External Manufacturing Manager Technology Fill
vor 4 Wochen
Take on a challenging role in a dynamic biotechnology company.
Our client is a leading player in the life science sector, characterized by its fast-paced environment, innovative approach, and strong team spirit.
If you are a formulation and aseptic filling expert, consider this business-critical position:
Senior External Manufacturing Manager Technology Fill & FinishYour Key Responsibilities:
- Act as the single point of technical contact for assigned external partners and internal supporting departments.
- 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:
- University degree.
- 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 a plus, willingness to travel.
Our Client Offers:
- A successful and growing company with an attractive product portfolio and a promising pipeline.
- A diverse range of tasks in a newly created position.
- The possibility to actively shape the company's success.
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.
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