research scientist
- Provide training on In-house SOPs/MSOPs/, amendment to SOPs/MSOPs, regulatory guidelines and relevant topics.
- Review of computerized system validation/ qualification records of software, electronic records and audit trail.
- Assist in the archival process & to ensure that the documents in the archive are properly managed properly & presented immediately.
- Training new QA auditors and verify the training files of employees.
- Review & verification of Qualification (IQ/OQ/PQ), calibration & validation records of equipment / instrument.
- Review and verify the User privileges of the software(s).
- Maintenance and update of approved supplier’s list.
research scientist
- Laid out nets and long lines for capturing animals to tag and release.
- Record data for species caught.
- Handled Lead roles in checking and conducting thorough internal audits, GLP/GCP & Gap analysis audits for compliance of GLP/GCP maintenance, QMS.
- Preparation and review of QA SOPs, General SOPs, MSOPs, manual, polices and their amendments.
research scientist, assistant intern at ornithology section
- Documented and reported test results after making graphical solutions and representations
- Evaluated test results for completeness and accuracy, submitting results to personnel and support treatments or diagnostics
- Recognized abnormal test results and devised corrective actions to retain accurate and valid results
- Performed including birds ringing procedures for testing or analysis on specimens and data sets
- Maintained confidentiality of all patient information to conform to HIPAA, internal and other regulatory standards
- Provided qualified input and development support for bird survey plans and study protocols carried out by researchers
- Performed in-depth interviews with research subjects and compiled data and analyses into reports for review by group leader
research scientist
- Responsible for developing and optimizing drug formulations for R&D pre-clinical trials and for commercial purposes (optimization of formulation processes at various scales)
- Perform research related to the development of lipid nanoparticle (LNP) formulations for nucleic acid delivery for in vivo and in vitro applications
- Analytical characterization of formulations and components using standard in-house assays and development of new assays or detailed investigations of specific LNP attributes as required
- Support accurate technology transfer to scientists in the scale-up department
- Support R&D activities related to novel drug delivery systems
- Compile and prepare technical and characterization reports for pre-clinical trials and for customers
- Maintenance database of past, present and future LNP physical characteristics and respective therapeutic index
research scientist
- Security Testing of DDoS Mitigation Solution and Web Application Firewall
- Performance Testing of Appliance based Solution
- Security Audit of Cloud-based WAF
- Create Signatures/Rules for WAF against known and upcoming attacks
- Create a Test Framework for automation of DDoS Solution Testing using Python
- Client Handling and Support
- Represent the products at Events and Conferences for insight on technical perspectives
research scientist (quality assurance & pharmacovigilance)
- Perform independent Audit of various activities of Bio-equivalence studies (clinical / Bio analytical studies) as per protocol/GCP/SOPs/MSOPs and applicable regulatory guidelines.
- Thorough knowledge in Checking of Clinical, Analytical R&D MD/ MV/Study raw data, log books, Chromatograms etc. generated during conduct of clinical studies as per GLP and GCP standards.
- Supervise/ participate in planning and conducting of internal project specific audit, system audit/process audit, Audit report and Audit certificate.
- Involved in Preparation, maintenance and archival of audit data as audit plan, audit report, audit response, audit checklists &QA Audit certificate.
- Manage support and oversee the clinical/Bio-analytical operation functions for development and implementation of polices and procedure.
- To perform In-process audit/ Retrospective audit of method validation/ addendum to method validation applicable reports and/ or amendment / erratum with in Pre-defined timelines.
- Fallow up and verification for the audit report response to ensure the Corrective/Preventive action are documented.
research scientist
- Process satellite images from different platforms for information extraction using image enhancements/corrections
- Develop and maintain geodatabase standards for multi-facet data fusion and processing
- Perform geospatial analysis, including spatial statistics for feature, variables and domain depiction.
- Design databases to support applications, ensuring system scalability, security, performance and reliability
- Design complex graphics, Tables and maps using independent judgment, creativity, and Mapping tools.
- Co-coordinating between different teams for effective GUI visualization by preparing design and functionality templates
- Investigate project requirements and enforcing new developments
research scientist
- Method development and validation of drug in biological matrix.
- Perform all the activities allotted by the group leader.
- All the activities performed with good documentation practice.
- Manage and update the site master file/Quality manual / Policies at due frequency.
research scientist
- Review all SAEs and Compensation related to SAEs that are notified during conduct of trial.
- Scheduling, planning and supporting in conducting internal/External, Vendor audits.
- Preparation of audit summary reports, categorization of findings and reporting of audit outcome reports with respective teams/departments for initiating, allocating, follow up of action points/CAPA plans/incidents till closure.
