Do you have drug substance manufacturing or chemical synthesis experience?
Invenia Group are partnered with a drug substance CMO in New Jersey, searching for a Senior Director of Operations to oversee the manufacturing of their intermediates.
Roles and responsibilities:
- Ensuring all processes are transferred into manufacturing in compliance with appropriate environmental regulations.
- Overseeing the safety of plant employees.
- Coordination of production activities.
- Implement process improvements to enhance cycle time, yield, labor utilization, efficiencies, process reliability, and production costs.
- Prepare and present summaries to plant management to demonstrate campaign status.
- Influence over potential maintenance works as well as analyzing site investment projects.
- Leading a team of our Senior Production Managers of Wet Trains, Physical Operations, and Cleaning Experts as well as our Team of Chemical and Physical Operations Operators.
- Implementation of process validations, equipment qualifications, and rework/reprocessing activities
- Coordination of new and changing wet train production
- Review and approve production-related deviations and investigations.
- Manage implementation and adherence to all applicable DOT, IATA, IMO, SHE, DEA, and cGMP regulations.
- Involvement in controlling strategic measurements and cost management.
Skills and experience required:
- A university degree in Chemical Engineering or Chemistry is preferred, and other related fields are also considered.
- Extensive experience in a similar position within a GMP environment.
- Drug substance manufacturing or chemical synthesis experience is essential.
- Strong understanding of Lean Six Sigma principles.
Sound interesting? Apply to find out more.
