Vanessa P.

Oncology Products/Programs | driving operational and strategic initiatives at BSB to advance TCR technology toward the clinic, directly contributing to company value creation. Proven expertise across the Clinical development, Discovery, Pre-clinical, and Clinical Development & Ops ; integrating scientific, strategic, and financial perspectives to optimize portfolio value, runaway, and execution in pre-revenue stage. Skilled at creating the critical intersection between drug development risks and value capture through rigorous assessment of technical viability, risks, economics, and strategic positioning. Extensive experience across pIND, IND, and Phase I trials in both US and ex-US. Demonstrated versatility across modalities, including TCR and BiTE platforms, combining scientific insight with sophisticated financial and strategic analysis to inform high-impact portfolio and business decisions. Landscape and market opportunity assessment by delivering eNPV and portfolio analysis for capital allocation.

Program Management covering CMC, clinical development, regulatory affairs, and non-clinical studies to launch US and ex-US cell & gene therapies. Oversight of vendors for scheduling, budget & and contract management. Solid experience with CMC & PD teams and external manufacturing for drug substances & drug products. GMP experience.

Sickle Cell | Sr Project Manager for CMC supporting cell therapy products (ATMP) in clinical and commercial readiness/stage - BLA readiness. Management of internal and external stakeholders, vendors in the scope of process and analytical development under GMP. Managed cross-functional teams, accountable for tech transfer across different plants, and knowledge and technology transfer across companies from PD supporting commercial department setup. Program: CTX-1001.

Oncology | CMC Project manager. Tech transfer for cell therapy products into the EU market with over 50 k hours of work for new products or process changes post approval aiming to increase capacity of manufacturing sites.

Tech transfer for cell and gene therapy for clinical trials (GMP), responsible for quality KPI management for the technology transfer department with close interaction with quality assurance. Supporting several projects from a technical end with impact assessment, implementation plan, and development of training curriculum for the SMEs of the department. Supporting track wise implementation and implementation of operational excellence tools for the department.

Dynamic and fast pace environment where I was able to bring my project management skills and expand my GMP knowledge. Trained on quality events (investigations, CAPA, and change request), risk assessment for the process in transference, and acted as a technical writer for the process that I was leading the transference by creating batch records. Technical Project Lead of technology transfer for cell and gene therapy products in the clinical phase stage internalizing the client's process at our site. Manage the creation of documentation such as BRM, material specification, URS, and SOP in pace with project timelines Support risk assessment during the TT to mitigate any risk to the product and project Responsible to start the TT and close by creating protocols and reports, and opening and close change requests Gained experience with CliniMACS prodigy and LOVO.

Project management for biopharmaceutical (biosimilar and originals) products at Bionovis site in partnership with Merck, Janssen, and BioManguinhos (Fiocruz) Tech transfer activities (analytical methodologies)for commercial products in GMP. Responsible for QC lab setup for the drug product testing, IPC testing, covering a variety of analytical and microbiological methods. Liaison between the company and international partners/suppliers being able to work with the cross-functional team: regulatory affairs, validation, engineering, operations located in several countries. Monoclonal antibody and recombinant proteins therapies for autoimmune diseases and relapsing forms of multiple sclerosis.

Founder and president of the Campinas #1 English Toastmasters Club, the very first club in Campinas. Our goal is for our members to build confidence and unleash their potential as leaders and communicators. Our achievements last year: - 80% satisfaction of our club members landing competitive jobs at consulting firms and trainee programs. - Directly Impacted 50 people, and delivered more than 100 hours in leadership and communication actions. - Created/ Supported a new Toastmasters clubs, which is impacting nearly 100 people locally -Selected distinguished club as actions oriented toward successful plan and administration - Supported the organization of the local events focused in leadership training for clubs in Sao Paulo state and open-house events Our club is the result of cross-country collaboration between Brazil and the US, where we receive support and mentoring from the MNRPCV club (USA). Brazilian Guide and ambassador of new educational programs for Toastmasters International - Pathways.

--Lead Innovation/Product development projects in an early phase of discovery in partnership with transfer technology offices (OTT/TTO). --Lead and management bacterial transporter team ( 5 direct reports) and special subprojects requiring multitasking and skillsets in microbiology, protein biochemistry, structure biology, cell biology and molecular biology. --Sought communicator presenting weekly updates and the advance of the project for stakeholders, symposiums, and conferences. --Raised 150K for the execution phase of the project.

-- International collaboration to accelerate our understanding of the phosphate system in prokaryotes in this hybrid project ( molecular biology and biochemistry). --Accelerate pipeline and project timeline achieving in 4 months the results expected for a year --Overseas project developed to increase the scientific and intellectual relations with external collaborator --Developed multicultural and linguistic sensibility to negotiate and manage short and high-performance projects -- Science skills improved at: X-ray crystallography, protein expression and purification, DNA analysis for recombinant protein production and engineering. Protein crystallization strategies.

--Research project using molecular biology to characterize at molecular level the biological role of scavenging systems in pathogenic bacteria --Summary of methodologies: circular dichroism, HPLC, protein electrophoresis, protein expression, X-ray crystallography, protein fluorescence. Molecular cloning and DNA analysis.

Strategy, Finance, Marketing, and electives at HKUST Business School. Healthcare Strategy & Leadership Certificate with a special focus on Biopharma Value Creation & Capturing, Venture Capital, and the Healthcare Ecosystem.

-Developed a strong expertise in the molecular biology applying methodologies as: molecular cloning, recombinant protein production using E. coli as a host system, protein purification using HPLC, structural biology, SDS-PAGE, Western Blot, polyclonal ab production, cell assays, protein characterization (CD, DLS, SAXS), strong DOE (design of experiment), and experience with several microorganisms cultivation, bioassays, and cell bank. - Unique project connecting biochemistry data with bacterial cell physiology through proteomics and metabolomics analysis to understand big picture of biological systems. - Lead and manage a cross-functional team (bioinformatic, system biology, plant specialist, clinicians, microbiologists), KOLs, and administrative staff. --Strong writing skill used to report progress of the project, achievements, or to request funding from agencies and sponsors

Science based coaching training focusing on personal and corporate needs.