Manager Impurity Programs

vor 2 Wochen

Wien, Österreich Takeda Pharmaceutical Vollzeit

**_ About the role:_**
- The Manager Impurity Programs will be part of the Takeda´s global initiative on nitrosamine impurities. The function will
- Coordinate and author regulatory communication
- Work on mitigating the emergent risk of formation of nitrosamine impurities in drug products by assessing the chemical formation of these impurities
- Develop mitigation strategies to analytically control and to avoid the formation of nitrosamine products.

**_ How you’ll make an impact/contribute:_**
- Author responses and scientific summaries for international Health Authorities
- Coordinate global activities for risk mitigation and analytics among different facilities of the Takeda network, customers and external laboratories
- Generate risk assessments and technical reports
- Oversee analytical method development for new impurities and external testing activities
- Actively participate in multidisciplinary teams to define investigation and risk mitigation activities
- Participate and actively collaborate in industry consortia.

**_ Minimum Requirements/ What you bring to Takeda_**
- Doctorate or Master degree in Organic Chemistry, Pharmaceutical Sciences or similar field with 5+ years of experience in the pharmaceutical industry.
- Experience in regulatory activities and communication with Health Authorities.
- Experience in working in GMP-compliant environment preferable.
- Strong scientific writing skills.
- Strong presentation skills.
- Excellent English skills, both written and spoken.
- Independent work, organizational thinking, critical judgment.
- Team-oriented, cooperative, communicative, conflict resolution skills, flexible, reliable.

**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 67

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

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