External Manufacturing Manager Technology Fill Specialist
vor 3 Wochen
Are you a seasoned professional in large-scale commercial pharmaceutical manufacturing? Do you have a strong background in formulation and process development of sterile injectable products? We are seeking an experienced External Manufacturing Manager Technology Fill to join our team at Talentor Austria GmbH.
Key Responsibilities:- 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.
- 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.
Talentor Austria GmbH is a successful and growing company with an attractive product portfolio and a promising pipeline. We offer a diverse range of tasks in a newly created position and 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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Wien, Wien, Österreich Talentor Austria GmbH VollzeitJob Title: External Manufacturing Manager Technology FillWe are seeking an experienced External Manufacturing Manager Technology Fill to join our team at Talentor Austria GmbH. As a key member of our organization, you will be responsible for leading daily technical activities for commercial manufacturing, including technical reviews of EP process change...
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Wien, Wien, Österreich Talentor Austria GmbH VollzeitJob Title: External Manufacturing Manager Technology FillOur client, a leading player in the life science sector, is seeking an experienced External Manufacturing Manager Technology Fill to join their team. This is a business-critical position that requires a strong technical background and leadership skills.Key Responsibilities:Act as the single point of...
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Wien, Wien, Österreich Talentor Austria GmbH VollzeitJob Title: External Manufacturing Manager Technology FillWe are seeking an experienced External Manufacturing Manager Technology Fill to join our team at Talentor Austria GmbH. As a key member of our organization, you will be responsible for leading daily technical activities for commercial manufacturing, including technical reviews of EP process change...
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