• Oversaw API development activities through product life cycles including process and analytical development, optimization, validation and characterization for CDMO and internal development projects.• Worked cross functionally with Business Commercial, Operation, Supply Chain, Quality Assurance, Quality Control, Validation, Regulatory and Engineering departments to ensure alignment with organization goals. • Possessed a strong understanding of pharmaceutical quality management systems, including Document Control, CAPA, Deviations, MasterControl electronic QMS, Environmental Monitoring, Change Control, Complaints, Calibration, Documentation, Training, Component Control, Batch Record Review, Label Control, and Product Release• Prepared, authored, and reviewed CMC sections (module 3) for IND/BLA submissions, securing all documentation met FDA guidelines and facilitated timely regulatory approvals.• Worked with the business commercial to understand its objectives and oversaw CDMO projects from initiation to completion, ensuring they were delivered on time, within scope, and within budget.• Strong knowledge of NMR, LC-MS/MS, HPLC, multi-angle light scattering, enzyme activity assays, and other general methods used for impurity profiling and product characterization of proteins, peptides, and short fragments of nucleic acids.• Reviewed technical documentation (protocols, reports) associated with manufacturing, site-to-site technology transfers, and PV, including reports for process/method development, stability studies, forced degradation, extractable and leachable, process/method validation, and cleaning validation.• Conducted and reviewed all process-related analytical data and. analyses for data-driven decision-making and supported data transfer and investigations.• Held regular meetings and led technical discussions with clients to provide updates on project status, ensuring alignment with client expectations.

• Led strategy development, implementation, and ongoing advancement of SPL’s new API products, CDMO products, and services. • Led regulatory submissions for ANDA applications, including authoring and reviewing regulatory briefing book to support successful submissions.• Oversaw innovation projects and provided scientific insight to ensure overall project continuity, direction, and success, from technology development through scale-up manufacturing, validation, and commercialization.• Led and supervised scientists in providing technical expertise and oversight for the implementation of innovative new product development projects at SPL, including project management in CMO selection, technology transfer and document review for oral solid drug product development.• Proficient in Microsoft Office tools, present project updates and new product development strategy to senior leaderships.• Researched NGS technology for potential use in the early detection of viral load in porcine tissues for various projects as part of viral control strategy.• Participated in internal audits, external customer/regulatory agency audits, and Pre-Approval Inspection (PAI) preparations.• Recruiting, training, developing and retaining staff for the process of department operations.• Managed capital expenditure and expense budget for department.

• Led analytical development for SPL new product development, implementation, and product characterization to support CDMO business at SPL• Managed projects involving sNDA approvals in a pharmaceutical setting, with a solid understanding of CMC strategies; authored and reviewed CMC-required reports and protocols.• Oversaw the new product process development and process scale-up to accommodate the commercial production• Worked cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Project Management, and Engineering departments to effectively transfer and maintain processes in the facility• Presented project updates to management team and contribute ideas to improve team processes• All responsibilities as Manager, R&D analytical

• Managed all R&D projects involved in analytics and supervised a team of research scientists and chemists• Provided technical guidance, including researching the subject, defining an experimental plan, preparing protocols, performing data analysis, interpretation of results and preparing reports• Responsible for method transfer, method development, and method validation for cGMP-compliant manufacturing• Participated in technical decisions affecting project issues. Identified problems, investigated alternatives and recommended possible courses of action. Worked with team members and others as appropriate to meet department and project objectives• Managed/participated in conference calls with customers • Reviewed reports/protocols related to method transfer, method development, and method validation for all R&D contract manufacturing projects• Reviewed and approved SOPs, CAPAs, deviations, LIRs, OOTs and Change Controls• Supervised personnel including interviewing, hiring, training, goal setting, performance evaluation, prioritization of work and compliance with safety policies

• Responsible for management of R & D analytical group to support testing of cGMP-compliant manufacturing products, methods include NMR, RP-HPLC, SAX-HPLC, Lowry assay, SEC/MALS, AGE, SDS-PAGE, Western blot, Bradford, enzyme activity, ELISA, TOC, Endotoxin LAL, etc.• Managed the analytical function in R & D to ensure prompt investigation and communications with customers• Oversaw daily operations in the laboratory to ensure cGMP compliance and adherence to ICH guidelines and project timelines• Reviewed and approved protocols, SOPs and reports, data interpretation and evaluation• Conducted out of specification/atypical result investigations (LIRs and ALIs), determine root cause and corrective and preventive actions and trending of all system suitability data

• Directed and performed method development, method qualification and method validation according to ICH guidelines for the PCR and SEC-MALS method.• Implemented species identification using PCR for heparin • Technical support to QA/QC in QPCR/PCR method development with a CMO

• Manufactured FP kits and reagents in standard sizes as 96-well and custom dispensing• Reviewed and revised manufacturing batch record procedures received from R & D• Developed protein purification protocols for pharmaceutical customers in contract service• Optimized the protein expression level under different growth conditions• Purified recombinant proteins expressed both in bacteria and insect cell• Performed kinase, phosphatase and ligand-receptor binding assays