R&D professional with 10 years of very successful pharmaceutical industry experience in small molecule, biologics and pharmaceutics from early-phase development to commercialization.
Results-driven product stability senior manager/ expert with strong leadership experience.
In-depth knowledge of international regulations, cGMP's, GxP's, GCP's, ICH, FDA and EMEA regulations. Strong
experience in Regulatory CMC, drug and pharmaceutical development.
Management, statistical analysis, stability testing and Strong computer skills: Microsoft Office Suite
design, quality control laboratory testing, analytical method (Word, PowerPoint and Excel), Adobe Acrobat, Mac
equipment calibration and validation of systems and SLIM (Stability Laboratory Information Management
equipment's, team leadership. System), Publisher, Visio, Access, Adobe Acrobat,
GOLD, Crystal Reports, SAP/ R/3 system, SQL
Senior Manager01/2008 to CurrentPPD, R&D InterMune, IncSouth San Francisco, CA
Lead and managed the stability program for API and drug product for the US, EU, Canada and globally with external contract manufacturers for clinical and commercial product from early-phase development to commercialization.
Provided overall support for the stability studies with pirfenilogs, NCE's from the internal ITMN R&D group.
Monitored all ongoing stability studies associated with developmental, clinical, registration, process validation, commercial batches (post-approval commitments in bottle and blister configurations) globally.
Initiated new stability studies within ITMN and externally with CTL's and CMO's.
Provide analytical support for PPD, medicinal chemistry, drug development and discovery groups.
Review of analytical methods, validation methods and protocols, design stability studies.
Reviewed all product stability data and conducted trending to ensure it is within specification, deviations, out of specifications and CAPA's.
Created ITMN's stability program SOP and managed all revisions and trainings.
Managed vendor resupply of pirfenidone reference standards and impurity standard for external CMO's and CTL's.
Provided updated reference and impurity standard re-certified COAs to all vendors.
Authored, reviewed and approved stability protocols and stability reports, analytical test methods and reports, developmental protocols and reports.
Designed special studies and wrote reports for the following: temperature excursion, shipping, pallet, pack-integrity, bulk-hold time, bulk capsule stability, finished goods packaging, in-use and nano-encryption.
As a regulator contributor, compiled and reviewed all stability data for regulatory submissions, authored and reviewed drug product and drug substance sections for IND/NDA/NDS and MAA filings in the US, EU and Canada which led to approval of the MAA (March 3, 2011), NDS and NDA (October 15, 2014) for Esbriet for the treatment of Patients with IPF.
Conducted statistical analysis, trending and extrapolations of stability data for API/ DP and shelf-life extensions.
Successful completion of internal one-on-one audits of the stability program.
Participated in external audits with external agencies.
Provided ongoing support to the R&D group with the active role of a superuser/ administrator for eLINK.
Helped with the IQ, OQ and PQ validation of eLink.
Trained research to ensure that all of ITMN R&D and external collaborators for all CRO's and CMO's had completed their eLink training.
Quality Assurance Specialist II05/2007 to 01/2008Neurogesx, IncSan Mateo, CA
Perform document review of executed batch records, stability testing data and validation reports to support manufacture of commercial and clinical batches.
Perform first level QA document review of executed batch records, release and stability testing data, and any other contract manufacturer documentation to ensure compliance with regulations.
Manage the internal Neurogesx, Inc review and approval of contract manufacturer documentation, such as stability protocols and reports, master batch records, material specifications, test methods, validation protocols and reports, etc.
Interpret contractor documentation, provide expert advice and resolve issues in support of the company daily business activities, as it relates to regulator guidelines.
Represent the company's compliance standards in interactions with contract manufacturers Participate in person-in-plant activities, the review process of contractor documents in compliance with the company's internal procedures and participate in internal audits.
Manage on-going stability program for API and Drug Products.
Analytical Development, Stability/ Monitor Scientist I/II09/2006 to 05/2007InterMune, IncBrisbane, CA
Worked with regulatory, quality assurance and project teams to develop and maintain the stability program.
Statistically trended and monitored all stability data for product lots associated with Intermune.
Outstanding analytical skills to identify and resolve highly complex problems in situations where precedents may not be available, and to apply detailed regulations, standards, and policies, and procedures.
Managed and validated the stability chambers and freezers ensuring that the Installation Qualification and Operation Qualification of the equipment were complete.
Selected the stability software system for Intermune and wrote the stability software operating manual for SLIM Software System.
Project manager and lead for validation and installation of the stability laboratory information management system.
Coordinated all activities between QA, IT, vendor and contractors.
Wrote expiry reports for the protease inhibitor where data was analyzed to establish a retest date.
Demonstrated teamwork skills by bringing together QA, IT and vendors for installation of stability software.
Cooperative and collaborative work provided when working with project team members on the Pirfenidone and ITMN-191.
Demonstrated ability to work both independently and in a team-oriented environment, to follow through on assignments with minimal direction, and to independently prioritize work.
Prepared stability protocols, reports and amendments for all products.
Assumed responsibility for establishing the stability program in Intermune, demonstrating management of the software installation project and ongoing stability programs at Intermune.
Assumed all responsibility for stability chambers, including ongoing preventative maintenance and calibration, monitoring validation stability chambers to assure that all chambers are in compliance.
Developed a working knowledge of statistics and application of statistical techniques to analysis of stability data.
Provided a working knowledge or regulatory guidelines pertaining to stability (ICH guidelines) Developed and maintained the stability budget by creating and providing the stability matrix outlining all stability costs per study and time points for finance.
