Dr. Jc Wung Email & Phone Number

Taiwan

Morrisville, Nc

● Contracted as Analytical Development Director at UPM Pharmaceutical and QC Director at Asymchem in 2018 and 2017 respectively.● Managed a team of 10-35 scientists, prioritize, plan work assignments, manage project timelines and prepare department budgets.● Directed analytical development, method validation, specification setting, QC release and stability studies for API and drug products (tablets, capsules, cream) monitored the stability trend, troubleshoot. ● Monitored the stability trend, troubleshoot, conducted OOS investigation, resolved OOS issues and implemented CAPA. ● Direct OOS investigations (stability, QC, and AD) for raw materials, in-process, and stability testing.● Review pre-approval submissions (ANDAs, DMFs) experience for clients including Amendments & Annual reports for small molecules.● Author and review CMC sections and provide strategy guidance for NDA and ANDA submissions.standard.

Corvallis, Oregon Area

• Serves as the key source for information on project timelines, budgets, status and interdependencies, communicating project team action items and critical decisions. • Develop, review and approve analytical method validation protocols, method transfer, reports, stability protocols, stability data, process validation protocol, specifications and test methods • Review raw data and report related to in-process, and product release, nonconformance investigations and qualification of process changes • Preparation of project team documentation including timeline, agendas, meeting minutes, status reports, project schedules and plans. • Work closely with project leaders/directors to develop comprehensive project plans and conduct effective project team meetings. • Tracking project tasks against the timeline, and preparing status reports. • Keep projects on time and on budget, function as a team problem solver, conflict resolution facilitator and meeting facilitator as necessary. • Acting as a liaison with external contractors (CRO and CMO) or partners. • Set-up and manage GMP/GLP analytical lab.• Lead the development of analytical procedures in support of pharmaceutical drug substance and product development projects • Ensure that analyses of experimental and stability samples are conducted strictly in accordance with cGMPs, company's SOPs and protocols• Convey results of analytical studies and participate in project discussions within development teams• Stay abreast of current trends in regulatory requirements in the field of CMC• Responsible for preparation and/or review of the CMC section of regulatory submission (INDs, NDAs)

Wilmington, Oh

• Performed method development for identification (ID) of raw materials using handheld Raman instrument (TruScan) and validated the method for ID purpose that saved company lots of time and money.• Conducted equivalency study for the PL-ELS1000 detector and Waters 2424 ELSD and demonstrated they are equivalent for molecular weight determinations.• Oversaw historical in-vitro data of products and use statistical software JMP to establish replicate range as acceptance criteria of the method.• Conducted dye ingress test as Container Closure Integrity (CCI) testing for prefilled syringes under different pressure conditions to evaluate impact of products during air shipment.• Oversaw stability program for injectable products and ensured it meets cGMP standard.

• Directed analytical method development, method validation, specification setting, stability studies and QC release for drug substances/products, troubleshoot, and resolved OOS issues.• Led and supervised an Analytical Team, and worked closely with internal and external collaborators and cross-functional teams to develop, optimize, and validate standardized analytical methods• Performed validation for Near-IR model to determine coating end point of the batches, improved 50% efficiency and accuracy for manufacturing process..• Developed a new analytical method for coated tablets, improved extraction efficiency, and save 50% efficiency while comparing to original method.• Oversaw the project activities, analytical documents (analytical methods, validation protocols, and reports) and stability study at CROs.

Ph.D., Analytical/Physical Chemistry

Master Of Science (Ms), Physical Chemistry

Activities and Societies: Phi lamda epsilon

Bachelor Of Science (Bs), Chemistry