Director Manufacturing Operations
vor 2 Wochen
Job Description
Director Manufacturing Operations (m/f/d)
The Biotech facility embeds the latest technologies into the early stage clinical pipeline, helping to refine these technologies for inclusion into the late-stage and commercial launch of programs. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. Schachen Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline.
The Director Manufacturing Operations (m/f/d) leads an Operating Unit responsible for manufacturing biologics drug substance in an efficient and timely manner through application of state-of-the-art technologies for batch and continuous manufacturing with a Quality First, Safety Always Mindset. The Director Manufacturing Operations (m/f/d) leads teams responsible for Technology Transfer, Process Operations, and Support operations. The teams operate within a framework of regulatory compliance and established high standards of Quality, Good Manufacturing Practices (GMP) and Environmental Health & Safety protection. The Director Manufacturing Operations (m/f/d) shapes the direction of the pipeline by integrating an innovative/strategic focus and a high customer service level, fostering a strong performance orientation and effectively collaborating across the organization. He or she ensures a culture of self-direction, empowerment, and accountability, while providing the support necessary to team members working in a widely cross-functional organization.
The primary activities include but are not limited to the following:
Leadership:
- Sets performance targets that align with business priorities and drives continuous improvement initiatives.
- Develops the organization and culture (including values and behaviors such as empowerment, diversity, equity, and inclusion, accountability, trust, open communication).
- Drives a talent agenda: leads people processes through recruitment, training, coaching, and performance management to meet all operational requirements sustaining both global and local competitiveness and diversity.
- Establishes robust succession plans and drives talent retention.
- Builds and sustains strong networks in and outside the organization.
Management:
- Ensures that all aspects of operations within the facility comply with our compliance and safety policies and standards.
- Oversees planning and coordination of Manufacturing Operations activities including manufacturing and process technology transfers.
- Designs and operationalizes technology transfer processes that deliver right first-time manufacturing of biologics to support the pipeline.
- Manages the allocation of resources (including assets), costs, and investments efficiently.
- Responsible for budgets and management of unit costs, capital investments, and headcount.
- Contributes in his/her role within overarching business planning process driving towards fully integrated planning of clinical supply.
- Identifies and implements continuous improvement initiatives.
If you are passionate about leading innovative manufacturing operations and meet the qualifications listed, we encourage you to apply and join our dynamic team.
Required Education, Experience and Skills:
- Bachelor’s degree (B.S.) or equivalent in biology, chemical engineering, or a related discipline with at least 12 years or master’s degree (M.S.) with at least 10 years previous experience in a relevant position in GMP manufacturing in the pharmaceutical or biotech industry.
- Experience in drug substance manufacturing using mammalian cell culture, including upstream and downstream processing.
- Experience in leading cross-functional teams (Manager of Managers).
- Working knowledge of cGMP regulations.
- Demonstrated supervisory and leadership skills.
- Excellent oral/written communication skills in English (C1), and German (B2).
Preferred Experience and Skills:
- Qualification and training in economics and LEAN management.
- Experience with evolution of regulatory requirements.
- Experience with Cross-Functional Investigations and Root Cause Analysis Techniques.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Employee Status:
Regular
Relocation:
International
VISA Sponsorship:
Yes
Travel Requirements:
10%
Requisition ID:
R326868
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