Downstream Manufacturing and Fill/Finish Lead Scientist
Scope of Function:
Working as a part of GMP Downstream Manufacturing Staff to plan and execute purification and conjugation of biologics for clients. Partner with
Process Development staff to assist in technical transfers. Lead cGMP Filling Operations; Planning and execution of final vial filling operations including filling validation runs.
Responsible for all GMP filling activities
Write, review and/or approve documents such as Batch Records, SOPs validation reports and exception documents.
Collaborate with Facilities Department to ensure manufacturing equipment and filling suites are maintained and ready for fill activities.
Ensure that operators are properly trained for filling tasks.
Assist and participate in Downstream cGMP activities including but not limited to column chromatography, UF/DF, filtration, and ultracentrifugation processes.
Partner with Process Development staff in the Technical Transfer for Process transfer.
Education, Experience and Skills Required:
Education : Bachelors Degree in Biological Sciences, Chemistry or related field.
Experience : A minimum of 5 years experience in cGMP manufacturing and aseptic filling operations. Experience with semi-automated and automated filling equipment and validation of equipment.
- Upstream and Downstream Manufacturing, Facilities, Project Management, Quality Control, Quality Assurance, Materials Management