Foram Rathi Email & Phone Number

California, United States

Carlsbad, California

• Lead and design analytical validation studies, also write test plans and reports for the studies.
• Work with multi-functional teams including software, regulatory, quality and attend core team meetings.
• Manage testing sites as a study lead to perform analytical verification and validation activities; includes resource and timeline management, training operators, shipping materials, monitoring study data and.
• Work with external sites/CRO to support the clinical trial study and other verification studies including external reproducibility study, orthogonal validation, participate in customer/ partner facing planning meetings.
• Facilitate Clinical Affairs team by assisting in site initiation visits, reviewing CRFs, clinical protocol and EDC database, maintaining study binder.
• Assist in preparing documentation for product launch, pre-submission, sPMA submission and FDA feedbacks.

Carlsbad, California

• Actively participated in different phases of clinical validation for the NGS-based IVD assay.
• Lead, design and execute verification and validation studies for the clinical validation of the NGS-based IVD assay including LoD study, guard banding study, interfering substances study, stability studies.
• Participated as an operator for clinical validation study.
• Worked with team to launch Oncomine Dx Target Test – first FDA approved NGS companion diagnostic.
• Performed detail-oriented experiments using Next-Generation sequencing, qPCR technologies and isolated nucleic acid from FFPE tumor samples.
• Analyzed data in Excel and Torrent Suite™ Software; presented results to the team at group meetings.

Greater San Diego Area

• Active participation in verification and validation (V&V) and developmental studies of the NGS-based IVD assay.
• Isolation of nucleic acid from FFPE tumor samples and performed quantitation using BioTek synergy II
• Construct libraries, templating with Ion OneTouch and sequencing using Ion Torrent PGM platform.
• Analyze sequencing data using Torrent Suite™ Software
• Troubleshoot experiments, identify and solve elementary problems in experimental designs.
• Maintain accurate lab notebook, thorough records of laboratory experiments and results with GDP

San Marcos

• Investigated the structure of proteins involved in curli formation in bacterium to understand Alzheimer’s disease.
• Performed cloning techniques and PCR for the protein expression, chromatography for protein purification, SDS-PAGE and different PCR methods for the identification of required proteins, and characterization by.

Bengaluru Area, India

• Evaluated the role of RNA binding proteins and post transcriptional modification in regeneration and homeostasis maintenance using Planarians as a model organism.
• Successful Knockdown was performed by feeding or injecting RNAi using micro-injections
• Characterization of genotype and phenotype was performed using different PCR methods including real-time qPCR and semi quantitative PCR approach, Probe preparation and In situ Hybridization, FISH, RNA isolation.

Bengaluru Area, India

- Introduction of targeting vectors in mouse ES cells via transfection and screening of the vector insertions by PCR and western blotting.- Assistance in the project for miRNA Locus study for gene that is highly expressed in embryonic stem cells in mouse using different PCR methods.- Primary knowledge of stem cell culture and transfection- Extensive work.

Bengaluru Area, India

• Vector construction for development of conditional knockout mice using basic molecular biology techniques to study important stages of the regeneration in muscles.: Hands-on experience with DNA-RNA work including.

Master’S Degree, Biotechnology, 3.96 Gpa

Activities and Societies: Winner of Al Kern Award for outstanding Semester-In-Resident project >1 project >15 courses

Master’S Degree, Biotechnology, 78%

Integrated Masters >1 project >20 courses