Mausami Khimani Email & Phone Number

Canada

Canada

Canada

Ontario, Canada

- Provided expert guidance for different phases of analytical testing processes.- Collaborated with cross-functional teams to ensure alignment with project objectives and compliance standards.- Authored technical reports, protocols, and methods for Biopharma projects.

Mississauga, Ontario, Canada

- Directed Analytical Method Development and Validation projects, ensuring adherence to regulatory guidelines.- Managed resource allocation to meet project deadlines and synchronize with manufacturing schedule and project deliverables.- Facilitated seamless Technology Transfer processes for advanced analytical methods to enable efficient production scale-up.- Fostered strong relationships with clients, colleagues, and management to drive project success.- Managed outsourced testing and external lab vendors for Clients.- Oversaw and scheduled tasks for the team for accurate and timely completion and approval of records to facilitate test method transfer, qualification, and validation.- Led Continuous Improvement project for reagent and sample management using DMAIC methodology.- Authored equipment and associated software IQ/OQ/PQ protocols and reports.- Developed, approved, trained, and authored QC test methods.Accomplishments:- As a Senior Scientist, led the method development and validation of multiple Phase appropriate analytical methods for Clients within strict timelines and highly reproducible and accurate methods were developed and optimized. - Established processes and developed formats to optimize ELISA methods for next Clinical phase of Client products, which was immensely appreciated by Client.- Led the Operational Excellence project to streamline reagent receipt, storage and inventory tracking and maintenance of temperature sensitive lab reagents and samples using the DMAIC approach.- Recipient of the ICON Prize for Continuous Improvement: Awarded by National Resilience for ideas to instill the adoption of Continuous Improvement methodologies in processes and systems at Resilience.

Mississauga, Ontario, Canada

- Managed and coordinated multiple complex projects and programs in efficient, professional manner with multitasking and great attention to detail.- Scheduled and assigned work assignments of the team in LIMS.- Provided training and mentoring of new analysts to proficiency level and validate/check/audit their work.- Led method development, feasibility, validation and verification projects.- Interpretation of method development and validation data, generate product/ method statistics and provide evaluations.- Generated change controls.- Led and participated in technical discussions with SGS clients.- Prepared study protocols, reports, forms and SOPs.- Improved pre-existing analytical techniques, documentation and daily work duties and procedural or technical recommendations with firm understanding of regulatory framework.- Assisted in resolution of routine as well as non-routine technical problems, troubleshooting instrument malfunction or method execution problems, assisted other analysts with difficulties in testing.- Management of failure investigations and documentation and generate Deviations and CAPA.- Executed and performed routine and complex analytical testing, method development and analysis of biopharmaceutical finished products and raw materials.- Subject matter expert to answer technical queries as well as help analysts.- Performed equipment calibrations.

Mississauga, Ontario, Canada

- Executed and performed routine and complex analytical testing, method development and analysis of biopharmaceutical finished products and raw materials.- Subject matter expert to answer technical queries as well as help analysts.- Performed equipment calibrations.

Muscat Governorate, Oman

- Delivered unparalleled technical support, immersive training sessions, and captivating product demonstrations, driving sales growth for Molecular Biology, Genetics, Clinical Biochemistry equipment, Medical devices and consumables to existing or potential customers.- Forecast company's potential sales for Lab Department and ensure these targets are met.Achievements:• Proactively forecasted sales potential and surpassed designated targets through astute market analysis for Blood Vacutainers.• Established new business in Derma Biotech segment (PRP kit) with a shortened sales cycle and stable monthly earnings and direct distributorship for Randox Biosciences and Helena Biosciences.Product Training:• Product training of Helena Biosciences Coagulometer at Cytomed, UAE • Successfully completed training on Genetics & Molecular Biology equipments at Alliance Global Group, Dubai, UAE

Mumbai Area, India

- Method development for IEF for impurity profiling of recombinant protein on GE Multiphor Flat Bed gel electrophoresis.- Method validation: SDS-PAGE, IEX & SEC-HPLC - Perform batch testing analysis on Biopharmaceutical products.- Draft, review, update and approve Laboratory Quality systems, validation, test methods, specification and SOPs.- Review laboratory logbooks, notebooks and documentation.- Reviewing QC Documents that support analytical requirements in accordance with EU guidelines.- Generating method development reports, trend analysis reports and preparation of Standard Operating Protocols based on Method development.

Ahmedabad Area, India

- Method validation and development for Capillary Electrophoresis methods.- Perform analysis of Biopharmaceutical Drug substance, Drug Product, In-process and stability studies and reference standard samples. Generate trend analysis reports for Stability studies- As Project coordinator for a monoclonal antibody project, coordinate inter-department activities, ensuring production needs are effectively met and manage stability program according to ICH guidelines, ensuring completion of method transfer from R&D to QC- Maintenance of Reference standards using SAP and ultra-low deep freezers.- Draft, review, update Method Validation reports, SOPs, Test methods, Specifications, Stability Study protocol and reports- Review Laboratory logbooks, notebooks and Data recording sheets in accordance with ICH and EU guidelines- Investigate OOS occurrences and ensuring cGMP and GLP compliance in the laboratory

Master Of Science, Biotechnology, Summa Cum Laude (Distinction), First Class (Valedictorian)

Activities and Societies: Class Representative (2009)Received scholarship for being the Valedictorian in all 4 semesters

Bachelor Of Science, Biotechnology, Magna Cum Laude (Distinction, First Class)

Activities and Societies: Secretary of Science Association (2007)