Sr. Research Associate Cmc

vor 3 Wochen

Wien, Österreich Takeda Pharmaceutical Vollzeit

**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 Sr. 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 for evaluating different medical devices for several commercial products for EU and Rest Of the World (ROW). You will be also responsible to support biological in-use studies with subvisible particle measurements and characterization. Beside that you will also support mechanical/functional testing during mechanical in-use studies. You will report to the Head of Device Drug Qualification & Compatibility VIENNA.

**Your Opportunity**:

- Investigate costumer device complaints (reconstitution devices, injection pens, needle safety devices and autoinjectors) of commercial products from EU and Rest of the World (ROW)
- Support device related biological in-use studies with characterization testing
- Support mechanical/functional testing during in-use studies related to insertion, aspiration and expel forces
- Use several equipment such as optical stereomicroscope, caliper, depth micrometer, ultrasonic cutter, digital camera and subvisible particle equipment (e.g. Light Obscuration, MFI, Flowcam) according to SOP or guidance documents
- Work closely with Market Surveillance (MS), Commercial Device Engineers (CDE) and Device Quality Assurance (DQA) during complaint investigations
- Be involved in device related in-use testing for clinical phase I to III and lifecycle management activities

**Accountabilities**:

- Independently collects and manages data and interpret data using existing standard procedures, digital platforms and software tools
- Identifies and communicates routine technical problems
- Investigate device complaints, draft and finalize investigation reports under Good Documentations Practices (finalize record in our “Trackwise” system)
- Decontaminate used devices if needed, before sending to external laboratories
- Coordinate with an external laboratories for vendor testing
- Arrange shipments of medical devices if required for further evaluations to the respective manufacturers, e.g. US, Taiwan, Canada, Germany, etc.
- Maintenance of equipment such as microscope and decontamination chamber
- Execution of subvisible particle characterization during biological device related studies (biological compatibility, in use, feasibility and comparability studies)
- Execution of functional testing (insertion, aspiration and expel force testing) during device related studies
- Support and execute method qualification studies and development experiments for Subvisible particles

**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
- Ability to work independently with mínimal supervision
- Strong attention to detail
- Team and result oriented, organizational ability
- Good communication skills when working with cross functional teams (MS, CDE and DQA)
- Good written and oral communications skills in English required, German desirable
- Basic knowledge of Statistics
- Time and resource management
- Associates degree and 4+ years relevant industry experience OR Bachelors degree and 2+ years relevant industry experience OR Masters degree and 0+ years 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 €3110,60 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

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