Senior Product Stability Specialist

vor 2 Wochen

Wien, Österreich Takeda Pharmaceutical Vollzeit

**About the role**:
As a Senior Product Stability Specialist, you will be in charge of various projects linked to Stability Studies for Drug Products, Drug Substances and Intermediates.

**How you will contribute**:

- Project Management of Stability Studies for Drug Products, Drug Substances and Intermediates as well as associated Data Evaluations and Documentation
- Assignment and continuous Monitoring of product shelf life
- Authoring of technical documents for regulatory submissions
- SME guidance for regular SMEs
- Management of stability studies for assigned products
- Generation of stability protocols and stability reports (e.g. final reports, PQRs, annual reports)
- Authoring and review of stability sections for regulatory submissions

**What you bring to Takeda**:

- High school degree and several years of work experience preferably in pharmaceutical or associated industry
- Bachelor/ Master Degree in Science or Engineering or several years of Experience in pharmaceutical Industry Science related degree is preferred
- Knowledge and understanding of ICH and other regulatory requirements.
- Knowledge and ability to author technical documents
- Experience with various quality systems (e.g. investigations, CAPAs and change controls)
- Fluent in English (written and oral)
- Self-independent work attitude

**What Takeda can offer you**:
A competitive remuneration package with a minimum salary of € 3.909,67 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.
- Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten
- Comprehensive training programs
- In-house job rotation program
- In-house Canteen with discounts or meal vouchers
- Works council (events, festivals, shopping vouchers, etc.)
- Employee Referral Program
- Employee Recognition Program
- Takeda Resource Groups
- Medical checkups
- Free vaccination program
- Fitness Center

**More about us**:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

**Empowering our people to shine**:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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

**Worker Type**:
Employee

**Worker Sub-Type**:
Fixed Term (Fixed Term)

**Time Type**:
Full time

  • (Senior) Specialist Stability Studies- Quality

    vor 3 Wochen

    Wien, Österreich HOOKIPA Biotech GmbH Vollzeit

    **About HOOKIPA**: HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T cells to address unmet needs in cancer. This leveraging its proprietary, versatile platform to engineer a broad pipeline of differentiated arenaviral therapeutics. These novel...

  • Global Product Stability Specialist

    vor 3 Wochen

    Wien, Österreich Takeda Pharmaceutical Vollzeit

    **About the role**: **How you will contribute**: - Stability management of biotechnological products - Planning, coordination and management of projects within global teams - Preparation and review of technical documents for regulatory submissions - Participation in stability OOS investigations - Working with document management systems and databases -...

  • Global Stability Project Management Specialist

    vor 2 Wochen

    Wien, Österreich Takeda Pharmaceutical Vollzeit

    **About the role**: The "Global Stability Project Management Specialist" will be in charge of process harmonization projects and integration activities and will drive compliance & continuous improvement initiatives for the department. How you will contribute: - Project management of global projects for stability study management for the optimization of...

  • Senior Product Specialist Wien

    Vor 7 Tagen

    Wien, Österreich Syneos Health Commercial Solutions Vollzeit

    **Overview** **As a dedicated Syneos Health Senior Product Specialist, you will implement the clients' go-to-market strategy by delivering sales presentations to prospective customers. In the assigned territory, you will be expected to engage with HCP's and Pharmacists within a hospital setting using bespoke material designed for a respective audience....

  • Senior Product Specialist Wien

    Vor 7 Tagen

    Wien, Österreich Syneos Health Clinical Vollzeit

    **Overview** **As a dedicated Syneos Health Senior Product Specialist, you will implement the clients' go-to-market strategy by delivering sales presentations to prospective customers. In the assigned territory, you will be expected to engage with HCP’s and Pharmacists within a hospital setting using bespoke material designed for a respective audience....

  • Stability Project Management Specialist

    vor 1 Woche

    Wien, Österreich Takeda Pharmaceutical Vollzeit

    **Über die Rolle**: In dieser spannenden Rollen übernehmen Sie die Verantwortung für die Planung und Durchführung von Stability Studien für lokale Produkte. **Das bewirken Sie**: - Erstellen und Ownen von Stability Studienplänen - Zeitgerechte Erstellung und Versand von Sample Requests - Erstellung und Pflege von Stability Studien im Stability Lims -...

  • Senior Digital Products

    vor 2 Wochen

    Wien, Österreich Western Union Vollzeit

    **Senior Digital Products & Customer Success Specialist** **- Vienna, Austria** Would you like to work for an organization that strives to provide a better customer experience in the product offering, standards, and processes? Are you ready to take on senior responsibilities in a truly global environment? Join Western Union as a Senior Digital Products &...

  • Senior Team Manager, Technical Product Consultants

    vor 2 Wochen

    Wien, Österreich Dynatrace Vollzeit

    Company Description Are you looking for a fast-paced environment where you can blend your technical curiosity and experience with your passion for helping others (in this case, our customers) succeed in overcoming some of their biggest digital transformation challenges? If so, look no further. We want to talk to you! Dynatrace ONE is Dynatrace’s name for...

