Winnie Chen, Phd, Cpgp Email & Phone Number

-Defined and implemented regulatory strategies for NDA, ANDA, IND and supplements.-Directed project teams as necessary based on scientific data, and changes in global regulatory environments-Anticipated risks and prepared for proper mitigation strategies for complex submissions-Proficient in scientific knowledge communication and guiding drug product development based on regulatory requirements-

• Translating business, user and regulatory requirements to product requirements• Developing the product verification strategies• Verifying and validating analytical methods for chemical products (drugs, medical devices and cosmetic)• Overseeing verification studies and reviewing results• Identifying and mitigating technical risks via DFMEA and other risk assessment approaches• Assisting and coordinating scale-up and manufacturing readiness for launch• Established appropriate quality plans that include all stages of the life cycle of the product.• Validated key design inputs including test method, usability, reliability, shelf life stability, performance, manufacturability, safety, serviceability, sustainability and effectiveness• Provided effective oversight of the execution of the Quality Plan, Verification and Validation, Risk Management activities, and of all design related activities during the product/system lifecycle• Supported regulatory submissions for Class III medical device and OTC drug Annual Report• Performed independent technical assessment on product quality performance and post-market product quality analysis to drive improvements. • Led quality related problem solving and root cause analysis during design and manufacturing• Performed gap analysis for Quality Management System to current guidance (ICH, FDA, IEC and ISO). • Managed and oversaw contracted vendors (research laboratories) for their deliverables• Produced and completed Quality Engineering Documents and chemistry system documents• Oversaw manufacturing processing using statistical process control method and Six Sigma principles

Bothell, Wa

-Cooperate closely with marketing, internal business groups, third party vendors and markets/sales organizations on Oral Healthcare projects-Lead the manufacturing scale-up for development batches, conduct technology transfer of new products into commercial manufacturing facilities and implement cleaning verfication/validation of process equipment needed to required cGMP and Health & Safety standards-Lead the manufacture of new products, at pilot scale to supply product for use in pivotal stability and commercial trails-Write and/or review/authorize GMP-critical documentation, such as reports, validation protocols, batch records, development and technology transfer reports-Develop processing equipment understanding/characterization at different scales to assist in development of scale-up models-Develop an understanding of how key quality attributes can be influenced by processing and therefore, be controlled

Exton, Pa

● Perform tasks to support pre-formulation, formulation development and pharmacy compounding studies for NCE and generic drug product with various dosage forms● Peform analytical testing to characterize drug substance and product● Evaluate product stability and write up specifications and assess product expiry● Evaluate primary and secondary packaging components● Execute studies to evaluate various process parameters for scale-up● Manufacture clinical batches and submission batches in GMP facilities● Develop study designs to sut each project requirement and interact with clients to resolve technical problems.● Support clients’ regulatory submissions (IND, NDA, and ANDA)

Schaumburg, Il

• ● Performed formulation and process development for sterile parenteral pharmaceuticals● Designed and optimized freeze-drying process for unstable drugs with unique crystalline and moisture requirements● Developed sterile parenteral products in various packaging materials ● Oversaw leachable/extractable studies and filter validation studies (bubble point, compatibility, bacterial retention and Vmax)● Optimized dissolution process for hydrophobic drug substances and developed their water-soluble injectable formulations● Maximized drug stability by investigating new excipients and drug-excipient interaction● Evaluated data and integrated it into formulation and process development● Transferred technology from lab scale to plant site for stability batch manufacturing, including writing batch records. ● Experienced in Fill-Finish operations for parenteral manufacturing.● Supervised stability (exhibit) batch manufacturing and authored CMC sections for ANDA/505b2 submission to FDA● Supported regulatory annual reportable, CBE and CBE-30 updates with solid technical justifications and evidence● Provided technical leadership and document review to contractors and outside labs as well as managed multiple projects

West Lafayette, In

• Actively involved in USDA-sponsored Biochip project• Initiated the application of microscale material in studying molecular interaction• Mathematically modeled convection-diffusion binary reaction in a novel microfluidic device• Optimized and characterized protein/enzyme patterning at interface• Assembled novel microfluidic immunoassays for fast screening biocatalysts• Invented an immobilized-antibody membrane filtration system for selective capture of pathogen• Analyzed and purified complex samples with membrane filtration, HPLC, ELISA and SDS-PAGE• Developed Cell Concentration and Recovery Kit (CCR) for rapid sample preparation for foodborne pathogen detection (US Patent 7,547,526 B2, 2009)• Supervised and trained summer students for their individual projects

Phd, Biomedical Engineering

Activities and Societies: • Simulated diffusion-controlled reaction in various shape of microfluidic channels • Assembled immobilized.

M.S, Biomedical Engineering

B. S, Chemical Engineering