Senior External Manufacturing Manager in Technology Fill
vor 4 Wochen
Our client is a specialized player in the life science sector and a leader in his field. The company is characterized by its fast-paced environment, innovative approach, and strong team spirit.
If you are a formulation & aseptic filling expert take your chance for the following business-critical position, which is to be filled with immediate effect:
Senior External Manufacturing Manager in Technology Fill & Finish (f/m/x)
Location: Vienna
Aufgaben
- 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
Profil
- 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 an add-on, willingness to travel
Wir bieten
- Successful and growing company with an attractive product portfolio and a promising pipeline
- Diverse range of tasks in a newly created position
- Possibility to actively shape the company's success
The compensation of this position consists of a gross annual salary of € 85.000 (excluding bonus). Overpayment is possible and depends on your qualifications and work experience.
JBG81_AT
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