Description
Job DescriptionResponsible for providing technical oversight of biologics drug product manufacturing processes at CMOs (fill/finish). This position works closely with internal functions (Contract Manufacturing, Technical Development, Regulatory and Quality) and external service providers to ensure post drug substance processes perform as expected. Responsibilities include:
- Technology transfer of biologics drug product manufacturing processes (fill/finish) to contract manufacturing organizations (CMOs)
- Oversight of process validation activities associated with new and modified drug product processes
- Lead formal investigations to address manufacturing deviations or product complaints
- Provide routine commercial drug product support including exceptions resolution, change control, technical troubleshooting, etc.
- Provide technical support for drug product equipment and process changes being made at CMOs including review of change control/CAPA documentation
- Establish systems for tracking performance of drug product processes and report KPIs to management on a periodic basis
- Identify, assess and implement new technologies/process improvements for drug product processes in partnership with internal and external parties
- Author internal reports documenting technology transfer, validation, investigation, process improvement activities
Qualifications - Life Sciences or Engineering degree with experience.
- Subject Matter Expert in a core technical discipline.
- Degree with experience.
Technical expert in a core discipline. - Knowledgeable on core manufacturing operations (past experience supporting fill/finish manufacturing processes preferred)
- Excellent technical writing and presentation skills.
- Knowledgeable on Regulatory and Quality requirements
- Education B.S. plus 12 years of experience
- MS. plus 10 years of experience
- Ph.D. plus 6 years of experience
Please respond with your contact info and a word document format of your resume to b.ross(@)realstaffing.com to apply for an interview! Thank you for your time and interest!
To find out more about Real please visit www.realstaffing.com