Senior External Manufacturing Manager for Commercial Vaccine Production
Vor 5 Tagen
Company Overview:
We are looking for a highly skilled professional to take on the role of Senior External Manufacturing Manager Technology Fill & Finish in our international biotechnology company. As a key member of our team, you will play a vital part in ensuring the success of our commercial vaccine production operations.
Compensation:
The estimated annual salary for this position is €70,000 (excluding bonus). Depending on your qualifications and experience, we offer the possibility of overpayment.
Job Description:
- Technical Leadership: As Senior External Manufacturing Manager Technology Fill & Finish, you will serve as the single point of technical contact towards assigned external partners and internal supporting departments. Your primary responsibility will be to lead daily technical activities for commercial manufacturing, including technical reviews of EP process change requests and deviation reports.
- Project Management: You will manage projects related to commercial vaccine production, including process improvements, capacity increases, and new product introductions. This will involve conducting technical evaluations, such as deviations and CAPAs, and developing and implementing production and product strategies.
- Risk Management: In this role, you will oversee technical risk management and product lifecycle, including tech transfer and product launches. You will ensure development and adherence to technical risk management plans.
- Troubleshooting and Problem-Solving: As Senior External Manufacturing Manager Technology Fill & Finish, you will identify and resolve technical issues, troubleshoot, and lead problem-solving efforts.
- Change Control: You will manage Change Control, providing technical impact assessments for change controls and product complaints. Additionally, you will review and approve documents like MBRs, risk assessments, qualification protocols, and CMC documents.
- Process Improvements: In collaboration with other departments, you will drive process improvements, acting as the primary technical contact for external partners and internal departments at manufacturing sites.
Required Skills and Qualifications:
- Education: A university degree is required for this position.
- Experience: Several years of experience in large-scale commercial pharmaceutical manufacturing are necessary. Profound knowledge in formulation and process development of sterile injectable products with hands-on experience in a plant setting is also required.
- Leadership and Project Management: Experience working with external suppliers or within a cross-functional, matrix organization is desired. Leading and managing cross-functional teams on a project basis is essential.
- Technical Expertise: Hands-on, results-oriented, and dynamic team players with extensive project management skills are preferred. Understanding of cGMP, post-approval changes, ICH guidelines, and regulatory validation is also necessary.
- Languages: Fluency in English is required, and German is a plus. Willingness to travel is also necessary.
Benefits:
- Diverse Range of Tasks: We offer a diverse range of tasks in a newly created position.
- Possibility to Shape Company Success: You will have the possibility to actively shape the company's success.
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