- Preparing gap assessments by reviewing operational department document ,regulatory guidelines, equipment’s, processes and methods in coordination with cross functional teams and effective implementation of CAPA, Change management etc.
research scientist
- Interacted with Scientists from SAMEER and DRDO to understand the requirements for designing front-end and back-end of the RADAR based application.
- Designed, developed and tested the desktop-based application using the PyQt designer library and a Relational database Postgresql.
- Participated in Peer Reviews of the Software.
- Captured time series continuous binary stream of data from the RADAR system through Serial Interfaces on a computer and converted into human-readable format using pyserial.
- Designed a data visualization dashboard using Matplotlib and Plotly.
- Worked on a Web-based dashboard design using Flask and ORM libraries like SQLAlchemy to store data into the Postgresql database.
- Worked in the development of the CI-CD pipeline using GIT, Jenkins, and Ansible.
research scientist
- Development and validation of bio analytical methods for NCE and generic molecules.
- Bio analysis of non-clinical study samples.
- Procurement and maintenance of records for Working standards, Reagents, Solvents and Lab consumables.
- Collate and review literature on recent trends and advances in Pharmacokinetics/ Toxicokinetics and bio analytical research.
- Ensure appropriate maintenance and calibration of allocated lab resources like mass spectrometers, pipettes, sample processing equipments, pH meter etc.
- Recording and verification of raw data.
- Reporting study plan/SOP (related to study) deviation to the study director.
research scientist
- Review and verification of Qualification / Validation / Calibration documents of instruments and software ( DPCM, SAS, Analyst , VLDB & Mass lynx etc.) used in clinical, Bio analytical & PKBS divisions.
- Monthly Report to management (RTM) for development of inspections , deficiencies & updates related to Quality System during conduct of study/system audit.
- Reviewing protocol, Clinical study report in compliance with relevant regulatory guidelines and Dossier’s (module 5) pertaining to various regulatory submission and e CTD document review for compliance.
- Handling of regulatory & Sponsor queries and timely closeouts by reviewing and supporting user departments.
research scientist
- Created a physical model to study cyanobacteria diffusion and growth. Presented my findings at the University of British Columbia physics conference.
- Designed and updated Python libraries to automate data collection and analysis.
- Wrote Unix scripts to automate data warehousing and increasing lab productivity by 10%.
- Created data visualizations that were included in two publications.
- Reported my findings from four of my projects to four different physics conferences.
- Designed SQL database to store and archive scientific data.
- Utilized R programming to create statistical models to calculate error and identify significant behaviour within scientific data.
senior research scientist (quality assurance & pharmacovigilance)
- Quality professional with experience in handling Quality management systems, QA documentations & Audits and Compliance.
- Proactively identify, support and/or lead the development, improvement and maintenance of the Quality System by identifying root causes and by addressing observed gaps in these process and systems.
- Inspection preparation, hosting, prepare/support of response and CAPA generation and monitoring of fallow up to ensure that observation as identified by inspectors is adequately addressed and implementation.
- Auditing quality system in clinical division, Bio analytical, PKBS & Pharmacovigilance through system, facility & process audits to confirm GCP, GVP compliance and other pertinent regulatory compliance.
- Responsible to develop Quality system for Risk Evaluation and Mitigation Strategies (REMS) at department.
- Involved in preparing and presenting Trend analysis to management half yearly.
- Involved in the preparation and review of SOP related to QA division and other department.
junior research scientist (adl r&d)
- Analytical Method development of male/ female hormones using HPLC.
- In process and reaction monitoring of hormones and reporting on basis of GLP.
- Complete analysis of stability samples .
- Wet lab: Handling Karlfiesher’s titration, IR, UV, SOR, Auto titrator.
- Force degradation, Optimization of hormones.
- Calibration of HPLC and other equipments.
research scientist
- Worked with Professor Jennie Rogers and other Ph.D. students on the research of data transfer between secure federated databases.
- Worked with a partner to present our research at a symposium at our high school after our internship ended.
- Encrypted data transmissions and secured data transfer to conceal confidential information from clients as it is were transmitted.
- Kept out tainted digital transfers.
research scientist
- Bio analysis of non-clinical and clinical study samples.
- Preparation and revision of SOP’s, Forms and Documents for GLP compliance.
- Recording and verification of raw data.
- Refer to reference materials, such as Google Scholar, NCBI, Scifinder, Discovery Studio to collate and review literature and conformations on recent trends and advances in Pharmacokinetics/ Toxicokinetics and bio analytical research.
junior research scientist
- Drug Discovery on Nipah Virus
- Identify ligands for molecular docking and machine learning
- Plan and supervise experiments related to carbon capture and storage.
