Xiaohan(April) Peng Email & Phone Number

Cambridge, Massachusetts, Us

Cambridge, Massachusetts, Us

Lead design, execution, documentation, and presentation of relevant experimentation to support Drug Product teams in advancing formulation development, fill/finish process development, container development, process characterization, technology transfer, and regulatory authoring of our mRNA portfolio candidates.Design and execute detailed experiments using risk assessments, appropriate scale down models, QbD principles, and process characterization/modeling techniques to develop and troubleshoot specific unit operations.Author and review technical protocols, reports, product impact assessments, and regulatory sections as required in support of IND and marketing application submissionsEnable development of container closure options for Moderna clinical and commercial products by establishing test protocols and procedures as well as partnerships with external partners as required.Participate in Drug Product teams responsible for Drug Product formulation and process development for pipeline and lifecycle management projectsLead multiple activities in parallel to drive projects to completion, meeting timelines and key deliverables Support authoring and review of regulatory submissions

Cambridge, Massachusetts, Us

Design, execute, and document studies to characterize and/or scale-up various fill/finish unit operations (freeze/thaw, mixing, filtration, filling, visual inspection, etc.)Develop approaches and execute studies to evaluate the compatibility of Drug Product with processing materials, container closure components, and sterilization processes.Participate in Drug Product teams responsible for Drug Product formulation and process development for pipeline and lifecycle management projectsMaintain meticulous records through ELN and report authoring to ensure documentation compliance in support of cGMP activitiesLead multiple activities in parallel to drive projects to completion, meeting timelines and key deliverables Support authoring and review of regulatory submissions

Melbourne, Victoria, Au

Performing and developing lyophilization experiments for protein, nucleic acid and liposomal formulations;Performing bench-top particles formulation using various filtration, TFF, centrifugation and chromatographic techniques to support preclinical studies;Conducting LNP characterizations: particle size(DLS), encapsulation, payload quantification (UPLC), and lipid recovery analysis (UPLC), osmolality (osmometer);Conducting assays and troubleshooting assay development for formulated materials;Designing, executing, analyzing, and reporting data from experiments in a timely manner;Maintaining the required documentation, eg: experimental reports, SOPs, batch records;Preparing and presenting data in the context of the overall project at cross-functional meetings.

Boston, Ma, Us

work under supervision of post-doc. • mammalian cell maintenance, cancer resistance related research.• rt-PCR, nanoemulsion formulation, protein purification and analyzation by western blot, HPLC, particles characterization, cell image.• Maintained a laboratory notebook

Cambridge, Cambridgeshire, Gb

Worked as sales intern in respiratory group.Kept connection with doctors in hospital.Gave patients guidance of inhaler of Symbicort Turbuhale. Collected feedback message from patients about COPD, asthma and usage of Symbicort Turbuhale by using Excel.

Followed protocol to test supplements to determine safety and quality control. Learned importance of precision during experiments and utilized lab skills learned in class

Montreal, Quebec, Ca

Education record

Bachelor’S Degree, Pharmacy