Charles Murphy Email & Phone Number

Greater Los Angeles Area

Lead commercial product launch activities for bone health and oncology franchises and a mission-critical patient assistance conversion program for an established blockbuster drug in a dynamic environment. Managed vendors and alliance partners to ensure accountability and execution.• Establish and drive launch activities for the bone health franchise, including the rebranding of one blockbuster ($1B+ sales) and a complementary development therapy, enabling portfolio growth.• Drive deliverables for the technology arm of a patient assistance conversion program with over 130,000 patients resulting in increased patient retention and revenue growth in an agile environment. Developed a portfolio project management tool for managerial decision making.• Manage the execution of cross-functional project deliverables and tactics for product launch activities including commercial operations, market access, and human economics outcomes research.

Greater Los Angeles Area

Accountable for preparation, execution, and resolution of external inspections at a 1,300 employee, 24/7 manufacturing site. Managed a team of 3 direct reports and indirect operations peers. Assured conformance to regulations and corporate policies.• Managed external audits and inspections, including a zero-observation preapproval inspection. Received “Passion for Improving Lives” award.• Developed training program for inspection conduct for low production volume super-orphan product that enabled successful inspection.• Implemented inspection management process improvements, resulting in 40% reduction of support staff, 30% reduction in tasks, and 60% reduction in request transactions.• Led Inspection Readiness initiative by forging partnerships with key business units to enhance compliance state.

Thousand Oaks, Ca

Managed commercial and clinical stability teams with up to 10 direct reports. Accountable for determining stability strategy to meet global operations objectives. Created product-specific stability strategy, oversaw implementation, and approved regulatory submissions for direct reports for 5 commercial products in Colorado and 30+ clinical products in Thousand Oaks.• Directed stability testing programs for commercial and clinical biologics to ensure global operations, product quality, and regulatory requirements were met over intended product shelf life and lifecycle.• Achieved successful track record as functional area lead for global regulatory agency and business partner inspections / audits; remediated compliance concern with contract test lab.• Implemented continuous improvement methodologies, resulting in cost avoidances of over $3 million (received 2010 Excellence in Operations Award).• Developed forecasting and resource models for senior management, improving ability to properly allocate resources.• Coached, mentored, and motivated staff. Created, articulated, and reinforced department vision. Resolved conflicts and removed roadblocks to enable individual and team success.

Longmont, Co

Accountable for all Quality deliverables for successful product commercialization. Represented the Quality team on the cross-functional Global Operations Team.• Drove key Quality deliverables related to launching new Amgen product, resulting in first cycle approval. Key activities included regulatory submission authoring, site inspections / audits, drug product and drug substance technology transfers and comparability assessments (internal and with a contract manufacturer).• Identified improvement opportunities for product commercialization process, reducing complexity in comparator studies and regulatory submission process.• Authored regulatory submissions for product licensure in Japan and developed process for organization’s entry into emerging markets; approach currently still in use.• Reviewed and negotiated Supply and Quality Agreements with external partners as part of firm’s emerging market expansion strategy, meeting all timelines.

Thousand Oaks, Ca

Project Manager for QC technology transfer project. Owned unexpected lab result investigations to assess product impact and drive corrective / preventive actions.• Managed technology transfer project across four Amgen sites employing project management tools / training. Executed process improvements that reduced average flow time by 40% relative to previous efforts.• Authored regulatory filings and defended project strategies and deliverables during regulatory audit resulting in approval by all jurisdictions.• Initiated investigation on negative product quality trend, analyzed data, and escalated issue to senior management, resulting in lot rejection prior to patient distribution, preventing possible adverse events and costs of potential recall.• Applied statistical methods to oversee clinical and commercial laboratory method transfers between Process Development and Quality and between Quality sites, ensuring method was thoroughly evaluated for compliance in QC environment.

• Managed laboratory out-of-specification/unexpected result investigations to assess product impact and drive corrective/preventive actions.• Managed clinical and commercial laboratory method transfers/validations between Process Development-Analytical Sciences and Quality and between QAL sites.• Provided technical review of Analytical Method and Laboratory Procedure revisions.• Applied statistical methods to implement design of experiments to improve rational basis for technical problem solving.

Thousand Oaks, Ca

• Performed HPLC Analytical Methods in support of commercial and clinical drugs in a GMP/GLP regulated laboratory.• Conducted independent analytical method development projects.

• Developed a rapid microbiology test for the food industry.• Generated novel methods to manufacture reagents in house.• Managed the quality control program.