Bima Rai
Fort Worth,USA
Summary
Highly skilled Scientist with proven expertise in bioinformatics, genetic engineering, and project management. Demonstrated success in leading complex research projects at Abbott Laboratories, optimizing protocols, and collaborating across teams to drive scientific innovation. Adept at leveraging extensive laboratory experience to develop new methods and technologies, aiming to lead projects that push the boundaries of scientific discovery.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Scientist I
Abbott Laboratories
Irving, USA
06.2021 - Current
- Developed new methods and technologies to advance projects, requiring minimal oversight.
- Executes experiments, accomplishes established milestones, and summarizes data, interprets results.
- Led team efforts in planning and executing project plans, achieving key milestones within set timelines.
- Participates in project planning for moderately complex projects with oversight from leaders; Participates in defining project goals; develops simple timelines; begins to comprehend resource requirements.
- Documents experimental results and procedures independently, including verification and validation reports according to established guidelines
- Perform risk assessment and identifying control measure for the risk; Identify new risk and update the Risk Management Plan
- Responsible for implementing and maintaining the effectiveness of the quality system
- Conducts moderately complex experiments and recommends options for other project approaches or experiments
- Possesses and applies knowledge of principles, practices and procedures and can drive projects to completion with minimal oversight
- Responsible for implementing and maintaining the effectiveness of the quality system
- Presents technical findings to both internal and external stakeholders, enhancing project communication.
Surgical IOL Lead
Alcon Laboratories
Fort Worth, USA
03.2018 - 06.2021
- Conduct mechanical, material, and optical testing related to IOL devices in support of project activities in product design, technology development and product registration, and document the data into technical reports
- Worked as a System Pro to perform qualification and validation activities IQ, OQ, PQ (Installation Qualification, Operational Qualification, and Performance Qualification) for IOL equipment
- Applied Statistical Analysis, and six-sigma tool like 5 Whys, 5S, and capability analysis, Gage R&R etc
- To solve engineering problems and improve process
- Led process optimization and yield improvement activities for IOL products to meet R&D production deliverables
- Supervised and trained new PILOT line and SAM line technicians to meet company’s standard
- Worked as Environmental Monitoring Qualification SME for new Pilot Line and SAM Line
- Authored and updated work instruction, validation protocols and report used for new and existing products
- Supported Tech Transfer Engineering Group to validate the equipment, commission new equipment and facilities
- Authored User requirement specification, functional requirement specification for computer system validation (CSV) in accordance with FDA regulation including 21 CFR part 11
- Worked with Project Managers to develop functional strategies to support the attainment of program milestones
- Built and kept sturdy lab based IOL Pilot Line capability for process and prototyping by supporting the validation and commission of ISO class 7 Cleanrooms
- Supported the development of semi-automated processes and equipment for production of next generation IOL optical, material, and mechanical platforms for clinical production
- Collaborated effectively at all levels within Quality as well as cross functionally with departments such as Manufacturing, R&D, and Tech Transfer
- Supported internal audit to assure alignment to corporate policies, internal standards/requirements, and compliance with regulatory requirement
- Strong knowledge of FDA 21 CFR Part 820 and ISO 13485 and strongly communicated, team worked, problem solving, decision- making, and root cause analysis skill
- Provided technical report to process development engineers to support the development of new processes and platforms
Surgical IOL Principal Tech
Alcon Laboratories
Fort Worth, USA
12.2015 - 03.2018
- Collaborated with different functions to coordinate and schedule project deliverables and timelines
- Provided technical assistant to process development engineers to support the development of new processes and platforms
- Worked into R&D Pilot Line manufacturing intraocular lenses (IOL)
- Clean Room Laboratory experience
- Trained on Final Dimension Measurement (FDM) and Pouch Sealing, Plasma, Nimo, Pro-2, Vacuum dry and all the small processes in the clean room
- GMP & GDP in an FDA regulated Pharmaceutical and Medical Device environment
- Collected historical process parameters to enable better understanding of the process, quality, and manufacturing protocols, and enact experiments to pinpoint issues that arise in the development process
- Worked in major projects like Enable, Clarion, Acryosof, EDF, and Achromatizing
- Also, worked on Clinical lots for Clarion EDF
- Support Semi Automated Machine line for Inspection Unit
- Had always collaborate and communicated with colleagues within the function and assisted the co-workers
- Worked with various technical sub teams on development of new IOL manufacturing processes
- Also, lead associates in testing mechanical design specifications of intraocular lenses during the prototyping and development stages of new products
Quality Assurance
Johnson & Johnson
Irving, USA
11.2014 - 03.2015
- Hands-on experience in Incoming materials inspections, finished device and packaging QA inspection and testing
- General Services Laboratory (GSLInstron 5960 pull test, Gel Cohesion Testing, TA.XTPlus texture analyzer, FTIR etc.)
