Exton, Pennsylvania, United States
• Chemical Engineering with over fifteen years’ experience in pharmaceutical / biologic industries with extensive technical and compliance skills in areas of late stage process development, technology transfer, scale-up, validation, product launch and product life cycle of aseptic / sterile / solid-dose / suspension / Emulsion / lyophilization processes. • Designed and developed Pharmaceuticals / Biologic manufacturing processes of formulation, sterile filtration, filling, inspection and packaging; biologic processes such as fermentation, purification, conjugation. • Provided development of procedures/instructions of IOQs, PQ/PV, FRS, DDS, URS, P&IDs, C&Q, VPPs, FAT/SAT, FCCA, SLIA, Cleaning Validation, Sterilization and Utilities. • Strong knowledge of GMP/GLP (21 CFR Parts 11, 210 & 211, and 600 series), CBER, WHO, EP, EU and other regulation agencies. Strong leadership skills, project management and strategic planning skills. Strong interpersonal and negotiating skills.
• Provided quality lead/oversight of technology transfer and commercial manufacturing operations at external contract manufacture for formulation, filling, inspection, packaging and shipping sterile/solid-dose products including: API/Material qualification, equipment / process / system / cleaning validation, manufacturing and quality product release. • Generated, reviewed and approved all documentations related to technology transfer and commercial manufacturing operations such as protocols, reports, deviations, master validation plan, batch records, SOPs, CCs. Led key strategies for all qualification & validation projects under sterile/solid-dose form manufacturing processes. • Investigated process development / validation deviations occurred during tech transfer and commercial manufacturing batches. • Developed key quality systems include but not limited to annual product Reviews, supplier qualification, quality review board, quality agreement to assure site compliance with worldwide authorities. Supported FDA 483 / Warning Letter Remediation / Regulatory Inspection activities. • Provided QA oversight of pre-commercial manufacturing for ANDA and NDA submissions. Direct oversight of the following systems; analytical method review, technical transfers’ process, specification setting, quality testing standard. Reviewed and approved all GCP, GLP documents such as batch records, protocols, reports, change controls, SOP, procedures, design control systems. • Developed regulatory strategies to minimize compliance risks. Developed and maintained key quality metrics for the functional area to serve as a tool for continued improvement. • Provided primary FDA interface during inspections. Developed PAI readiness system for contractors and responded to audit observations to assure first time site approval for all ANDA/NDA applications (Worldwide). • Assured Corporate Management is informed of any potential compliance issue at the facilities.
• Managed technology transfer project activities for vaccines and buffers formulation and filling processes into state-of-the-art facilities. Responsibilities include; performing mixing studies, CIP and SIP cycles development, HMI recipes development, quality hold time studies for product in bag technology, prepare master validation plans, aseptic process simulations, and filterability studies. Wrote and executed development and process validation protocols and generated associated summary reports and data packs. Wrote and investigated deviations occurred and the CAPA systems. • Managed projects of manufacturing and shipping final bulk vaccines internationally. Generated separated set of documentations to support this project. • performed technical assessment of single use bag technology for final bulk vaccines. Developed methodology for stability program for disposable bag and carried out the studies. Supported disposable bag international shipping validation. • Led and managed the outsourcing projects for buffers and Media filled in disposable bag to support the new formulation and filling areas. • Designed and purchased single use components for formulation and filling processes, sterile filtration assembly, sampling devices, bag, colder, links, sterile quick connectors, Kleenpak Connectors (KPC). • Supported in design and execute filterability and filter optimization studies for vaccines processes. • Designed and developed Biologic manufacturing processes for formulation, sterile filtration, lyophilization, filing, inspection, packaging for aseptic products as well as up-stream and down-stream processes such as fermentation, purification, conjugation, . • Managed staffs for up-stream bulk vaccine manufacturing area. Responsibilities include managing production personnel, scheduling, daily operation needs, assist with deviation, troubleshooting, review and approve batch records.
• Managed contract manufacturing organizations of late-stage product development through commercialization manufacturing processes including, scale-up, product transfer, validation, product launch, and process improvements for solid (IR, ER), oral liquid, sterile, and patch products. • Served as a liaison between external contract manufacturers, internal quality groups, R&D, and regulatory groups to resolve technical issues; served as a project manager to coordinate activities in support projects of product development / validation, process improvement, tech transfer, and commercial products manufacturing. • Conducted technical assessments and cost effective analysis for changes to approved NDA and ANDA; Developed project scope, timeline, and cost estimations. Designed and managed studies for alternative API qualification for commercial products. • Reviewed and approved cGMP documents such as batch records, protocols, plant deviations, reports, SOPs, FDA submissions documents, and in preparing responses to FDA comments. • Developed business relation with multiple contract manufacturers where commercial and clinical products manufactured; Developed strong leadership skills, analytical thinking and problem solving capabilities as well as excellent organizational, interpersonal, multi tasking, project management, and strategic planning skills. Strong knowledge in cGMP, FDA guidelines, and DEA regulations. • Developed working knowledge of granulation, tabletting, and capsule technologies; knowledge of FDA SUPAC guidelines; • Developed strong interpersonal and negotiating skills to assure timelines are met. Reduced product costs by more than $1.5 million annually by selecting and changing component suppliers. • Provided technical support for product/process improvement.
• Managed the Technology Transfer team to develop analytical test methods, conduct product compatibility studies, scale-up manufacturing processes, and transfer new aseptic process such as; true solution, emulsion, and lyophilized products, to manufacture submission batches and product validation batches under cGMP compliance. • Designed and purchased pilot scale and commercial scale manufacturing equipment for sterile process, including emulsion and suspension products; acquired API, excipients, and packaging components used during process development and validation phases. • Assisted in hiring process by interviewing and qualifying candidates for the department. Trained new employees with the department procedures. Trained and directed entry level personnel. • Wrote and executed production validation batch records, protocols, and technical reports. Wrote and executed IQ/OQ/PQ packages for equipment for sterile processes. Wrote and executed cleaning validation protocols and issued corresponding technical reports.
Process development member of the Technology Transfer team to support process develop activities includes analytical methods development, conduct product compatibility studies, scale-up manufacturing processes, and transfer new aseptic process such as; true solution, emulsion, and lyophilized products, to manufacture submission batches and product validation batches under cGMP compliance. • Designed and purchased pilot scale and commercial scale manufacturing equipment for sterile process, including emulsion and suspension products; acquired API, excipients, and packaging components used during process development and validation phases. • Wrote and executed production validation batch records, protocols, and technical reports. Wrote and executed IQ/OQ/PQ packages for equipment for sterile processes. Wrote and executed cleaning validation protocols and issued corresponding technical reports.