  • Product Support Specialist

    vor 1 Woche

    Wien, Österreich OneSpan Vollzeit

    At OneSpan, we're reimagining trust to help businesses to thrive by enabling secure, compliant, and frictionless digital agreements and transactions. Across the globe, we are trusted by global enterprises, including more than 60% of the world's largest 100 banks, to enrich their customer experience and mitigate threats today, while preparing to take full...

  • Senior Validation Specialist

    vor 2 Wochen

    Wien, Österreich Takeda Pharmaceutical Vollzeit

    **About the role**: As Senior Validation Specialist, you will be part of the local PS (Process Science) - MSV (Manufacturing Sciences Vienna) team, responsible for controlling of the process stability and evaluation of product quality. You will be in charge of developing validation strategies and their operative execution as well as be in close contact with...

  • Product Specialist

    vor 3 Wochen

    Wien, Wien, Österreich Auer Signal GmbH Vollzeit

    Product Specialist (w/m/x) Wir sind ein international erfolgreiches, familiengeführtes Industrieunternehmen, wir entwickeln, produzieren und vertreiben optische und akustische Signalgeräte. 98% unserer vielfältigen Produkte gehen in den Export. Unser Erfolg hängt vor allem an unseren Mitarbeiter:innen, die in hoher Eigenverantwortung die Produkte von...

  • Technical Product Specialist

    vor 3 Wochen

    Wien, Wien, Österreich ANGEHEUERT Recruiting Vollzeit

    Als Technical Product Specialist brennst du für Requirements, Softwarearchitektur und Programmiersprachen wie PHP? Dann bleib dranUnser Kunde ist ein internationales Software-Unternehmen mit Fokus auf eCommerce und digital payment transactions. Von A1 über Allianz bis zu ÖAMTC und Marrionaud – renommierte Kunden aus unterschiedlichsten Branchen...

  • Technical Product Specialist

    vor 2 Wochen

    Wien, Österreich Dynatrace Vollzeit

    **Company Description**: Are you looking for a fast-paced environment where you can blend your technical curiosity and experience with your passion for helping others (in this case, our customers) succeed in overcoming some of their biggest digital transformation challenges? If so, look no further. We want to talk to you! The world needs perfect software...

  • Senior Product Manager

    vor 3 Wochen

    Wien, Wien, Österreich at Vollzeit

    Product Management & Development (Marketing & Communications)Senior Product Manager – Lead Transformational Change in Managed Investment SchemesAre you ready to drive transformational change and deliver meaningful results?We are exclusively recruiting for a Senior Product Manager role with a leading organisation in Wealth & Capital Markets, renowned for...

  • Senior Specialist Corporate Development

    vor 3 Wochen

    Wien, Wien, Österreich STRABAG SE Vollzeit

    Strabag AG Senior Specialist Corporate Development - New Business Models (m/f/d) Wien Vollzeit req66018 Aufgaben The team is responsible for identifying and evaluating new business opportunities, find product-market fit for business model hypotheses and hands-on venturing. You will be part of STRABAG's Corporate Development team, conquering...

  • Product Sustainability Specialist

    vor 1 Woche

    Wien, Österreich MM Group Vollzeit

    **Req ID**:1229 **Full-Time/Part-Time**:Full-Time **Our heart beats for talents - be one of them!**: To strengthen our passionate **Group Sustainability Team **we are looking for an ambitious and open-minded **Product Sustainability Specialist (M/F/d) **to support and drive a wide range of sustainability activities on an international level. **Your...

  • Payroll/Awards Implemention Specialist

    vor 3 Wochen

    Wien, Wien, Österreich at Vollzeit

    Payroll/Awards Implementation Specialist | Health Industry (2cloudnine Software)Exclusive Role to Boyd Recruitment - This is more than just any job - this is your next big opportunity to really make a differenceThis rare and exciting newly created role offers a career within a thriving business that has been shaping the Australian Health Industry.Our client,...

  • Senior Technical Sales Specialist

    vor 2 Wochen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    **Job Title: Senior Technical Sales Specialist - Rapid DNA Platform** **Requisition ID: 195323BR** When you are a part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With...

  • Product Return Specialist

    vor 3 Wochen

    Wien, Wien, Österreich SAMSUNG Electronics Austria GmbH Vollzeit

    Product Return Specialist - Karenzvertretung (w/m/x) Samsung Electronics gestaltet die Zukunft mit Ideen und Technologien, die unser tägliches Leben verbessern. Von Fernsehern über Smartphones bis hin zu LED-Lösungen - es ist unser erklärtes Ziel, Menschen auf der ganzen Welt zu inspirieren. Teilst du unsere Vision? Dann lass uns gemeinsam Großes...

  • Product Return Specialist

    vor 4 Wochen

    Wien, Wien, Österreich SAMSUNG Electronics Austria GmbH Vollzeit

    Product Return Specialist - Karenzvertretung (w/m/x) Samsung Electronics gestaltet die Zukunft mit Ideen und Technologien, die unser tägliches Leben verbessern. Von Fernsehern über Smartphones bis hin zu LED-Lösungen - es ist unser erklärtes Ziel, Menschen auf der ganzen Welt zu inspirieren. Teilst du unsere Vision? Dann lass uns gemeinsam Großes...