• Independently manage all study complexity levels supporting the most complex studies and showing leadership throughout the year. • Support studies either alone or with a less experienced CSPM in US and/or in LU. • Show leadership through guiding those with less experience. • Set up and maintain studies through ownership, forecasting needs, understanding of IRT and TRACK. Initiate and approve label text. Provide input to the clinical protocol initial and amendments. • Demonstrate skill with trouble shooting problems in systems including IRT, TRACK, SSF/forecasting system. Identify and define process improvements or new processes needed to meet business needs. • Bring topics, updates and lessons learned to KMMs and CSPM Open Forum. Demonstrate leadership through active engagement, initiative, offering solutions and influencing department strategies. • Request ATEMS Parameters to be set up prior to 1st lot shipment from depot for applicable IRT studies. Collaborate with TE Team for studies with unique TE reporting requirements or as needed to address temperature excursion events. • Assist and request Training Manual updates following the request process. • Support Audits and Inspections. • Lead and represent CDSM on goals, initiatives, projects including local, cross-function and global. • Support the company and department culture by attending and participating in initiatives and in culture team meetings.

• Manage multiple trials of increasing complexity. This may include assisting other project managers by providing support on later phase and/or more complex clinical trials as needed. Provide instruction to less experienced project managers as needed.• Set up and maintenance responsibilities of trials as needed, including ownership, details and understanding of IRT. Troubleshoot IRT issues independently• Assist with Training Manual Reference Guide updates by identifying improvements and updates• Actively participate in department discussions as well as present topics. Share experience & knowledge with Colleagues & influence department strategies.• Support Audits and Inspections• Serve as the department Trial Master File SME(Subject Matter Expert) and L-PCYC IP Destruction SME and mentor to a new employee• Manage Third Party activities (eg. overencapsulation or packaging/labeling/distribution) on time and within budget, when applicable• Represent department on special projects, participate in cross-functional and/or global goals/projects, etc.• Support the company and department culture by supporting initiatives and participating in culture team meetings.• Collaborate with TE(Temperature Excursion) Manager or other team members to address temperature excursion events. • Review and assess temperature excursion events (at depot, clinical sites, during shipment transit) related to drug products and clinical supplies according to published analytical guidelines • Review IRT ATEMS notification and address damaged/quarantined/assigned unusable kits according to TE SOPs• Communicate final TE Assessment results to stakeholders and Clinical contacts• File TE Assessment documentations according to defined standard processes• Communicate TE Trends to appropriate stakeholders

• Supported the management of Trial Master File (TMF)• Collected and submitted required documents for clinical studies for TMF filing• Tracked review dates and ensured completion of studies• Maintained a proper archival and retention process of TMF artifacts• Performed temperature excursion evaluation, follow-ups and trending• Managed global clinical drug supply activities to ensure available drug supply for ongoing studies• Coordinated drug supply packaging and labeling activities with third party contractors• Managed clinical study label approval process • Monitored drug supply levels in IXRS(IRT) systems• Coordinated global clinical drug distribution to study sites and depots• Tracked reconciliation of product returns and destruction• Arranged and set-up meetings as needed• Ran scheduled reports from IRT and other inventory systems

• Participated in downstream main operations, under GMP conditions, using disposable equipment to deliver numerous bulk drug substances batches• Prepared cell culture media, buffers and solutions under GMP conditions to support drug substance manufacturing operation • Performed various research projects in order to improve established manufacturing procedures and to assist in the development of new production campaigns• Reviewed and revised standard operating procedure documents• Trained in deviation initiation and the implementation of corrective and preventative actions• Documented GMP operations in batch records per company policies and GDP Guidelines• Assisted GMP operations such as equipment setup, raw material logistics, equipment management• Participated in trainings to ensure that assigned tasks were executed in compliance with GMP and safety policies• Operated AktaReady systems, FlexAct sytems, filtration equipment, water systems, balances, autoclaves, tubing welders, tubing sealers, peristaltic pumps, laminar flow hoods, pH meters, conductivity meters and other laboratory equipment• Maintained accurate documentation including batch records, testing records, and equipment use records • Maintained chemical and lab supplies inventory and performed routine equipment maintenance and laboratory housekeeping

• Provided support and prepared data packets during FDA, EMA, internal, and client audits • Responsible for organization of drug product and drug substance stability data• Facilitated data and information exchanges with international branches of the company• Organized lot release data packets and created summary reports to ensure that drug lots were released for use in a timely manner • Coordinated with laboratory personnel and third party contract labs to ensure testing was completed on schedule• Validated and consolidated data within laboratory information management systems• Assisted with the labeling and preparation of various samples and equipment prior to shipping

• Sampled soil and collected various data from agricultural research plots throughout the Santa Cruz area• Processed soil samples and measured the electric conductivity and pH of the samples• Prepared various buffers and reference standards for lab operations• Measured nitrate and ammonium quantities through flow injection analysis of soil samples • Assisted in troubleshooting and repair of laboratory equipment

• Researched identifying characteristics of plants throughout the Santa Cruz area in order to distinguish between native and invasive species• Collected and propagated native seeds/seedlings to later be planted in the natural reserve site• Performed maintenance on existing restoration sites on the reserve• Repaired trails on the property and removed invasive species