Nirav D. Email & Phone Number

Canada

Providing consulting services to various WCT clients. Authoring various deliverables such as Initial Risk Assessment, Validation Plan, Requirements Specification (URS/FRS), Functional Risk Assessment, Design and Configuration Specification, Test Protocols (IQ/OQ/PQ/SIT/FAT/UAT), Release Plan, SOPs, Internal Audits, Periodic Reviews, Application Support Transition Plan, Deviation Summary Reports, Investigations & CAPA.

United States

• Designed and conducted mammalian cell culture experiments covering cell counting, seeding, cryopreservation and cell banking. Outlined a series of experiments from a scratch to characterize host cell bank to get optimum gDNA yield. • Executed qPCR and Octet operations in 96 well format to figure out consistency of the cell lines in terms of gene copy number and titer over extended generations. Carried out the quantification of IgG (titer measurement) by Pro A affinity chromatography using Agilent 1100 HPLC. • Assisted the group with the process of transcription-translation profiling of top candidates of various projects.• Performed maintenance and calibration of lab instruments like Thermo Nanodrop, Qiacube and 7500 RT PCR system using the certified kit and protocols from respective vendors.• Executed biorobot operations on regular basis for high throughput screening of the candidates. Analyzed multiple sequence alignments to identify sequence variants using ECS assay. Reported results and sequencing data interpretation to CLD group on weekly basis.

Ipswich, United States

RECONSTITUTION OF ARCHAEAL REPLISOME• Cloned 9N archaeal replisome genes into plasmid using Gibson cloning method, and effectively transformed plasmid to cloning and expression strains of E.coli to produce 9N archaeal protein. • Successfully cloned and expressed 9N Polymerase D, paper on identification and biochemical characterization of 9N PolymeraseD is to be published in a reputed Journal. • Utilized AKTA FPLC to purify proteins, and successfully developed/modified bioanalytical assays to demonstrate and characterize protein activity and interactions.• Effectively visualized DNA replication using 9N archaeal minimal replisome at the single molecular level using Zeiss Apotome microscope; results of the work are intended for publication in respected industry journal.

Boston,Ma

PERSISTER CELL STUDY IN E.COLI• Successfully applied theoretical concepts and literature searches into complex scientific research.• Worked diligently to expand knowledge and achieve short- and long-term project goals.

Supervised batch production of tablet dosage forms for flawless quality and consistency in cGMP regulated environment. Validated the pharmaceutical master formulary. Collaborated with several departments to quickly analyze and solve problems. Maintained batch manufacturing records and results.Key Contributions:• Optimized batch production using SOPs for speed, efficiency and accountability.• Performed calibration, preventive maintenance and trouble-shooting on Analytical Instruments under cGMP regulated environment.• Recognized for dedication, skill and commitment as the only undergraduate student working in this multifaceted, detail-oriented role.

Master'S Degree, Biotechnology

Bachelor Of Pharmacy (B.Pharm.), Pharmacy

Hsc