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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• 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.