Project Manager - Product Process Development

Job Detail

Our client, one of the world´s leading pharmaceutical company, is currently looking for their Project Manager – Product Process Development.

Your responsibilities:

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