Crystal D'Silva

Associate Director - Material Characterization and Assessment @ Baxter International Inc.

About

Recognized subject matter expert for medical device safety. Frequently represents industry expertise in external fora. Experience in biological safety evaluation, management of global teams, and cross-functional/cross-cultural collaboration. Actively involved in standard development as a member of the ISO/TC 194 biological and clinical evaluation of medical devices technical committee. Avid yoga practitioner, salsa dancer/teacher, and trained in the North Indian classical dance kathak. Professional development enriched by artistic pursuits and vice versa. Passionate about science, education, and empowerment.

Country

Belgium

City

Brussels Metropolitan Area

Industry

Pharmaceuticals

Skill

Strategy, Communication, Team Leadership, Biocompatibility, in Vitro Toxicology, Teaching, Research and Development (R&D), Project Management, Regulatory Submissions, Regulatory Compliance, U.S. Title 21 CFR Part 11 Regulation, Good Laboratory Practice (GLP), ICH, Scientific Writing, U.S. Food and Drug Administration (FDA), Microsoft Office, Interpersonal Skills, Leadership, Critical Thinking, Creative Problem Solving

Experience

Associate Director - Material Characterization and Assessment

Baxter International Inc.

2024-6 - Present · 2 yrs 4 mos

Belgium

Deep domain expertise in Pre-Clinical Sciences (Toxicology/ Biocompatibility). External Engagement Strategy lead for Baxter's Infusion Therapies and Technology (ITT) R&D business segment. Responsible for establishing strategic Pre-Clinical R&D cross-region and cross-disciplinary programs/initiatives with global impact across Baxter Business Segments and Innovation platforms.

Senior Manager - Preclinical Toxicology

Baxter International Inc.

2023-7 - 2024-5 · 11 mos

Belgique

Research Scientist/Manager, Preclinical Toxicology

Baxter International Inc.

2022-5 - 2023-6 · 1 yr 2 mos

Belgium

Scientist responsible for biological risk assessment of medical devices, drug and combination products. Preclinical lead for the Acute Therapies Global Business Unit. Develop and lead preclinical regulatory submission content for global product submissions. Implement the use of ISO 10993-1, regional pharmacopeia, ICH, FDA, and 21 CFR Part 58 GLP guidelines. Manage on-site and remote direct reports, provide guidance for biological safety evaluation strategies, and review submission content.

Senior Research Associate

Baxter International Inc.

2020-4 - 2022-4 · 2 yrs 1 mo

Belgium

Biocompatibility subject matter expert (SME) and lead for Baxter's Acute Therapies product portfolio Develop biocompatibility testing strategies to support new product development and sustaining operations according to global and regional guidelines. Provide biological risk assessments for regulatory submissions in various regions and respond to regulators. Coordinate biological safety testing and act as Study Monitor for nonclinical safety and efficacy studies. Mentor junior team members, provide guidance for submission strategies, and review study documentation.

Research Associate III

Baxter International Inc.

2017-1 - 2020-3 · 3 yrs 3 mos

Belgium

Biocompatibility subject matter expert (SME). Coordinate biological safety testing and act as Study Monitor for nonclinical safety and efficacy studies. In-depth knowledge and understanding of ISO10993-1, regional pharmacopeia, International Conference of Harmonization (ICH), 21 CFR Part 58 Good Laboratory for Nonclinical Laboratory Studies (GLP), and other regulatory guidance based on region.