Caroline Colasurdo

• Responsible for managing critical reagent and reference standard program, raw material, product testing (in-process and release) and stability program for commerical product manufacturing. • Direct Manager for Quality Control Analytical Sr Manager, Manager and Supervisor. • Oversight of method validation, transfer and analytical method life cycle management. • QC point of contact for multiple CMOs and CTLs to ensure timely release of product, escalations, review of external documents (deviations/LIRs, batch records, protocols, reports). • Responsible for laboratory operations processes, computerized systems, laboratory equipment, and software to comply with applicable quality systems and regulatory expectations. • Oversee stability program for multiple phases of manufactured products, interim and annual reports to support APR. • Business owner for equipment and software, implementation and validation of new laboratory instruments and software. • Deviation, CAPA, Change Control owner and training of QC analysts on QMS processes. • Close cross-functional collaboration to support timeline adherence with both internal and external manufacturing and testing facilities. • Responsible for the transfer of new or optimized existing assays in collaboration with Analytical Development. • Quality Control representative for regulatory inspections and third-party audits. • CMC Core team and Functional Leadership member to vet internal and external project projections and timelines (determining budget, resources, risk assessments and business plans).

●Directing organization of Quality Control scientists to ensure the highest level of quality and integrity for all Drug Substance, In-Process and Drug Product testing for allogeneic CAR-T therapies. ● Driving Phase I to Phase II submission support for allogeneic CAR-T therapies, bringing over 5 years of commercial Cell and Gene Therapy Autologous CAR-T quality control experience. ● Leading the Cell and Molecular Biology team through method validation, method verification and method transfer to our new state of the art manufacturing facility (www.cf1.com) with Quality Control laboratories for future in-house testing in a CGMP environment. ● Growing and leading a world class organization of scientists through active mentoring and sponsorship, increased visibility to non-routine testing activities and enhanced knowledge development ● Leading cross-functional teams across Quality Control, Raw Materials and Microbiology, including reagent and consumable management, and ensuring Health and Safety inspection completeness ● Owning and investigating deviation records, Change Controls, Out of Specification results and CAPA management, including cross-functional collaboration with QA and Manufacturing ● Driving Quality Control user requirements to support establishment of eQMS systems ● Advising teams for flow cytometry and cell based assays for investigations and to scale processes and procedures for high throughput manufacturing. ● Demonstrated SME status by authoring technical reports, protocols, SOPs, quantitative assay control performance trending and critical reagent qualifications, all compliant with FDA regulations.

-Responsible for QC project proposals, endorsements, project charter establishment, resource allocation, timeline preparation/adherence, business case establishments and financial approval. Work cross-functionally with OpEx and PMO to ensure successful delivery and launch of QC projects into laboratories. -Site Project Lead for QC data migration from paper-based to Electronic Laboratory Notebooks. Responsible for leading cross-functional team to plan and launch project from establishing system and assay specific URS through to validation, implementation and training. -Site Project Lead for first Novartis Cell and Gene Therapy QC Laboratory to receive global Lean Labs certification. Governance of team responsible for over 12 projects aimed at increasing QC efficiency and reduction of TpT while educating team in Lean and Six Sigma methodologies of process improvement. Annually recurring $1.27M savings for site through projects completed. -Site Project Lead for Novartis Global Lean Lab certification for QC Raw Materials and QC Microbiology laboratories including coaching of QC Analytics, QC Raw Materials and QC Microbiology analysts in Lean Six Sigma concepts for waste elimination and efficiency gains. Monitor processes and products to identify opportunities for continuous improvement. -Responsible for project timeline establishment and adherence, governance of deviation handling (QE, CAPA, RCA for laboratory investigations). -Quality SME responsible for laboratory tours and Requests for Information during internal and global RA audits. -Author of global methodology updates post-regulatory approval. Assurance of all methodology changes are harmonized across global platform for successful launch into multi-site QC laboratories. -Responsible for compilation or review of: site specific SOPs and forms used with QC labs, Annual Product Quality Report, Analytical Method Evaluation for transfer, Sampling Instructions, Justification of Specifications.