- Rubber tensile standards, such as ASTM D412 and ISO 37
- ASTM/ASQ, MIL Std, and C=Zero acceptance sampling plans
- Silicone Gel Cohesion testing
- Drop Gage and Caliper measuring
- GSL supporting production in QA Process monitor & Finished device monitor testing, chemical testing and curing
- Interpret blueprints/technical drawings and calibrate equipment
Education
MBA - Project Management
Amberton University
TX01.2020
Bachelors - Molecular Biology, Biochemistry
East Central University
OK01.2014
Associate - Science
North Lake College
TX01.2011
Skills
- Bioinformatics techniques
- Laboratory equipment functions
- Research management
- Genetic engineering
- Research methodology
- Research and experiments
Certification
- Scientific Technical Writing, 2019
- PMP Certification, Expected 2025
References
- Sabal Adhikari, Senior Design Quality Engineer, sabal.adhikari@abbott.com, 9725187412
- Hannah Ritchie, Global Service Professional, hannah.ritchie@abbott.com, 9725186128
Career Experience
- Abbott Laboratories, Irving, TX, Scientist I, 06/01/21, Present, With minimal oversight, investigates, creates, and develops new methods and technologies for project advancement with limited assistance., Executes experiments, accomplishes established milestones, and summarizes data, interprets results., CFT member participates in project planning and updates; executes project plan with oversight from leaders; participates in defining project goals; develops timelines; comprehends resource requirements., Appropriately documents experimental results and procedures independently, including verification and validation reports according to established guidelines., Perform risk assessment and identifying control measure for the risk; Identify new risk and update the Risk Management Plan., Responsible for implementing and maintaining the effectiveness of the quality system., Presents complex technical information to internal and external group.
- Alcon Laboratories, Fort Worth, TX, Surgical IOL Lead, 03/01/18, 06/01/21, Conduct mechanical, material, and optical testing related to IOL devices in support of project activities in product design, technology development and product registration., Worked as a System Pro to perform qualification and validation activities IQ, OQ, PQ for IOL equipment., Applied Statistical Analysis, and six-sigma tool like 5 Whys, 5S, and capability analysis, Gage R&R etc. to solve engineering problems and improve process.
- Johnson & Johnson, Irving, TX, Quality Assurance, 11/01/14, 03/01/15, Hands-on experience in Incoming materials inspections, finished device and packaging QA inspection and testing., General Services Laboratory supporting production in QA Process monitor & Finished device monitor testing.
Timeline
Scientist I
Abbott Laboratories
06.2021 - Current
Surgical IOL Lead
Alcon Laboratories
03.2018 - 06.2021
Surgical IOL Principal Tech
Alcon Laboratories
12.2015 - 03.2018
Quality Assurance
Johnson & Johnson
11.2014 - 03.2015
- Scientific Technical Writing, 2019
- PMP Certification, Expected 2025
MBA - Project Management
Amberton University
Bachelors - Molecular Biology, Biochemistry
East Central University
Associate - Science
North Lake College
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