- Conduct laboratory or field experiments with plants and soils.
research scientist
- Software development in C and Unix environment to simulate cyanobacteria growth
- Developed visual python script to visualize how cyanobacteria grow in certain conditions, which was used in presentations at physics conferences
- Developed Python code to analyze output from molecular dynamics simulations, output was quickly and easily parsed and plotted for publication
- Developed Python scripts to clean and explore data sets on luminosity data from the Herschel Space Telescope
- Expertly analyzed and visualized scientific data with visualization packages (bokeh, plotly, matplotlib)
research scientist
- Experimental research involving early stage drug discovery in HIV and cancer – strategically plan and execute methodology and experiments, troubleshooting and data analysis
- Commercial screening of compounds antiviral activity; Toxicity testing of compounds (HIV and cancer)
- Developing of biological assays (ELISAs, Luminescent, fluorescent, radioligands) for commercial use
- Write reports, manuscripts and formulate and deliver presentations on latest research findings for local and international conferences
- Transfer skills to students/interns
research scientist
- Preparing analytical laboratory documents like specification, methods, COAs, justification of specification, method validation protocol & reports, for ANDA submission using Adobe Acrobat by performing text-searchable scanning, bookmarking, hyperlinking and file naming in compliance to current eCTD requirements.
- Performing FDA deficiency letter interpretation and response, Equivalency study between USP compendial method and In-house method, mass balance, impurity calculation based on ICH guidance, etc.
- Performing pre-formulation study such as excipient compatibility, tablet scoring, force degradation study, etc.
- Conduct literature research for the method development of the new products.
- Performing calibration, maintenance and routine sample analysis of the laboratory equipment like pH meter, Spectro fluoro photometer, UV spectrophotometer, FTIR, Polarimeter, Refrectometer, Dissolution unit, Karl Fisher titration unit, HPLC, GC, Atomic Absorption spectrophotometer, Malvern Particle Size Analyzer.
- Performing routine testing, releasing of raw materials, blend testing, in-process material, finished products and stability testing.
- Train new chemists in instrumentation and analytical methods.
research scientist
- Perform the Genotoxicity study of the Pesticides in compliance with the international OECD guideline
- Key Research Development Centre, Crystal Crop Protection Ltd, Sonipat, Haryana-131028 India.Specify manipulative or computational methods to be applied to models.
- Define the standard operating procedures and the study plan for experiments.
- Train the test facility personnel to handle the experiments in accordance to the good laboratory practices.
- Gather the data and validate information, applying judgment and statistical tests.
- Collaborate with Test facility managers and decision makers to identify and solve a variety of problems and to clarify management objectives.
- Perform validation and testing of models to ensure adequacy and reformulate the study as necessary.
research scientist (computer vision & machine learning)
- Designed and developed AI features for ’IVision’ product to detect distress types like Pot Hole Detection, Cracks and transverse profiling of the pavement.
- Responsible for camera calibration and other sensors attached on specialised vehicles to collect pavement data.
- Collect and study blood samples and exosomes to determine the number of cells, their morphology, or their blood group, blood type, or compatibility for transfusion purposes, using microscopic techniques.
- Operate, calibrate, or maintain equipment used in quantitative or qualitative analysis, such as spectrophotometers, calorimeters, and PCR readers
research scientist
- Creation and verification of protocols and reports across numerous assays for execution by the operations team.
- Extensive use of software such as iSTATS,Probetrak, Testtrak and JMP for data analysis and graphical representation.
- Use of problem-solving and critical -thinking skills, as evidenced by the ability to organize experiments, analyze data, interpret results and draw conclusions.
- Responsible for characterization as well as execution of lab experiments in accordance with the scientific method and quality system.
- Awareness of FDA regulations and requirements for a new product development.
research scientist
- Led Coating Group
- Optimized mixing and coating conditions to improve coating uniformity and cell performance
- Led development of Dry Electrode, solvent free production
- Led development and testing of next generation cathode materials
- Assisted development of solid state electrolyte synthesis
- Planned projects, cell builds and testing
junior research scientist
- Analyzed and coded behavioral research data for current marital and teen dating studies
- Participated in weekly coding classes to further learn and enhance coding system
- Attended weekly reliability meetings to discuss coding discrepancies
- Created and presented research summaries relating to coding system or present studies
- Collaborated with mentor to build personal task and development portfolios
research scientist
- Planned, executed and analyzed primary research and literature search in developing a novel qRT-PCR based diagnostic test to determine the risk of recurrence in breast cancer patients
- Composed and delivered presentations for the laboratory and international conferences
- Communicated complex scientific ideas to physicians which helped in determining the need for our diagnostic test
- Trained and advised junior laboratory members