Experience Senior (+5 years)
Our client, one of the world´s leading pharmaceutical company, is currently looking for their Project Manager – Product Process Development.
- Responsible to support new product introduction by developing new processes, evaluating existing processes, reducing costs and develop best practices.
- Develop and implement innovative solutions while maintaining reliable, safe, high-quality of products.
- Develop a culture of continuous improvement by innovative solutions.
- Management of a team of 5.
Key Activities & Accountabilities
- Provide technical leadership to identify, evaluate, improve and design process development strategies.
- Evaluate in collaboration with Manufacturing and Engineering groups if new or improved processes are compatible with manufacturing facilities and equipment.
- Provide support to new product introduction, production process development, product transfers, and existing process sustainment.
- Manage the design and execution of process development (Preparation, Synthesis, Dialysis, degassing filling, sterilization, final packaging) and appropriate Verification/validation activities accordingly applicable procedures and regulations.
- Manage the project development resources, including hiring, performance management, training and professional development, ensure PM tasks are delivered according to timelines and regulatory requirements.
- Write and perform Validation plan strategy and process validations in collaboration with Validation team including methods for inspection.
- Assess process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on commercial products.
- Work cross functionally with R&D, Manufacturing and Quality to optimize processes, address yield and quality issues.
Qualifications & Experience
- Engineering degree or equivalent, with at least 5-10 years confirmed experience in product development activities and project management in a regulated field
- At least 6+ years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation
- Industrial experience working in a GMP compliant setting
- Experience with regulatory filings for Medical Devices and supporting regulatory inspections
- Experience on statistic and SPC (Minitab)
- German – English speaking