• Independently authored process related BLA sections S.2.2, S.2.4, S.2.5, S.2.6, 3.2.R, and S.6.• Coordinated control strategy alignment across disciplines for a mAb program. Identified gaps during process characterization and control strategy review, scheduled and lead discussions at multidisciplinary meetings for resolutions to enable robust regulatory filings.• Lead the development of process related IND section templates with multidisciplinary group. Supported the use of templates by first time authors for multiple programs by providing guidance during review meetings.

• Coordinated multidisciplinary teams to enable the writing of process validation protocols and reports to meet program timelines. Independently authored mAb cell culture, mAb purification, and ADC process validation protocols and reports.• Authored process related sections of investigational mAb INDs under highly accelerated timelines. Authored process related sections of other programs as required.• Supported the development of process validation protocol and report templates to standardize approaches across programs.

• Lead the upstream process development activities for 4 early stage programs for various modalities including ADC and fusion protein programs. Investigated media supplementation strategies to achieve target product quality profiles for hard to express proteins, including for glycosylation.• Lead a team including two full time contractors to complete laboratory work in support of process development. Oversaw weekend work scheduling for cell culture laboratories. • Investigated and applied new technologies to enable targeted glycosylation profiles including sugar nucleotide analysis, and qRT-PCR for gene expression analysis.• Participated in Glyco-analytical sub team across process development, protein analytics, and protein sciences groups.• Authored and reviewed technical reports, technical transfers, and other key documents including process related briefing book and IND sections for multiple programs.• Lead an interdisciplinary team to acquire and ensure appropriate validation of data acquisition software for cell culture analyzers to significantly enhance daily workflows.

• Lead the cell culture process development activities for clinical stage program. Lead the identification and mitigation of a glycosylation sensitivity in this molecule. Developed alternative media composition strategies.• Supported upstream process development activities for multiple early stage clinical programs.• Supported upstream process characterization activities for late stage clinical program.• Provided GMP manufacturing support by performing 3 L satellite cultures, providing daily project updates, and writing/reviewing design modifications, as well as campaign summary reports.• Performed process development related activities at 3 L bioreactor, AMBR250, and shake flask scales. Screened cell lines to enable MCB generation.• Provided technical transfer documentation, while interacting with members of manufacturing, planning, engineering, project management, and CMC to ensure project success.• Lead the evaluation and implementation of the Cedex Bio HT analyzer in Cell Culture to enhance upstream process understanding across all projects.

• Responsible for all Low Endotoxin Recovery (LER) studies. • Lead the development of updated / new methods to include LER validations for all current and future Phase III and Commercial projects.• Wrote and revised procedures as needed. • Interacted directly with clients to facilitate approvals of LER testing plans, meeting internal, external, and regulatory requirements.• Performed microbial identification assays by PCR.

• Performed routine microbiological testing.• Performed microbial IDs by PCR.• Performed bioburden and endotoxin test method validations.

• Performed routine microbiological testing procedures including bioburden, endotoxin, and contamination check testing. • Recorded data per cGMPs both on paper and using LIMS.