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As international as a corporation, as personal as a medium-sized business: this is the culture at Biotest. As a global specialist in immunology and haematology, our mission is called “saving lives”. We give new perspective to chronic illnesses with innovative products and groundbreaking research. Motivated employees are therefore essential. Individual promotion and development prospects are part of everyday life for us. Join a team of 2,700 employees with great ideas.
Aufgaben
* Design and execute a comprehensive manufacturing strategy aligned with organizational objectives, ensuring the efficient and compliant production of plasma-derived therapeutics
* Lead and manage all aspects of manufacturing operations, with a focus on process optimization, production scheduling, and efficient resource utilization, to ensure the achievement of target output and performance metrics
* Ensure full compliance of all manufacturing operations with applicable regulations and industry standards, including FDA, EMA, and cGMP guidelines. Lead and oversee preparations for successful regulatory audits and inspections
* Build and lead a diverse, high-performing manufacturing team by fostering a culture of accountability, continuous improvement, and professional growth. Mentor team members to develop their skills and maximize performance
* Cross-Functional Collaboration - Collaborate closely with teams of maintenance, quality assurance, supply chain, and regulatory affairs teams to drive product development initiatives and accelerate the commercialization of new therapies
* Establish and track key performance indicators (KPIs) for production efficiency, quality, and cost-effectiveness, utilizing data analytics to drive informed decision-making and continuous improvement
* Lead the adoption of innovative technologies and methodologies to enhance manufacturing processes and product quality, with a focus on automation and digital transformation initiatives
* Stakeholder for the scaling and ramp-up of the manufacturing plant, proactively defining organizational, process, and equipment measures in collaboration with established project teams
Profil
* Completed Master degree in Engineering, Life Sciences, or a related field
* Minimum of [10+] years of experience in manufacturing leadership roles within the biopharmaceutical or plasma industries
* Strong experience in upstream and downstream processes, purification techniques, and analytical methods relevant to the industry
* Strong knowledge of daily manufacturing monitoring, performance indicators, staffing models, cultural changes, cost controlling
* Regulatory Knowledge, in-depth understanding of global regulations governing plasma-derived products, including risk management and quality assurance principles
* Demonstrated ability to lead, influence, and develop large teams while driving a culture of safety, quality, and performance excellence
* Exceptional communication and collaboration abilities, with a proven record of fostering productive relationships across all organizational levels
* Fluency in both German and English at a very good level
Wir bieten
* Flat hierarchies and pleasant working environment
* Individual training program
* Attractive remuneration
* Corporate benefits (discounts for our employees)
* Canteen and meal allowance
* Day care center "BioNest"
* Further education and training
* Free parking garage for our employees incl. charging facilities for your e-car
Important note
Please be advised that a valid work permit for Germany is required for non-EU citizens. Unfortunately, applications without a valid work permit and sufficient German language skills may not be considered.
Beschäftigungsverhältnis
* Vollzeit
Tätigkeitsbereich
* Management und Fertigung
Branchen
* Fertigung
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