Cmc Lead

vor 7 Monaten

Wien, Österreich AOP Orphan Pharmaceuticals GmbH Vollzeit

Fulltime

Vienna

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 Lead (f/m/d).

**What Your Day To Day Will Look Like**:

- Responsible for process, product and analytical development and life cycle management
- Support continuous improvement in the technology, methodology, and AOPs processes used to enhance AOPs portfolio
- Recognize opportunities for cost and risk reduction
- Responsible for information for the CMC sections of regulatory submissions (CTD) and preparation of responses from health regulatory authority related requests
- Work with cross-functional teams, both internally and with external service providers (including CMOs & CLOs)
- Owns technical relationship with CxO(s)
- Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant stakeholder(s), and propose solutions
- Provide CMC input in due diligences and portfolio expansion opportunities
- Planning budget for assigned tasks

**Your Qualifications and Experience**:

- Higher degree in technical or scientific education, preferably chemistry, biotechnology or process engineering
- Background in CMC relevant topics, such as early and late-stage process, product, and analytical development and continuous improvement
- Preferably minimum 5 years of professional experience in a GMP environment (pharmaceutical production experience beneficial)
- Experienced in applicable EMA/FDA/ICH/WHO/ Global regulations
- Good critical thinking and analytical and problem-solving skills; back-ground in investigations, OOS, deviations and CAPAs a benefit
- Experience in regulatory submission highly desired
- Experience with health authorities a benefit
- 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

**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.

**Main Benefits**:
**Previous slide**

**Next slide**

**01**

**Flexibility**:
Flexible working hours

**02**

**Homeoffice**:
Take your focus when needed and stay connected.

**03**

**Training**:
Job training and further education

**04**

**Events**:
Afterwork, Team and All-Company events

**05**

**Health Check Offers**:
In-house health check offers, evaluations and vaccinations, year-round.

**06**

**Mobile Phone**:
Employee mobile phone

**07**

**Laptop**:
Company Laptop

**08**

**Canteen**:
Canteen on premises

**09**

**Transportation**:
Good connection to public transportation

**10**

**Parking**:
Parking spot

***

**HR Contact.**:
**Kathrin Breuer, BA, MA**

**kathrin.breuer[at]aoporphan**

**.**

**com**

**Kathrin Breuer, BA, MA**
**HR RECRUITER**

We’re committed to the highest standards of integrity, transparency, and accountability. We value the trust of our business associates, prospective partners, media, and interested parties who are not yet familiar with AOP Health.

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