We are seeking a highly motivated and experienced Senior Manager / Manager Manufacturing Fill & Finish to lead the aseptic manufacturing activities on a state-of-the-art multi-format filling line (vials, syringes, and cartridges) operated under isolator technology. The role includes a strong project phase involvement as System and Area Owner and will evolve into full operational responsibility as leader of the Fill & Finish team. This position requires a solid background in aseptic filling manufacturing, GMP Operations, operational excellence and people management.
Project Phase:
- Act as System Owner for the installation and qualification of the new filling area, aseptic filling line and related surrounding process equipment
- Responsible to define and implement the operational procedures (SOPs) for aseptic activities under isolator.
- Define material introduction processes in clean rooms, set-up, filling batches, and set-down operations.
- Support APS protocols preparation and execution of protocols and reports in collaboration with validation and QA teams.
- Participate in visual inspection activities definition and support visual inspection readiness.
Operational Phase:
- Manage, plan, lead all GMP productions
- Oversee day-to-day aseptic filling operations, ensuring adherence to GMP, safety, and quality standards.
- Manage the planning and scheduling of filling activities, ensuring resource optimization and batch readiness.
- Ensure compliance with all applicable procedures, regulations, and internal quality systems.
- Assess and investigate events, deviations and non-conformances in Fill & Finish manufacturing activities
- Operational budget defintion and follow-up
- Define and maintain KPI for Fill & Finish activity regarding EHS, quality, operational performance and support the tracking of Manufacturing performance metrics
- Drive continuous improvement initiatives focused on efficiency, compliance, and safety.
- Support new process and new formats implementation, including APS.
- Lead and manage Change Controls and deviations including any corrective actions
- Proactively propose problem resolution to process
- Execute and support development/ equipment qualification/ validation activities for new equipment/ new process
- Representative as SME during GMP inspection
- Provides technical leadership for DP Manufacturing
- Remain current on latest industry standards
- Ensure safe working conditions
- Contribute positively to a strong culture of business integrity and ethics
- Lead local improvements projects and initiatives in collaboration with other Bioplant departments and Global functions
- Provide appropriate reporting in term of quality and frequency
- Act actively to the people development
- Act within compliance and legal requirements as well as within company guidelines
People Management:
- Lead, develop, and coach a team of operators and supervisors.
- Promote a culture of ownership, collaboration, and accountability within the team.
- Ensures staff is sufficiently trained to perform their job responsibilities
- Conduct regular performance reviews and career development discussions.
- Foster strong communication and cross-functional collaboration.
REQUIREMENTS
- Degree in Life Sciences, Engineering, or related field, or equivalent combination of education, training, and relevant experience.
- Significant experience in aseptic manufacturing, preferably with isolator technology (typically demonstrated by 10+ years in the field, or an equivalent combination of education, training, and experience)
- Experience in project management and installation/start-up of manufacturing equipment.
- Demonstrated leadership and team management skills.
- Strong knowledge of GMP and regulatory requirements.
- Strong experience in projects with good knowledge of Design, Construction & C&Q activities
- Excellent communication and stakeholder management abilities.
- Strong interpersonal and communications skills; written and oral
- Fluent in English and French
- Travelling may be required
- Broad knowledge of Pharmaceutical Quality, Manufacturing, GLP/GCP/GMP/GAMP practices and Annex 1 requirements
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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