Senior External Manufacturing Manager Technology Fill &…

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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:

• Single point of technical contact towards assigned external partners 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

• 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

• 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 for this position consists of a gross annual salary of € 85.000 (excluding bonus). Overpayment is possible and depends on your qualifications and work experience.

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