Danielle Brooks, MS, PMP

Leading in operational planning in regards to supply chain, budgets, and Practical Process Improvement (Operational Excellence) Responsible for coordination and execution of site administrative activities Apart of site leadership to help set goals for both the site and department

• Successfully ran a two-year laboratory expansion project that collaborated with multiple departments and vendors to expand on-site laboratory capabilities. Enabled Upstream, Downstream and Analytical operations to expand from a ~1,100 sq ft facility to a ~15,000 sq ft facility (November 2020-May 2022): o Lead in the identification, evaluation, and procurement of (~200 pieces) new equipment. Managed multi-state logistics to relocate equipment to and from offsite storage o Wrote equipment and process SOPs – routed through eDMS to ensure effective by go-live date o Ensured an inter-disciplinary laboratory layout and design that enables efficient process flow, and scale-up, while permitting room for future equipment and method improvements o Coordinated overall schedule to ensure on-target delivery for go-live date and project close-out while maintaining budget requirements • Responsible for day-to-day laboratory management: budgeting, resource planning, material shipments, and scheduling of operations, and equipment maintenance through design and implementation of SmartSheet tools and dashboards • Maintained and ensured a high-level of laboratory safety via stringent EHS and 5S compliance • Oversaw the laboratory continuous improvement programs as the departmental Practical Process Improvement Manager • Contributed to the team’s success as the departmental SAP subject matter expert, responsible for the tracking and procurement of all materials. Ensured appropriate stock levels • Managed 1 direct report and 2 indirect reports. Facilitated growth and development opportunities while providing guidance in establishing achievable goals. Provided direction for career growth through Thermo Fisher’s Performance Management Development process

• Acted as Downstream SME and Process Purification Lead, designing, executing, and troubleshooting experiments to develop novel manufacturing and analytical platforms and technologies for use in cell and viral vector manufacturing quick to clinic programs • Ensured experimental design would scale to meet large scale cGMP manufacturing needs, allowing future clients to accelerate early development timelines, mitigate risks, and assess future needs • Successfully lead presentations, technical discussions, and determinations of paths forward • Successfully trained new lab members on designing of experiments, purification techniques, equipment use, troubleshooting, safety, and technical writing • Supported lab coordinator by providing SAP expertise, process flow expertise, and generated equipment quality schedules • Cross trained and supported in the execution of suspension cell culturing, transfections, clarification of harvest material to provide support for execution to meet aggressive timelines

• Designed, implemented, and optimized downstream purification methods for purification of different viral vectors (AAV, Lentivirus, Adenovirus, and other natural and novel stereotypes) for multiple biopharmaceutical clients. Successfully served as a project lead to ensure successful scaling of operations and transfer to cGMP manufacturing • Developed custom dry weight and titrated buffer recipes to ensure consistent specification transfer to cGMP manufacturing, optimal chromatography elution steps, and product safety • Successfully trained PD and cGMP operators on purification techniques, equipment/software use and troubleshooting, safety considerations, and technical writing • Created development plans tailored to meet client work statements for specific product and CQAs • Effectively automated chromatography methods for DOE experiments • Produced and presented process development data and run reports, lead investigations, as well as lead trouble-shooting technical discussions with clients • Maintained and improved group documentation quality, safety, and delivery procedures to ensure right-first-time and on-time processes in order to improve team metrics • Drafted and reviewed process records, reports, manufacturing documents, and SOPs • Coordinated with Upstream Process Development, Assay Development, Facilities, sister cGMP departments, and Quality Assurance departments to ensure that materials, documents, and production timelines were on target and within budget • Executed client-led tech transfers and internal tech transfers • Coordinated with vendors and sales representatives to source materials and equipment, with the use of SAP and Product Specialists

• Designed, implemented, and optimized downstream purification methods for purification of different viral vectors (AAV, Lentivirus, Adenovirus, and other natural and novel stereotypes) for multiple biopharmaceutical clients. Successfully served as a project lead to ensure successful scaling of operations and transfer to cGMP manufacturing • Developed custom dry weight and titrated buffer recipes to ensure consistent specification transfer to cGMP manufacturing, optimal chromatography elution steps, and product safety • Successfully trained PD and cGMP operators on purification techniques, equipment/software use and troubleshooting, safety considerations, and technical writing • Created development plans tailored to meet client work statements for specific product and CQAs • Effectively automated chromatography methods for DOE experiments • Produced and presented process development data and run reports, lead investigations, as well as lead trouble-shooting technical discussions with clients • Maintained and improved group documentation quality, safety, and delivery procedures to ensure right-first-time and on-time processes in order to improve team metrics • Drafted and reviewed process records, reports, manufacturing documents, and SOPs • Coordinated with Upstream Process Development, Assay Development, Facilities, sister cGMP departments, and Quality Assurance departments to ensure that materials, documents, and production timelines were on target and within budget • Executed client-led tech transfers and internal tech transfers • Coordinated with vendors and sales representatives to source materials and equipment, with the use of SAP and Product Specialists

• Designed, implemented, and optimized downstream purification methods for purification of different viral vectors (AAV, Lentivirus, Adenovirus, and other natural and novel stereotypes) for multiple biopharmaceutical clients. Successfully served as a project lead to ensure successful scaling of operations and transfer to cGMP manufacturing • Developed custom dry weight and titrated buffer recipes to ensure consistent specification transfer to cGMP manufacturing, optimal chromatography elution steps, and product safety • Successfully trained PD and cGMP operators on purification techniques, equipment/software use and troubleshooting, safety considerations, and technical writing • Created development plans tailored to meet client work statements for specific product and CQAs • Effectively automated chromatography methods for DOE experiments • Produced and presented process development data and run reports, lead investigations, as well as lead trouble-shooting technical discussions with clients • Maintained and improved group documentation quality, safety, and delivery procedures to ensure right-first-time and on-time processes in order to improve team metrics • Drafted and reviewed process records, reports, manufacturing documents, and SOPs • Coordinated with Upstream Process Development, Assay Development, Facilities, sister cGMP departments, and Quality Assurance departments to ensure that materials, documents, and production timelines were on target and within budget • Executed client-led tech transfers and internal tech transfers • Coordinated with vendors and sales representatives to source materials and equipment, with the use of SAP and Product Specialists

• Performed independent experiments and supported the Downstream Process Development team • Maintained experimental procedures, results, and data according to good documentation procedures • Coordinated with vendors and sales representatives to source materials and equipment • Trained in various downstream purification and analytical techniques as well as SOPs, batch records, and manufacturing documents

• Performed independent experiments and supported the Downstream Process Development team • Maintained experimental procedures, results, and data according to good documentation procedures • Coordinated with vendors and sales representatives to source materials and equipment • Trained in various downstream purification and analytical techniques as well as SOPs, batch records, and manufacturing documents