Barry Pearson Email & Phone Number

Thousand Oaks, Ca, Us

Thousand Oaks, Ca, Us

Thousand Oaks, Ca, Us

Leading a team of talented Engineers and Scientists within the Drug Product Technologies (DPT) organization responsible for the development and deployment of digital technologies within the DPT organization and alignment with larger initiatives with Operations. This includes advancement of knowledge management platforms and novel application of Data Science principles. Holistic Lab Program Owner since February 2020, responsible for advancement of this digital platform. Owns long term strategic vision, definition of high level priorities, and focus on improving user experience. Global Process Owner for Amgen's Continued Process Verification (CPV) Quality Management System (QMS) from Q1 2018 to February 2020. The CPV QMS consists of Process and Product Monitoring systems along with manufacturing line monitoring or asset performance management.

Thousand Oaks, Ca, Us

Led various efforts to develop platform and capabilities within Drug Product Process Development to increase efficiency and standardize development packages across drug product portfolio. Point contact for Sterile Filtration Validation methodology across manufacturing network. Lead establishment of phase based validation approach captured in current Operating Standard and SOPs. Sending Site Lead for the technology transfer of all Amgen syringe filled drug products to a new syringe line at our Ireland facility. Managed a team accountable for all sending site deliverables.

Thousand Oaks, Ca, Us

Technology Transfer Core Team Leader for Xgeva, accountable for the successful transfer of commercial production of lead Amgen product to new facility in Ireland. FDA approval granted in Q2 2013. Technology Transfer Core Team Leader for Nplate, accountable for all deliverables and team management for transfer of production to Ireland facility. Drug Product Team Leader for Neulasta and Neupogen responsible for managing multiple activities related to the commercial production of products whose annual sales exceeded $4.5 billion. Drug Product Engineering Lead on Prolia launch team responsible for flawless launch of drug product in multiple jurisdictions. Required detailed knowledge of cross-functional operations and timely mitigation of several identified risks. Support included the implementation of an innovative demo device crucial to differentiation of product in a competitive field. Experience providing on-site process development support for commercial manufacturing facility. Responsible for the inception of a Strategic Resource Model business tool to effectively match available departmental resources with prioritized tasks. Led the creation of Drug Product Process Transfer Document improving on existing documentation package and providing a common document for tech transfers to both internal and external manufacturing sites. Technical Evaluator for denosumab. Responsible for providing technical leadership supporting process characterization, commercial production, regulatory filing and risk mitigation activities.

Thousand Oaks, Ca, Us

Drug Product Team Leader for a Phase 2 molecule, AMG 745. This role included the leadership of cross-functional team responsible for ensuring a successful manufacturing process for a high concentration lyophilized drug product. Leader for the successful Tech Transfer of SFP Enbrel drug product production to both internal and external commercial manufacturing sites. Technical Evaluator for SFP Enbrel. Responsible for design and execution of multiple studies characterizing drug product manufacturing processes for multiple formulation, fill and finish facilities. Supervised summer intern who customized capillary rheometer for the evaluation of shear stress on liquid protein formulations.

Thousand Oaks, Ca, Us

Utilized training gained at Biopharmaceutical Technology Transfer Training Course when serving at Technical Evaluator for Epogen SF. Key team member on Tech Transfer of drug product mfg process to AML. Led filter validation activities for new filter device. Served as the primary departmental representative on Global Operation Team simultaneously for 3 first in human drug products. Performed characterization of drug product manufacturing process for each molecule. Provided critical support of particle removal from drug product and supported investigation of particulate formation while serving as the Technical Evaluator for AMG 623. Designed and executed novel in-line drug product filtration system for use during IV push, IV infusion and subcutaneous injection to prevent delay to Phase II clinical program. This approach was presented at the 2006 ACS Prospectives Conference.

Thousand Oaks, Ca, Us

Project team leader for intra-site material transport process improvement project. Team established an efficient GMP compliant distribution system of clinical and commercial material at Thousand Oaks campus. Recommendation also provided $18K in annual cost savings compared to existing process. Presented poster at 2006 PD Symposia in AWA, “An Improved System for the Intra-site Material Transport of Bulk and Drug Product within Thousand Oaks.” Project team leader for multiple product wash-load cleaning cycle process improvement project. Implemented strategy and laid groundwork for a novel approach to cleaning systems for drug product manufacturing equipment. Identified potential cost savings of $350K per year for clinical fill facility. Drafted detailed experimental protocol for future investigation and successfully transferred project to future team leadership. Designed and led study to optimize mixing time for polysorbate solutions in clinical fill facility. Experimental data led to a 40% reduction in mixing time that increased operational efficiency while providing cost-savings of $12K/year at current operational capacity. Author of drug product sections and a key cross-functional reviewer for 3 IND filings. Including the first Amgen IND filing in CTD format providing a template for subsequent filings for other molecules.

Tarrytown, New York, Us

Integral member of team that developed marketable liquid and lyophilized formulations for several proteins while adhering to an aggressive timeline.Supervision of summer interns and mentorship of junior research associates.Extensive expertise operating, maintaining, repairing, and troubleshooting laboratory instrumentation and equipment. Analytical chemistry method development including RP-HPLC and 2D IEF.Member of team responsible for the successful implementation of Laboratory Information Management System into the preclinical program at Regeneron. Helped provide training of system and technical support to all members of Formulation Development Group.

Provided direct analytical support to entire process development team, including testing for both the efficiency and accuracy of several steps in a protein purification process and the involvement in crucial process change decisions.Independently developed quantitative assays for several proteins of interest using such techniques as western blotting and ELISA, leading to the quantification of several proteins in various purification stages as well in final product in a GMP environment.Gained hands on knowledge of such purification techniques as HPLC, protein extraction, anion and cation exchange column chromatography.Establishment and maintenance of process development database aiding in the tracking of related experiments for the entire group.

Ms, Neuroscience

Ba, Neuroscience