Quyen Schwing Email & Phone Number

Cherry Hill, Nj, Us

Wilmington, Delaware, Us

Responsibilities include gaining a deeper understanding of the function of polymeric products, development and evaluation of new functional excipients, project planning and execution, and customer support and training.• Lead and manage multiple projects, including polymer applications, innovation, de-formulation, and customer technical service projects.• Manage and direct team members to complete team projects according to timeline.• Support and demonstrate culture initiatives to ensure high performance and superior customer service by listening to team members’ feelings and ideas, and by helping new employees to overcome struggles with their projects.• Provide technical support, and work with new nutritional-oriented colleagues to support food team projects.• Present informational seminars to customers, and solicit questions and suggestions for new products.• Carry out experiments to address customer questions and concerns regarding products, and prepared detailed Technical Service Reports documenting findings and recommendations.• Devise tests to measure effectiveness of improved excipients, to guide synthesis efforts.• Assess performance of competitive products relative to Ashland materials, incorporating findings into improved sales tools.

Wilmington, Delaware, Us

Managed multiple projects, including customer technical service, polymer applications such as hot-melt extrusion, roller compaction, solvent spray drying, spheronization, tablet compression, wet granulation and film coating for modified release and solubilization technologies, and evaluated new excipients and technologies.• Project management duties included coordinating efforts of cross-functional team, and training scientists and technicians on necessary pharmaceutical and analytical technologies, and to assigning work schedules per project needs.• Technical presentations introduced clients and sales team to core concepts of solid dosage formulation, including development of oral matrix tablets, controlled-release technologies, hot melt extrusion, melt granulation extrusion and solid dispersion solvent spray drying.• Provided technical guidance to customers on new technology development, analytical assay development, formulation and process development and troubleshooting.• Authored product and quality documentation including: product specifications, stability protocols, batch records, study reports, standard operations procedure, and professional association posters.• Used statistical design of experiments; scaled up and scaled down experiments to characterize unit operation behavior, process robustness and control strategies for production of chemical compounds. Developed formulations and processes using Quality by Design approach required by the FDA.• Determined thermomechanical properties of new polymeric materials.

Developed generic semi-solid, medicated topical formulations of solutions, lotions, creams, and ointments. Determined quantitative compositions and sensory characteristics of Reference Listed Drugs, and prepared relevant documentation for ANDA submissions.• In preparation for formulation analysis, exhaustively reviewed relevant literature, including patent database, FDA and ICH guidelines, Orange Book, USP, and research articles.• Studied the function of surfactants, skin conditioners, thickening agents, preservatives, and pH adjustment ingredients, in order to correctly define order of addition in formulation process.• Determined complete quantitative composition of an RLD, using HPLC and GC, and defined final generic formulation for validation and exhibit batches under very compressed timelines. Provided technical input for troubleshooting internal exhibit batch issues.• Identified and obtained proper packaging materials and components, and performed packaging for lab-scale batches. Coordinated and oversaw manufacture of scaleup batches, including definition of critical process parameters, writing master batch records, and managing submission of products for necessary testing.• Monitored and interpreted short- and long-term stability testing under different conditions. Worked closely with analytical chemists, and submitted validation and stability samples for assay.• Reviewed process validation protocols and reports. Prepared master formula batch records, product development reports, and other documents for ANDA.

Dublin 2, Ie

Developed generic semi-solid, medicated topical formulations of solutions, lotions, creams, and ointments. Determined quantitative compositions and sensory characteristics of Reference Listed Drugs, and prepared relevant documentation for ANDA submissions.• In preparation for formulation analysis, exhaustively reviewed relevant literature, including patent database, FDA and ICH guidelines, Orange Book, USP, and research articles.• Studied the function of surfactants, skin conditioners, thickening agents, preservatives, and pH adjustment ingredients, in order to correctly define order of addition in formulation process.• Determined complete quantitative composition of an RLD, using HPLC and GC, and defined final generic formulation for validation and exhibit batches under very compressed timelines. Provided technical input for troubleshooting internal exhibit batch issues.• Identified and obtained proper packaging materials and components, and performed packaging for lab-scale batches. Coordinated and oversaw manufacture of scaleup batches, including definition of critical process parameters, writing master batch records, and managing submission of products for necessary testing.• Monitored and interpreted short- and long-term stability testing under different conditions. Worked closely with analytical chemists, and submitted validation and stability samples for assay.• Reviewed process validation protocols and reports. Prepared master formula batch records, product development reports, and other documents for ANDA.

Dublin 2, Ie

• Team member on formulation and process development of the current marketed product, TriCor® (fenofibrate), with responsibilities:o Led the development of fluid bed granulation processes; involved in various solids and analytical activities, such as blending, tableting, film coating, and characterization of intermediates and final products.o Wrote technology transfer documents to the Clinical Supplies Manufacturing and Process Development Engineering groups in a timely manner.o Prepared study reports to support the writing of relevant sections of the Pharmaceutics Development section of DMF and Master Development Report in support of client NDA.• Developed immediate-release tablet and capsule formulations incorporating NanoCrystal® technology for use in Phase I through Phase III studies.• Independently and skillfully operated solid dosage form processing equipment (Büchi spray dryer, fluid bed processor, tablet presses, tablet film coaters and immediate-release bead coater).• Implemented DOE full-factorial design studies to obtain the best media load and API concentration, to reduce residence time in a pilot scale milling process.• Wrote study reports detailing pharmaceutical development at laboratory and pilot scales in support of additional development studies for clients.

Dublin 2, Ie

• Developed a highly-redispersible spray-dried intermediate (SDI) of NanoCrystal®, suitable for stability evaluation, providing improved bioavailability. Developed fast-melting tablets with different flavors.• With team members, Process Engineering, and Clinical Supply Manufacturing groups, developed process parameters and executed Phase II demonstration batches, to meet an aggressive manufacturing timeline.• Participated in the technology transfer of laboratory- and pilot-scale formulations and processes to the Clinical Supplies Manufacturing group, and supported manufacture of bioavailability study GMP batches.

Us

• Isolated and identified the growth of pathogenic microorganisms. Performed antimicrobial susceptibility testing and planted all clinical specimens. Worked with primary cells and cell-line viral cultures and conducted a wide range of immunological and viral assays.• Worked with physicians, Infection Control, and staff to generate quantitative data analyses for clinical monitoring and documentation of antibiotics and microorganisms.• Trained Pathology and Infectious Disease residents and Medical Technology students in all phases of microbiology, immunology, parasitology, mycology, and virology.

Washington, Dc, Us

Used ELISA techniques and worked with automated Abbott and Ortho instruments to identify viruses. Observed cGMPs, and worked on a daily basis in all quality control testing functions.

Camden, Nj, Us

Performed electrophoresis for CKMB, hemoglobin, and proteins. Analyzed urine by characteristic morphology of all crystal formations and proteins. Performed routine hematology, urine analysis, and coagulation tests. Performed phlebotomy on patients.

M.S., Pharmaceutics

M.T., Medical Technology

B.S., Biology, Minor In Chemistry