Manan D.
Analytical Project Leader @Thermo Fisher Scientific
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WORK HISTORY
Analytical Project Leader @Thermo Fisher Scientific
Mississauga, ON, CA
Project Management & Client Delivery: Lead routine client meetings to provide status updates, manage expectations, and drive project timelines to ensure On-Time Delivery (OTD) for all deliverables.Technical Documentation Lifecycle: Oversee the preparation, review, and approval of comprehensive technical documents, including Gap Analysis, Method Development/Validation protocols, and final stability reports.Client Technical Liaison: Serve as the central point of contact for technical inquiries, directly addressing client comments on reports and protocols to ensure alignment with specific requirements.Methodology Oversight: Manage documentation and workflows for Method Development (MD), Method Evaluation (ME), Method Validation (MV), and Method Transfer (MT), ensuring scientific integrity and regulatory compliance.Resource Coordination: Coordinate material readiness, including the procurement and management of standards, drug substances, and excipients, to facilitate seamless bench execution by the laboratory team.
EDUCATION
Delhi University
Bachelor of Pharmacy (B.Pharm.), Pharmaceutics
Brigham Young University
Master of Science (MS), Analytical Chemistry
RRC Polytech
Advanced Diploma, Quality Assurance and Quality Control in Pharmaceutical and Food
SKILLS
ABOUT MANAN D.
Experience in QA/QC and in operating various analytical instruments like Mass Spec and HPLCExperience in Statistical Data analysis using Excel and PythonProficient working in GMP and GDP environment with a thorough understanding of SOPsCompetent in analytical chemistry research and published findings in peer reviewed journalsEffectively managed teams for QA and QC processes by collaborating with different departments
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