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Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Operations Director will oversee the management of all manufacturing operations and MSAT departments for CT and Palsmid products, with a key focus on results in terms of delivery, quality, safety, and cost.
In addition, they will be responsible for GMP translation, technology transfer, and validation of manufacturing processes and associated analytical methods. They are expected to have a comprehensive understanding of Cell Therapy CMC activities and to drive innovative solutions for early and late-stage client programs.
The Operations Director reports to the General Manager and is an active member of the site leadership team. Senior Production Partner, MSAT Senior Manager, and Supervisor staff members report to this function.
The Role:
Responsible for the daily operation of the production (operations) and MSAT departments, ensuring that business operations (production and industrialization) are efficient and effective (quality, cost, delay, safety). This includes managing resources, distributing goods and services to customers, and analyzing queue systems to define an appropriate CAPA plan.
Work closely with Project Management, Quality Control, and within MSAT/Operations to ensure successful transfer of processes and analytics from P&AD and/or clients into manufacturing and validations to support early phase through commercial manufacturing activities.
Develop and cascade the organization’s strategy/mission statement to lower-ranking staff, implementing appropriate rewards, recognition, coaching, and corrective practices to align personnel with company goals.
Maintain the plant at the required level to produce in cGMP conditions; lead shutdowns and plant expansions.
Ensure operational documents are complete, current, compliant with regulatory requirements, and stored appropriately.
Elaborate and manage the strategy and direction of the operations and MSAT teams to ensure necessary improvements and upscaling when required.
Maintain and monitor staffing, knowledge, skills, attributes, expectations, and motivation to fulfill organizational requirements. Recruit, lead, and develop the team.
Other duties as assigned.
The Candidate:
At least a Bioengineering degree or master’s degree in biology, pharmacy, chemistry, agronomy, etc.
At least 15 years’ experience in a cGMP biopharmaceutical environment, including people management and manufacturing.
Team leader, excellent communicator, quality-minded, and customer-oriented.
Familiar with Operational Excellence principles.
Fluency in English and French.
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