Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
How will you make an impact?
Manage cGMP drug substance manufacturing in a state-of-the-art chemical API facility with ~ 130 m3 of total reactor volume and Highly Potent Compound capabilities. Utilize multi-purpose equipment to carry out chemical reactions, isolations, and drying operations to produce intermediates and active pharmaceutical ingredients for both clinical and commercial compounds in a safe and compliant manner.
What will you do?
• Manage all technical aspects of pharmaceutical drug substance production, including campaign preparation (e.g., process fits, process flow diagrams, process hazard analysis, etc.), oversight of daily production (e.g., batch operation of chemical reactions, isolations, drying, etc.), and closeout of manufacturing campaigns (e.g., campaign summary reports, equipment change-over / cleaning, etc.).
• Partner with lab scientists, business managers, and customers to plan campaigns, report results, and improve processes while focusing on the best solutions for our customers success.
• Drive continuous improvement in EH&S/Quality/Efficiency to ensure compliant, right-first-time production.
• Act as equipment and process owner for lifecycle documents such as P&IDs, criticality assessments, Quality Risk Assessments, Qualification/Validation documentation, and EH&S Process Hazards Analysis.
• Oversee production downtime activities including qualification, cleaning, maintenance, and calibration in close collaboration with all relevant stakeholders including Quality, Engineering, Maintenance, and Logistics.
• Oversee relevant compliance activities including discrepancy management, safety and quality investigations, and technical change management.
• Participate in audits and assessments as the Manufacturing representative and account for critical documentation used in regulatory (e.g., FDA, EMA, PMDA), 3rd party, and internal inspections. Define and ensure corrective actions resulting from inspections.
• Lead startup activities for new equipment installations.
• Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding, developing and disciplining employees; addressing complaints and resolving issues.
• Administer, document and maintain the Patheon Quality Systems and tools. Conform to regulatory requirements and company policies where appropriate through effective utilization of Patheon's Quality Systems and tools, as well as direct actions.
How will you get there?
• A Bachelor's degree in Chemical Engineering, Chemistry, or a related field.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.