Provide technical expertise in the areas of pharmaceutical analytical development, quality control, CMC strategy, stability programs and other applicable topics for biotech and small molecule API and products.

•Manage end to end External Quality Control activities for multiple Biological and mRNA based modalities
•Lead the stability program activities for GMP drug substances and drug products for GMP manufacturing, specification setting, IND enabling and long term stability programs, regulatory filings, change control and stability related QC investigations
•Responsible for oversight and management of CRO/CMO stability programs for commercial and clinical programs
•Liaise and work with Analytical Development and QC to monitor method performance
•Lead strategic initiation and establishment of data management systems for stability studies to enable phase appropriate regulatory submissions
•Provide technical review of analytical data integrity and laboratory documentation, method development reports and method validation protocols and reports
•Ensure compliance with cGMP in a manufacturing environment such that the products are assessed to approved specifications in a timely manner

•Responsible for all aspects of Quality Control operations at Audentes Therapeutics, Inc., including analytical testing operations, stability, microbiology testing, environmental monitoring, sample management and raw material management
•Lead Quality Control department in testing of gene therapy drug substances and drug products for clinical release, stability studies, and investigations according to manufacturing schedule and company development timelines
•Transfer and validation of analytical methods, review of protocols, reports, risk assessments and other documents to support QC operations
•Manage and expand QC resources, including personnel, equipment and laboratories, as required to support company operations
•Work with Manufacturing, Supply Chain, Quality Assurance and Regulatory departments to ensure efficient processes for lot release, regulatory submissions and commercial readiness
•Author and review CMC sections to support regulatory submissions

•Lead multi-functional teams for transfer of biological drug substance and drug product analytical methods to global Roche and external contract manufacturing sites; manage and drive drug substance, drug product and raw material analytical transfer activities, equipment acquisition and qualification, training activities, cleaning validation and preparation for stability studies, develop and manage Microsoft Project timeline documents to track transfer activities with respect to project timelines
•Represented Global Biologics QC on teams for selection of new contract manufacturing sites, including evaluation of GMP compliance, identification of potential risks and writing applicable sections of technical transfer master plan
•Wrote and review protocols, reports, risk assessments and other documents to support method transfer and write corresponding CMC sections for regulatory submissions
•Technical transfer leader to support transfer of drug product manufacturing

•Responsible for GMP Quality Control and Analytical Development function at Cytokinetics to support non-clinical development and GMP manufacturing of clinical supplies
•Participated on multi-functional team, working closely with Quality Assurance, Process Chemistry and Technical Operations in API and drug product development and GMP manufacturing with outside contractors to provide supplies for clinical studies
•Managed outsourced technical transfer, method validation, release testing, investigations and stability programs for all API and dosage forms and reference standards in the clinic and in development
•Drafted, reviewed and justified manufacturing batch records, specifications, sampling plans, validation protocols, stability protocols, test methods, deviations, investigations and Quality SOPs
•Wrote CMC quality and characterization sections and technical reports to support development programs and regulatory submissions
•Lead in-house analytical development

•Staffed and managed Analytical Development group of six scientists and research associates to develop and validate methods, design and conduct product development studies, support GLP studies, lead investigations and troubleshoot analytical and formulation issues for drug-eluting stent system platform
•Wrote and reviewed documentation to support PMA regulatory filing (research and validation reports, CMC/CTD sections, product and excipient control)

•Staffed and managed Analytical Development group of ten scientists and research associates and managed GMP laboratory for physical and chemical characterization, analytical development and method validation for multiple APIs and drug products
•Contributed to CMC/CTD for multiple NDAs and INDs (API physicochemical characterization, product characterization, test methods, specifications and justification, batch analysis, formulation development)
•Provided analytical expertise and direction on multi-functional product development teams
•Provided physicochemical analytical support for chemical development, process chemistry, pharmaceutical development, and commercial manufacturing
•Wrote and reviewed technical reports, protocols, test methods, SOPs, and specifications