Recognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
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