Strong background in statistics, familiarity with stability software and the ability to critically assess stability data and implement stability metrics'.
Strong organizational skills to coordinate stability programs across various projects.
Working knowledge and understanding of analytical methodology used to access stability of drug substance and drug product.
Proven organization and time-management skills to process a heavy workload, under tight deadlines and conflicting priorities, while maintaining constant attention to details.
Participated on and lead project teams requiring computer validation support as project manager.
Lead implementation of System Implementation Life Cycle (SILC) procedure quality management deliverables and project management methodology employed to deliver SILC Phases (Initiation, Planning, Execution, Monitoring & Controlling, Closing).
Lead computer validation projects with responsibility for budget, time and resources.
Developed, executed and leads computer validation activities in accordance with policies, standards and applicable regulatory expectations (i.e., 21 CFR 11, SOX).
Prepared, reviewed and approved SILC quality management deliverables, including but not limited to validation, plans, protocols, tests, and summary reports.
Conducted training on SLIM software system.
Quality Control, Stability Analyst II04/2005 to 09/2006VaxGen, IncSouth San Francisco, CA
Responsible for supporting all stability related activities which include protocol writing, pulling stability samples, transferring samples to QC lab or contractor for testing, testing of stability samples, stability date entry review and trending, and stability database management.
Optimize and troubleshoot assays in the laboratory.
Responsible for monitoring stability of BDS and drug products and informing of OOS or OOT stability issues to team(s).
Trend stability data and inform upper management of OOS/OOT test results.
Support analytical method transfer, QC SOP writing and training, and regulatory document controls.
Work with contract testing facilities and monitor their performance.
Revise, create and approve SOPs related to the stability program.
Manage the stability program for Bulk Drug Substance, Drug Product and Diluent.
Coordinate stability pulls, transfer to release in process stability group for testing, deliver and ship Drug Product, Bulk Drug Substance & Diluent to offsite contractors, and sending monthly pull schedule notifications to team.
Coordinate stability activities between Quality Assurance division, Manufacturing and outside companies.
Write stability protocols and initiate stability study for products.
Review and approve specification and quality control reports (stability).
Participate in internal, customer and FDA audits in regards to the stability program and write memos to satisfy CAPA items from audit observations.
Monitors validated stability chambers and assure that all chambers are in compliance with cGMP regulation.
Prepare reports and memos related to the stability program.
Perform investigation and write investigation and deviation reports for stability chamber excursions.
Review stability chamber qualification protocols and reports.
Create and maintain investigation, retain, report and stability database.
Perform monthly trend analysis on investigation reports, deviations and product rejects and prepare trend reports for senior management.
Perform special projects as assigned by senior management.
Provide training to new hires, sending notifications for training updates, update individual QC personnel training records (training matrix), and filing.
QA/QC liason for SOP training updates and notifications.
Updating training matrix for QC personnel and filing all records Provide support to ongoing qualitative investigation studies.
Coordinate and perfom appearance, pH and ELISA testing laboratory as needed.
Create and work closely with Regulatory on filings and submitting letters to the government.
BioPharma, QA Discrepancy Resolution Administrative Associate III/ QA Customer Complaints Associate II08/2004 to 03/2005Chiron CorporationEmeryville, CA
Under limited supervision, provided a variety of administrative functions in support of the Discrepancy Resolution group of BioPharma QA Commercial Product Release.
Continually met the business needs for QA by following the procedures governing Discrepancy Management and Corrective Actions Management.
Maintained complex DR filing systems, created files, audited and archived files.
Maintained existing databases, with an emphasis on support of Product Release through accurate and timely updates of DR information to GOLD (GMP On-Line Database) database.
Photocopied and collated sensitive GMP related documents.
Proof work and made corrections as necessary.
Performed administrative projects, including gathering information from various sources in support of DR/CAR evaluations.
Generated and presented metrics' to staff.
Ordered supplies, scheduled staff functions, staff meetings, MRB's, DR and CAR distribution, coping, scanning, filing, training binder maintenance.
Performed a combination of routine and non-routine tasks, which included the evaluation, and investigation of quality-related Betaseron/PFDS kit complaints for US and Non-US commercial products.
Received, evaluated, investigated and reported to any quality-related product complaints, medical complaints and inquiries in a timely manner.
Assisted in the investigation evaluation of Betaseron product complaints that may include: assessment of type of investigation required for a particular product; request of additional information; review of specific batch product records; recommendation of type of analysis performed on returned and retained samples; investigation of Betaseron and all marketed product complaints.
Analyzed data and evaluate information resulting from the findings of investigations, followed up and resolved all outstanding issues uncovered during the investigation process, generated an accurate report and ensure that files are completed and closed.
Generated trending reports and charts of all product complaints in a timely manner.
Assisted in the assessment of appropriate corrective actions if trends are observed, ensured that corrective actions are implemented.
Prepared reports perform audit of complaint files and trend tables in preparation for annual company internal audits and FDA inspections.
Research, trend data, and participated in investigations regarding internal studies as needed.
Maintained, update various complaint databases for completeness and ease of traceability and retrieval.
Assisted in the investigation of medical complaints received from Drug Safety.
Assisted in the withdrawal and/ or recall process of a product as necessary.
Wrote and revised SOP's for existing systems for consistency and compliance with regulatory requirements as needed.
Bachelor of Arts: Molecular and Cell Biology1 2004University of CaliforniaBerkeley, California, USAMolecular and Cell Biology