Cmc Analytical Lead

vor 3 Wochen

Wien, Österreich AOP Orphan Pharmaceuticals GmbH Vollzeit

AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team in Vienna we are looking for a:
**CMC Analytical Lead (f/m/d)**:

- 1190 Vienna
- Full-time employee
- min. 63.000;
- (gross/p.a.)

**What Your Day To Day Will Look Like**
**- Develop phase-appropriate analytical methods across three main areas:

- Characterization and comparability
- Non-routine and release/stability use
- In-process analytics
- Coordinate and manage method validation and method transfers
- Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant stakeholders (s), and propose solutions
- Demonstrate creativity, problem-solving and critical thinking skills to overcome potential challenges
- Work with cross-functional teams, both internally and with external service providers (including CMOs & CLOs)
- Provide CMC input in due diligences
- Contribute to drafting regulatory filing documentation

**Your**
**Qualifications and Experience**
**- Higher degree in technical or scientific discipline, preferably chemistry, or equivalent work experience
- Preferably minimum 2 years of professional experience in a GMP environment
- Experienced in applicable EMA/FDA/ICH/WHO/ Global regulations
- Good verbal, presentation, and written communication skills in English and basic German skills
- Capable of conveying technical and project information in a concise and clear manner
- Good interpersonal and organizational skills
- Demonstrated ability to work well in interdisciplinary team
- The ability to manage outsourced projects with external vendors

**Our Offer**
**- Open corporate culture with the opportunity to bring in your own ideas
- Great opportunities for personal and professional development
- Attractive work environment with excellent career opportunities and flat hierarchies
- Competitive salary package plus bonus and various benefits
- Structured onboarding and a buddy system
- Gross monthly salary provided for this function is a minimum of EUR 4.500. based on full-time employment. Any potential overpayment depends on professional experience and qualifications.
- If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative"_
- _

**Introduction**:
**Main Benefits**:

- Bonus- Homeoffice- Employee mobile phone- Flexible working hours- Laptop- Initial and continuing education- Canteen- Good transport connection- Employee events- Company doctor- Parking spot- Healthmeasures**Your Contact**:
***

**Kathrin Breuer**

***

***

**+436766986255**

***
- Further information on our website:_

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