(Senior) External Manufacturing Manager

Vor 3 Tagen

Wien, Österreich Valneva Vollzeit

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.

**Responsibilities**:
We are currently looking for a **(Senior) External Manufacturing Manager (M/F/d) **to join our team in** Vienna. **In detail you will be working on tasks such as:

- **Single point of technical contact** towards assigned External Partner’s and internal supporting departments amongst impacted (downstream & upstream) manufacturing sites
- Lead daily technical activities for **commercial manufacturing**, including technical reviews of EP process change requests and deviation reports
- Manage projects related to commercial vaccine production, including process improvements, capacity increases, and new product introductions
- Conduct **technical evaluations **such as Deviations and CAPAs
- Develop and implement production and product strategy, translating ExM/product strategy into executable technical plans
- Oversee **technical risk management** and product lifecycle, including tech transfer and product launches, ensuring development and adherence to technical risk management plans
- Identify and resolve technical issues, troubleshoot, and lead problem-solving efforts
- Manage Change Control, providing technical impact assessments for change controls and product complaints
- Review and approve documents like MBRs, risk assessments, qualification protocols, and CMC documents
- Drive process improvements in collaboration with other departments, acting as the primary technical contact for external partners and internal departments at **manufacturing sites**

**Requirements**:

- Demonstrated ability and expertise in supporting day-to-day activities related to functional technical operations in a cGMP manufacturing setting
- Several years of experience in **large-scale commercial pharmaceutical manufacturing**:

- Profound knowledge in formulation and process development of sterile injectable products with hands-on experience in a plant setting
- Experience working with external suppliers or within a **cross-functional**, matrix organization is desired
- **Leadership** skills: capable of leading and guiding others, especially in cross-functional teams
- Hands-on, results-oriented and dynamic team player with extensive project management skills
- Understanding of cGMP, post-approval changes, **ICH guidelines and regulatory validation**:

- Fluent in English, German is an add-on, willingness to travel

**Benefits**
- Open, appreciative company culture with innovative spirit and attractive assignments
- International surrounding with flat hierarchies
- Good team spirit in a strong and highly motivated team
- Wide range of benefits like flexitime, compensation days, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events, myClubs, full access to LinkedIn Learning,...
- Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 70.000;
- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience._

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