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Job Description
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)
Serve on the Site Coordination Team to develop and deliver toward site and organizational priorities and strategy.
Manage and develop operations team personnel toward strong, empowered leaders. Build, inspire, reward and develop diverse talent with the capabilities necessary to succeed in manufacture.
Drive execution and operational excellence by applying Lean principles to foster continuous improvement mindset to deliver a productive and agile operating model.
Resolve resource and prioritization constraints and support resource needs and changes.
Management:
Drive a strong compliance mindset within the organization, including proactive safety and quality culture, and adherence to all regulatory expectations (GMP and EHS).
Establish and deliver on KPI’s in a timely manner, including schedule adherence, training, hiring, uptime, change controls, investigations, CAPAs, capital/expense targets, sustainability targets, yield/volume/cadence/operational availability, Right First Time, and timely documentation closure.
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.
Responsible for prioritization of proposed risk mitigation plans and/or acceptance of Quality Risks identified as part of the Quality Risk Management Process.
Provide clear direction and definition of any new project scope, goals and deliverables, to the site and functional teams on an on-going basis
Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site Stakeholders.
Manage financial forecasts and workload to achieve departmental headcount and pipeline deliverables
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 GMP drug substance manufacturing using mammalian cell culture, including upstream and downstream processing
Strong leadership and interpersonal skills, including leading and coaching direct team to drive a high-performance organizational culture that accommodates rapid growth & highly dynamic operating execution.
The desire to continuously learn, improve and grow, and cultivate continued development within the team
Experience in leading cross-functional teams (Manager of Managers)
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.
Current Contingent Workers apply
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