Jaymi Fallon Email & Phone Number

Santa Monica, California, United States

Provide technical expertise and leadership to Product CMC/Quality Teams to develop, implement, and manage the strategies for Quality to meet late-stage and commercial product goals.

Newbury Park, Ca

Collaborated with company founder creating competitive bid proposal for pre-clinical topical formulation development stability studies ($30K). Provided mentorship, training, and “real world” hands on experience in a biotech company for local rising high school seniors.

Camarillo, Ca

• Lead, design and execute protein formulation and stability studies for international clients with molecules in early pre-clinical development.• Assay method development / method transfer for UHPLC / HPLC stability indicating assays (SE-HPLC, Ion-Exchange HPLC, & RP-HPLC).• Set up laboratory documentation and notebook practices.

Thousand Oaks, Ca

Pivotal Drug Product Development; Denosumab Formulation Technical Lead (FTL). Accountable for commercial formulation recommendation, drug product development strategy, risk mitigation plans, authoring INDa and US and global marketing applications for Prolia and XGEVA.● Led monoclonal antibody next generation drug product formulation development enabling funding, build, and launch of Amgen Singapore facility.● Built 4-person drug product development team and oversaw testing of Prolia and XGEVA. Determined instability based on data which led to revamping next generation IgG2 manufacturing process.● Partnered with cross functional team establishing drug product operations strategy. Reduced timelines by 30%.● Collaborated with Quality Control for stability strategy to support Biological License Application, drug product expiry, and clinical material expiry (label claims). Served as subject matter expert for Prolia, XGEVA, and Enbrel stability indicating analytical methods.● Served as subject matter expert for root cause analysis to evaluate out of trend results for in-process controls (IPC). Determined a specific raw material used in cell culture resulted in drug product out of trend IPC’s. Worked with site quality to tighten raw material incoming specifications.● Developed drug product formulation strategy for lifecycle management of IgG2, resulting in a new patent application.● Lab Manager responsible for troubleshooting instruments, inventory and ordering of laboratory consumables, and collaborating with external vendors for equipment repair, calibration, and annual preventive maintenance.

Raleigh-Durham, North Carolina Area

Scientist accountable for analytical method and protein formulation development. Partnered with small venture capital organizations along with large international pharmaceutical companies executing on agreed upon scope of contract deliverables.● Analytical method development (HPLC, SDS-PAGE, Western Blot, particle analysis, peptide mapping, protein characterization) supporting in-process upstream and downstream intermediates, along with final drug substance and drug product.● Method qualification and method transfer to Quality Control and/or contract testing laboratories (CTLs). ● QC Release and stability testing of drug substance and drug product.

Master Of Public Health (Mph), Management & Policy

Activities and Societies: Delta Omega Global Health Certificate

Bachelor Of Science - Bs, Biology

Activities and Societies: Chi Omega, College of Agriculture & Life Sciences Honors Program, Div. 1 Gymnast