Analytical Development Representative

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:
**Your Opportunities**:

- 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.

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

**Locations**:
AUT - Wien - Industriestrasse 72

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time