Florence Qie

• Work closely with Atea Analytical/CMC to support the development, manufacturing and testing of drug substance and drug product at CDMOs. Oversee external QC testing activities including in-process, release, stability and/or method validation. • Support/lead data integrity review and oversight of external lab’s data. Perform QC review of testing records for DS and DP GMP release and stability testing to verify the data generated at the CDMO laboratory are accurate, in compliance with cGMP regulations, meeting specifications and validated/approved analytical methods and procedures are followed. • Review batch release CoAs and stability reports generated by external QC/R&D labs to ensure accuracy and quality. Document batch analyses and stability testing results, COAs/reports in Atea quality system. • Compile batch histories and stability testing results to assist trend analysis. • Support product quality related investigations as well as analytical, QC lab OOS/OOT, deviations/investigations, identify proper CAPAs and monitor effectiveness checks. • Assist with method validation activities and work closely with analytical development to ensure new and existing analytical methodologies are appropriately written and or developed for use at CDMOs. • Tracking inventory of analytical reference standard materials, expiry date and standard qualification status. • Assist in QC review of regulatory submission documents and support regulatory filings.

• Monitored the quality control routine operations and stability studies in order to ensure timely completion of stability studies and smooth functioning of release activity • Reviewed IPC, Batch Release C of A, Stability protocol and report, Process Cleaning Report • Provided technical guidance related to trouble shooting in chromatography, experiment design etc. to minimize non-conformances • Evaluated root cause analysis in case of OOS, OOT, incidences and rejection and propose CAPAs • Communicated with Respective QC/QA heads for compliance and ensure timely closure of CAPAs on Trackwise system • Identified the training needs of employees based on the company SOP and pharmacopeial guidance • Monitored the training imparted on laboratory techniques, quality control procedures and principles of cGMP • Implemented 6S and kaizen in Quality Control lab and Quality Control team.

• Managed activities and personnel pertaining to Analytical Development in support of Product Development and Operations • Managed and/or co-coordinate analytical method development, validation and transfer, cleaning validation test methods • Coached and trained analysts and provide instrumental and analytical expertise • Assisted in development and revision of methods, specifications, and other documentation related to the analytical development and validation function • Ensured compliance to Health Canada, FDA regulatory requirements • Responsible for budgets, monitoring budgets and development work, resource and execution plan for all analytical and development projects, develop management process and tools, maintain monthly and quaterly status reports • Provided the facility CMC requirements for ANDA, NDA and IND submission

Conducted method transfer, verification & method validation on GC, HPLC in QC group Evaluated & Released QC samples (Pharmaceutical products, controlled substances, cosmetics, industry products) on time with good time management Trouble Shoot and solved all day-to-day process and technical problems regarding deviation, methods and instruments Conducted TAR and OOS investigation, and complete TAR and OOS reports Coordinated with QA and solved all technical issues in order to release projects in a timely manner Participated in creating and maintaining an atmosphere of team work throughout the laboratory Actively Involved in keeping working enviroment safe program as a safety community member

• Reviewed all analytical data generated by R&D and QC Department. • Issued operational deviations and corrective actions/Preventive Actions (CAPA’s) as applicable. • Ensured compliance with internal approved procedures, specifications and protocols of all generated data. • Reviewed out of specifications, analytical deviations, investigations and run log summaries as per SOP. • Performed initial QA review of research and pilot specifications versus raw data from method development, representative R&D samples and first batch introductions. • Maintained close communication with designated operation managers, clients with data concerns. • Revise via change control system data and system documentation as required according to internal SOPs. • Conducted GMP Quality training presentations bi monthly

• Participated in correspondence with suppliers and customers to address any issues related to raw material testing and releasing • Conducted full tests of organic synthesis in-process checks, raw materials, intermediates, final products and stability samples • Developed and validated innovative product analytical method

• Verified and approved hundreds of raw data generated by analytical laboratory, C of As, methods, method validation protocols and validation reports, in accordance with GMP standard • Provided quality assured method, validation report and other documents to Regulatory Affairs for FDA submission approval • Prepared and reviewed change controls, OOS, LIR reports with minimum supervision • Audited a pile of technical transfer protocols and technical transfer reports regarding changes to existing process and the impact to quality • Coordinated effective communication between QA and Chemists to solve the conflict

• Developed and validated HPLC, GC, TLC, IC and Dissolution analytical methods for generic drug substance and drug products in a timely manner • Participated in activities leading to product approval, i.e. deficiency letter responses for chemistry issues, investigations, with specific tasks outlined by manager • Organized group meeting to track the pace of project progress • Created the effective communication between chemists and reviewers to increase efficiencies, eliminate misunderstanding to facilitate the completion of a project • Transferred technologies from R&D lab to QC lab with the best quality • Tested and evaluated pharmaceutical active and inactive ingredients in support of specification development and NPD process • Conducted comparative studies for finished product to support formulation development • Conducted hundreds of C of A tests, Content Uniformity tests, Nasal Spray tests as per WI • Provided technical coaching to new chemists in the lab to follow SOPs • Assisted the analytical chemists with OOS investigation • Maintained and calibrated of analytical instruments