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Sterile Product Specialist
vor 1 Monat
Talentor Austria GmbH is a leading player in the life science sector and a specialist in biotechnology. Our company is known for its fast-paced environment, innovative approach, and strong team spirit.
Estimated Salary
The compensation for this position consists of a gross annual salary of € 70,000 (excluding bonus). Overpayment is possible and depends on your qualifications and work experience.
Job Description
Synopsis:
This role involves serving as a single point of technical contact towards assigned external partners and internal supporting departments amongst impacted manufacturing sites. The successful candidate will lead daily technical activities for commercial manufacturing, including technical reviews of process change requests and deviation reports.
Key Responsibilities:
- Lead technical activities for commercial manufacturing
- Manage projects related to commercial vaccine production
- Conduct technical evaluations such as deviations and CAPAs
- Develop and implement production and product strategy
- Oversee technical risk management and product lifecycle
- Identify and resolve technical issues
- Manage Change Control
- Review and approve documents like MBRs, risk assessments, qualification protocols, and CMC documents
Required Skills and Qualifications
To be successful in this role, you will need:
- University degree
- Several years of experience in large-scale commercial pharmaceutical manufacturing
- Profound knowledge in formulation and process development of sterile injectable products
- Hands-on experience in a plant setting
- Experience working with external suppliers or within a cross-functional, matrix organization
- Leading and managing cross-functional teams on a project basis
- 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 a plus, willingness to travel
Benefits
We offer a diverse range of tasks in a newly created position, possibility to actively shape the company's success, and an attractive product portfolio with a promising pipeline.
