Kyle Mcculloch Email & Phone Number

Thousand Oaks, Ca, Us

 Managed different facets of commercial launches of multiple jurisdictional SKUs manufactured/packaged out of a partner CMOs.  Coordinated complex investigations ensuring completion of key actions to adhere to target due dates. Led internal/external cross-functional teams using WCT tools for clear accountability of actions while ensuring quality, cost, and delivery. Facilitated component and artwork changes with cross-functional teams internally and externally. Owned quality records including change controls, minor/major deviations, CAPA’s, and Supplier Investigation/Corrective Action Requests (SICAR). Managed Purchase Orders and Change Orders for Clinical and Commercial programs.

Thousand Oaks, Ca, Us

Quality Record owner for Change Controls, CAPAs, Deviations, and Supplier related notifications. Management and oversight of Purchase Orders and changes to the scope of work for Amgen’s Contract Manufacturing group and Contract Manufacturing Organizations.Meeting owner and facilitator for Amgen’s Contract Manufacturing Group and for joint meetings with CMOs related to Synthetics DS.Project Manager for Clinical and Commercial Synthetics Drug Substance projects at Contract Manufacturing Organizations.

Thousand Oaks, Ca, Us

Shift Lead role for team, which includes but is not limited to troubleshooting issues in the manufacturing area, assigning staff tasks for the shift, working with support groups to ensure certain tasks can be completed, and being a source of communication between manufacturing staff and management.Perform vial thaw and scale up operations in a laminar air flow hood.Perform support activities for bioprocessing operations to produce clinical bulk material including but not limited to buffer and media preparation and filtration.Perform in-process testing using blood gas analyzers and pH, conductivity, and osmolalitymeters.Trained team members in media operations utilizing proper aseptic techniques in a safeand efficient manner.Operation and installation of Impulse media bags.Filtration operations with peristaltic pumps and pressurized tanks.Functional area support in clinical bulk and commercial processes.Clean and maintain equipment and workspaces around the plant.Assembly and operation of ATF units during cell culture operations.Daily sampling of cell culture from Single-Use Bioreactors as well as Stainless Steel Bioreactors on the manufacturing scale.

Thousand Oaks, Ca, Us

Perform vial thaw and scale up operations in a laminar air flow hood.Perform support activities for bioprocessing operations to produce clinical bulk material including but not limited to buffer and media preparation and filtration.Perform in-process testing using blood gas analyzers and pH, conductivity, and osmolalitymeters.Trained team members in media operations utilizing proper aseptic techniques in a safeand efficient manner.Operation and installation of Impulse media bags.Filtration operations with peristaltic pumps and pressurized tanks.Functional area support in clinical bulk and commercial processes.Clean and maintain equipment and workspaces around the plant.Assembly and operation of ATF units during cell culture operations.Daily sampling of cell culture from bioreactors.

Us

Perform support activities for bioprocessing operations to produce pre-clinical and phase appropriate clinical bulk material including but not limited to buffer and media preparation and filtration.Assisted with Downstream purification of harvested cell culture materials at pilot scale to producepre-clinical bulk material in a team-oriented setting.Some training on column packing, unpacking, and cleaning techniques for stainless steel andglass columns between 10 – 60cm diameters.Some training on various chromatography (Protein A, Cation Exchange (CEX), Anion Exchange(AEX), Hydrophobic Interaction (HIC), and Salt Tolerant Interaction (STIC)), Viral Filtration and UFDF operations at pilot scale using DeltaV automation control.Performed in-process testing using blood gas analyzers and pH, conductivity, and osmolalitymeters.Trained team members in media and buffer operations utilizing proper aseptic techniques in a safeand efficient manner.Coordinate endotoxin testing of formulation buffers between the Pilot Plant and the HighThroughput Analytical Laboratory.Operation and installation of Impulse media and harvest bags.Filtration operations with peristaltic pumps and pressurized tanks.Functional area support in GMP and Developmental processes.Clean and maintain equipment and workspaces around the plant.