Research Associate Cmc

**OBJECTIVES/PURPOSE**

Pharmaceutical Sciences (PharmSci) organization is an integral part of global R&D at Takeda translating science into therapeutic products for patients. When you join PharmSci, you become a part of a team dedicated to bringing our products to life for our patients through innovation, dedication and talent.

As a Research Associate CMC in the Device Drug Qualification & Compatibility team, a part of Drug Product and Device Development within Pharmaceutical Science, you will be responsible to support biological in-use studies for pipeline projects and life cycle management activities with subvisible particle measurements and characterization. You will report to the Head of Device Drug Qualification & Compatibility VIENNA.

**Your Opportunity**:

- Support device related biological in-use studies with subvisible particle (SVP) characterization testing for clinical phase I to III and lifecycle management activities
- Use several equipment such as subvisible particle equipment (e.g. Light Obscuration, Micro Flow Imaging (MFI), Flowcam, Nano Tracking Analysis (NTS) and AURA) according to SOP or guidance documents
- Environmental health and safety (EHS) representative within our team and closely collaborate with our local Austrian representative

**Accountabilities**:

- Independently collects and manages data and interpret data using existing standard procedures, digital platforms and software tools
- Identifies and communicates routine technical problems
- Maintenance of equipment such as MFI or Flowcam, pipettes and stop watches
- Execution of subvisible particle characterization during biological device related studies (biological compatibility, in use, feasibility and comparability studies)
- Support and execute method qualification studies and development experiments for subvisible particle characterization
- Makes basic experimental decisions within scope of responsibility
- Understands basic decisions made and able to discuss/communicate with supervisor and department members
- Contributes to technical reports, such as method qualification reports and/or device qualification reports

**Your Skills and Qualifications**:

- Has a basic understanding on medical devices related to different offered forms of the drug (lyophilized, liquid) and administration routes (IV, SC,...) with all pros and cons during handling these medical devices
- Works with department peers to execute and coordinate activities for well defined assignments independently
- Team and result oriented, organizational ability
- Good written and oral communications skills in English required, German desirable
- Basic knowledge of Statistics
- Time and resource management
- Associates degree and 2+ years relevant industry experience
- Bachelors degree and some relevant experience

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 € 3.110,60 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