Quality Control, Bioanalytics Cell and Gene Therapy

Cell and Gene Therapy, Bioanalytics CAR-T o Honored and extremely dedicated QC analyst for the First-of-kind FDA approved CAR-T Therapy treatment of pediatric Acute Lymphoblastic Leukemia and Diffused Large B-Cell Lymphoma. o Maintaining the Novartis above-industry standard of data integrity, compliancy and GMP/GDP practices in quality control testing laboratories. o Responsible for QC testing of Raw Materials, In-Process Samples, Finished Product, Stability and site-specific protocols. o Aseptically prepare live cell samples for: cell thawing/washing, cryopreservation, qPCR analysis, and various qualitative analyses. o Responsible for quantitative sample analyses: Cell Count and Viability via Chemometec NucleoCounter NC-200 and phenotyping of cells by flow cytometry via Becton Dickinson Flow Cytometer. o Meticulous peer-review of Laboratory Data Sheets containing all original data for tests performed. o Operation of LIMS software for data entry, review and approval. o Additional responsibilities include the unique ability to assist in cross-functional department optimization to meet the demands of a rapid-growing quality department as well as assist in the continuous improvement of efficiency within the site. o Certified Novartis Trainer after completion of Novartis Global Train-The-Trainer program and qualification. o Responsible for new hire training and onboarding activities. o Revision of Standard Operating Procedures, Laboratory Data Sheets and Forms as necessary to update procedures.

o Composition of technical documents submitted for ANDA filings and responses to regulatory authorities. o Responsible for HPLC/UPLC method development, method remediation, method validation, formulation support of curing/compaction/coating studies and pilot/pivotal studies for Dissolution, Assay, Related Compounds, Blend Uniformity, Content Uniformity, KF moisture content and residual solvents testing. Solid oral dosage types include ER tablets, IR tablets, ER beads, ER pellets and capsules for generic controlled substances. o Current assignments include method development for assay and related compounds as well as discriminating dissolution method development. Additionally, QbD risk assessment experimentation and report of results for method development of assay and related compounds. o Composition of method development reports, pre-validation and validation protocols and reports, execution of formulation support sample testing, analysis and reporting of data in accordance with site specific SOPs. o Responsible for presentation of experimental design proposals to team for discussion, execution of experiments and reporting of data in technical reports. o Excellent ability to logically and systematically troubleshoot HPLC/UPLC/CG equipment as well as various equipment anomalies. o Compliance and knowledge of ICH and GMP/GLP regulatory requirements and site specific SOPs. o Performance of IQ/OP/PQ of GMP instruments previously used for R&D purposes only. o Calibration and preventative maintenance of laboratory instruments. o Responsible for receiving controlled substances into AR&D vault and dispensing of controlled substance samples to chemists for testing, all in accordance with DEA handling procedures and site specific SOPs. o Revision of departmental SOPs and writing new departmental SOPs when necessary.

• Responsibilities include method development and validation for transfer to QC laboratory. Developed methods for raw materials and generic injectable finished products manufactured in a GMP facility. • Assignments included HPLC/GC and wet chemistry testing and statistical trending of stability protocols, composition of method development reports and validation protocols. • Authoring technical documents used for ANDA filings; method development reports, method validation reports, deficiency notices. • Expert On-The-Job Certified Trainer of new employees in Knowledge and Skills assessments. • Demonstrated knowledge of product design, analytical research method development and statistical analysis of data generated. • Compliance and knowledge of GMP as well as regulatory requirements and site specific SOPs. • Responsible for development and execution of method validations, RRF determination protocols and validation protocols of forced degradation and API samples for assay and related substances. Previously completed assignments include development and validation of: range (accuracy, precision and linearity), specificity, repeatability, robustness, ruggedness, standard linearity, limit of quantitation determination, cross-over studies, solution stability determination and various product stability protocols. • Proven competence in execution of current Quality Control, USP, EP, and draft methods.

• Responsibilities include the routine testing of raw materials for use in the manufacture of injectable drugs in a cGMP facility. • Performance of wet chemistry and analytical chemistry techniques in accordance with USP and EP guidelines as well as any applicable site specific SOPs. • Responsible for reviewing the documentation of other chemists as well as approving tests performed in LIMS data entry system to ensure the timely release of products. • Responsible for plant wide collection and testing of incoming nitrogen samples, WFI for evaluation of TOC as well as daily calibrations of analytical balances, osmometers and conductivity meters.

Eleven years of veterinary technician and emergency technician experience. Responsible for performing necessary treatments on animals including; IV catheter placement, canine and feline phlebotomy, radiology, hematology, canine and feline vaccination, calculation of drug dosage, and multi-route injections. Responsible for assistance to veterinarian during surgical procedures both routine and emergency. Knowledge of surgical instruments and equipment. Uncommon ability to perform most complex veterinary technician assignments.