For a medium-sized biotech company with a clear focus on vaccines, we are currently looking for a Director Manufacturing (w/m/d) in southern Germany.
You will lead in a fast-moving environment, be able to bring in new ideas, structure, and vision, and will be a part of an up-and-coming biotech company.
Your Responsibilities:
* Ensure clinical manufacturing and industrialization of products and production process improvements as well as product portfolio extensions within the APU (Autonomous Production Unit).
* Disciplinary leadership of Production managers & teams for the production of mRNA active ingredients, pDNA, Master Cell banking, and formulated bulk according to GMP guidelines.
* Follow production plans and assure feasibility, making necessary corrective adjustments as needed.
* Monitor compliance with documentation requirements according to GMP.
* Oversee the qualification of premises and equipment as well as the validation of processes.
* Commit to and be accountable for delivering and pushing for speed/excellence in execution while not compromising on quality and safety.
* Develop long-term manufacturing strategy servicing the product portfolio.
* Achieve financial targets by preparing and presenting budget proposals including yearly cost improvements (e.g., yield) and managing the APU budget.
* Allocate appropriate resources within the budget perimeter.
* Manage the APU team by understanding the big picture of the manufacturing network, connecting the dots, and giving perspective and clarity to the team.
* Align resource planning with Supply Chain & Quality, Program Management, Engineering, and Technical Development departments concerning stocks, equipment, staffing, activities, etc.
* Maintain the working environment according to GMP & EHS standards.
* Share information transparently.
* Detect and plan training needs.
* Participate in career management initiatives.
* Serve as the official APU representative to regulators, customers (external or internal) and act as a business leader by navigating and influencing in a matrix organization.
* Ensure established customer specifications concerning cycle time, delivery, quality, quantity, and costs are met.
* Implement preventive and corrective measures in the production process to assure that compliance & customer demands are properly met.
* Coordinate with the quality team to meet all product standards.
* Drive continuous improvements in APU processes to raise quality, functionality/productivity, and to obtain CureVac & product project objectives.
Your Qualifications:
* Completed university degree with a pharmaceutical, bioengineering or scientific background or a comparable qualification.
* Extensive production experience and experienced people leader (several years team management experience) including larger teams and shift operations.
* Positive leadership with hands-on mentality.
* Experience in a regulated environment of a GMP manufacturing company, Leiter der Herstellung, §15 AMG.
* Knowledge of biotechnological methods such as TFF, HPLC, and transcription is advantageous.
* Operational knowledge of Lean methods (Kanban, 5S, Hoshin, Daily Performance Management) and shop floor management is desirable.
* Ability to influence heterogeneous and diverse teams in a matrix organization.
* Good MS Office skills and experience with process control systems are advantageous.
* Strategic thinking, Lean Mindset and strong communication skills.
* Fluency in English and German.
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Lebenslauf:
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Director Manufacturing - Biopharmaceuticals (w/m/d) (PR/4001473) Tübingen, Deutschland
Gehalt: EUR 120,000 - EUR 150,000 pro Jahr + verhandelbar.
Vielen Dank für Ihre Bewerbung.
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