A Pharmaceutical Manufacturing Specialist supports production operations, product introductions, and process transfers in a regulated biologics facility. They provide technical guidance, process monitoring, and hands-on assistance to ensure safe, compliant, and efficient manufacturing.
Key Responsibilities
1. Perform gap analysis, facility suitability studies, process safety evaluations, and risk assessments for new product introductions.
2. Monitor and analyze process data during manufacturing to identify trends and support issue resolution.
3. Collaborate in the development and optimization of manufacturing processes for new and existing products.
4. Prepare, update, and maintain specifications, protocols, procedures, transfer plans, and manufacturing batch records related to NPI activities.
5. Provide operational technical support, including troubleshooting during drug product fill-finish operations.
6. Lead and/or assist risk assessments such as PFMEA and EHS evaluations.
7. Assist and/or lead investigations, change plans, and process-related problem solving.
8. Support, supervise, and train production personnel for NPI and drug product processes.
9. Work closely with global science, quality, MS&T, and development groups on process development and technical transfer.
10. Ensure adherence to EHS standards, cGMP expectations, HPRA/FDA requirements, and site procedures.
11. Support cross-functional teams and cost-improvement initiatives, providing technical expertise to daily operations.
12. Operate with high autonomy and escalate significant decisions to the NPI Technical Manager when required.
13. Provide technical support for drug product fill-finish operations for biologics products.
14. Support processes involving lyophilized drug product.
15. Lead or support technical transfer deliverables, including gap assessments and cleaning assessments.
16. Work with drug product processes designed with single-use technologies.