• Create and Maintain GMP Manufacturing Schedule o Facilitate inter-department communications to identify drug candidates and their implementation into the GMP process o Prioritize manufacturing campaigns, accounting for equipment and human resource limitations and setting realistic goals o Make go/no-go decisions on manufacturing timelines and prioritization with input from process leads o Update relevant departments on shifting timelines, including QA/C, AD/QC, Clinical Supplies, and HS&E o Determine scheduling impact of maintenance-related activities from Facilities and Operations teams • Oversee GMP Documentation o Ensure all necessary document and equipment change controls are implemented prior to manufacturing o Confirm completion of relevant investigations, deviations, and CAPAs prior to drug substance release o Ensure new chemistries are captured in appropriate SOPs and batch records, and CoAs and SDS documents are on file o Review Process Validation and Cleaning Validation protocols for GMP equipment and operations• GMP Manufacturing Supervisor o Provide specific goals and expectations for direct reports, meeting regularly to maintain clear understanding and focus o Identify employees’ skillsets and tailor their goals and expectations to best take advantage of their abilities o Set up required documentation and operational trainings for direct reports and monitor their progress o Establish open communication to provide opportunities for employees to convey their concerns, questions, and expectations

• Process Lead for GMP Oligonucleotide Synthesis Operations o Led operation of OligoProcess Synthesizer (up to 900 mmol scale), including column operations and solution preps o Trained new hires on solution prep, SOP/batch record documentation, synthesis method writing and execution, and equipment cleaning • Project Manager for Synthesis Scale-Up and Process Transfer Experiments o Identified amidite-drying properties and eliminated unnecessary process steps, decreasing prep times by 50% o Analyzed new solid support swelling properties, determining proper calculations for GMP synthesis column packing o Introduced pelletized sulfurizing reagent, decreasing prep time by 60% and decreasing operator chemical exposure o Implemented a safe and efficient drying procedure for activator solution, limiting water access to the process reaction

Operate AKTA 100 and OligoProcess oligonucleotide synthesizers.Assist in the large-scale synthesizing of oligonucleotides in a GMP environment.Operate AKTA Explorer, roto-evaporator, and lyophilizer for downstream oligonucleotide processing. Contribute to the optimization of large scale GMP synthesizing through small-scale process development

Led operation of OligoProcess Synthesizer responsible for large-scale GMP manufacturing of oligonucleotidesTrained employees on entire GMP synthesis process, including reagent preparation and equipment cleaning, along with use of Unicorn software for operating automated equipment. Initiated and reviewed SOPs and Batch Production Records for use in GMP process.Assumed lead role in managing experimental protocols and data in order to implement changes to the GMP process based on small-scale process development.Managed and monitored process inventory through SAP software.Assisted in downstream processing, including purification, ultra-filtration, conjugation, and annealing reactions.

Assisted in the GMP contract manufacturing of custom oligonucleotides, operating OP400 oligonucleotide synthesizer and AKTA 100 oligonucleotide synthesizer.

Operate AKTA 100 and OligoProcess oligonucleotide synthesizers.Assist in the large-scale synthesizing of oligonucleotides in a GMP environment.Executed Installation, Operation, and Performance Qualifications along with Process Validation and Cleaning Validation protocols for GMP equipment. Managed projects that identified properties of new solid support, sulfurizing reagent, and activator for transfer to GMP large-scale production. Initiated and reviewed SOPs in adherence to Good Manufacturing Practices.