Andrew Cable Email & Phone Number

Livermore, Ca, Us

Emeryville, California, Us

• GMP manufacturing process experience includes plasmid digest/DNA cleanup, Transfection, and amplification ofChimpanzee Adenovirus with HEK293 cell cultures in single use systems. Harvest and purification experience withAEX chromatography, TFF, and sterile filtration. Fill qualified and experienced with PF6 manual filling and VANRXautomated filling.• Acted as Upstream SME on new process introduction including authoring tech transfer and comparability reports,change controls, IND submissions, process lock activities, bioreactor process optimization, kaizen events, etc.• Project manager for automated environmental monitoring system, tech transfer of automated purification skid, Mediafill/Aseptic qualification process optimization, Full EBR piloting and implementation, and Working cell bankproduction process implementation.• Managed scheduling of process runs coordinating with multiple functional groups on timelines.• Review of BOM for annual budgeting, COG reductions, and cGMP compliance.• Provided employee feedback and evaluations for performance reviews and coaching development.• Investigated Deviations; owned and implemented CAPAs

Emeryville, California, Us

Ingelheim Am Rhein, Rhineland-Palatinate, De

• Aseptically qualified to work in Biosafety Cabinet; daily experience doing GMP production CHO cell culture transferssmall scale.• Cell Culture operator for large scale production bioreactors including inoculation, culture transfers, general CIP/SIPprocedures, and harvest.• Audit experience presenting to FDA/ clients and answering IRFs in audit room.• Collaborated with multiple groups on projects including: Cell Inoc Process FMEA, Cell bank shipping processimplementation, Full EBR testing, and Validation Projects.