Kruti Patel
Foxborough,MA
Summary
Possessing dual Master’s within areas of Biochemistry & Microbiology with strong healthcare clinical diagnostics background for 14 plus years. Exposure to different areas of diagnostics has helped to honor the expertise of working in fast paced work environment developing skills in areas of clinical diagnostics, patient care management, safety management, quality control and client support. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
17
17
years of professional experience
Work History
Biological Chemical Engineer/Biochemist II
SIEMENS HEALTHINEERS
05.2022 - Current
- Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
- Audit & Review formulation records and witness instrument data for GMP and GDP compliance
- Responsible for scheduling and coordinating daily production of immunoassays & other lab diagnostics components for team of 15+ technicians and execute basic supervisory duties
- Mentor and coach staff members for ongoing growth and leadership
- Coordinate with planning and forecast team to facilitate production of materials
- Support Change control and revise SOPs, forms, laboratory test records as required using appropriate electronic systems
- Revising BOM updates in order
- Actively taking part with Change control projects
- Escalate issues and potential solutions to laboratory management in timely manner
- Demonstrate critical reasoning, strategic thinking, problem solving, troubleshooting, influencing and decision-making skills
- Experienced in drafting SOP, Quality Notifications, Laboratory records, test instructions, testing Manufacturing deviations(TMD)
- Manage inventory and review material requirements/production forecasts using SAP
- Responsible for drafting and reviewing product defect/deviation notifications and investigation reports & Quality Notifications
- Collaborate with Quality Assurance/Control, Technical Operations, Fill/Pack, and Process Engineering groups on cross-functional projects and teams
- Involve overseeing production of ADVIA Centaur and Atellica IM quality control components across extensive assay menu including cardiac biomarkers, infectious diseases, and therapeutic drug monitoring product
- Experience in cGMP lab setting with aseptic experience
- Effective in prioritizing, shows appropriate sense of urgency around prioritized tasks
- Flexibility and ability to prioritize and manage multiple tasks simultaneously
- Demonstrated excellence in written and verbal communication
- Ability to effectively communicate at all levels in organization – oral and written
- Demonstrated ability to work cross-functionally
- Highly motivated, driven and have passion to be part of fast-paced team
- Troubleshoot any investigations associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders and identify appropriate corrective and preventative actions
- Perform data review and author analytical reports or data summaries
- Quality Auditing
- Planning & Logistics
- Good Manufacturing Practice (GMP) compliance
- Good Document Practices (GDP)
- Good laboratory practices (GLP).
- Improved production efficiency by optimizing chemical processes and implementing innovative solutions.
- Researched and developed novel manufacturing processes to reduce production time.
- Troubleshot complex issues within chemical processes, identifying root causes of problems and swiftly implementing effective resolutions.
- Adhered to various Safety Management Protocol standards.
- Delivered successful pilot-scale trials for new products before full-scale implementation in the manufacturing facility.
- Evaluated production activities and provided suggestions for quality improvements and cost control.
- Maintained accurate documentation of all relevant project information including design specifications, test results, process adjustments, and final outcomes.
- Implemented quality control measures to minimize defects and ensure consistency across batches of produced materials.
- Collaborated with cross-functional teams to develop new products, meeting market demands.
- Coordinated workloads to fit with tight deadlines and employee schedules.
- Established proper processes to meet production capacity demands.
- Saved on operating costs through resource optimization and energy-efficient process modifications.
Biological Chemical Engineer
Siemens Healthineers
05.2022 - Current
- RISK COACH professional
Customer Support Specialist
LIFELABS
04.2021 - 04.2022
- Working on COVID projects
- Mobile Lab technician under Ministry of Education project
- Project funded by Ontario government for Ontario school students and families.
- Served customer account and technical needs across Ontario & Vancouver,BC 600+ daily calls, consistently meeting productivity and quality targets.
- Developed strong relationships with clients, resulting in repeat business and positive feedback.
Laboratory Technician
THE SICKKIDS HOSPITAL
05.2010 - 2020
- 10 Years of experience in various lab departments
- The Microbiology Lab: Experience in EPIC Beaker system from receiving, set up, processing & shipping clinical patient samples
- Worked in lab areas of Bacteriology, serology, molecular microbiology & COVID
- Following Quality Control procedures and SOP’s
- Genome Diagnostics Lab: DNA Techniques of automated DNA extraction from whole blood by Qiagen Symphony extractor
- Successfully learned Shire LIS system and imbibed EPIC beaker training with new modifications
- Manual extractions of various patient sample types: Bloods, cultured prenatal pellets, Fibroblasts, Direct CVS, Amniotic fluid, Cheek brush, Cheek swabs, Paraffin, Blood spots, Fresh and Frozen tissues, Sorted cells
- Infectious Diseases Lab: HIV Viral-load Lab (Infectious diseases department
- Laboratory Technician
- Supervised medical laboratory activities in clinical lab
- Expertise in areas of Specimen Accession, Receiving, Processing and Storage
- Proficient in LIMS database like Lab-ware
- Excellent Communication and interpersonal skills
- Proficient e-mail etiquettes with speed typing skills
- Analytical and time management skills developed by handling several research and lab projects
- Regulation and smooth working of lab independently and in team.
- Performed testing and quality control using approved laboratory procedures and instrumentation.
- Documented information by maintaining daily logs and equipment record books.
- Contributed to a safe working environment by consistently following established safety procedures and guidelines within the lab setting.
- Maintained documentation on tests performed in lab.
- Calibrated and maintained instruments to keep equipment fully operational.
- Trained new associates in laboratory procedures and standards.
- Completed quality documents and input and saved quality data in appropriate locations.
- Adapted quickly to changes in test protocols or methodologies, maintaining productivity during periods of transition.
- Offered excellent customer service when interacting with clients or stakeholders regarding test results or related inquiries.
- Maintained consumables and glassware inventory by receiving and inventorying incoming shipments.
- Streamlined sample processing for faster turnaround times, resulting in improved customer satisfaction.
- Implemented inventory management system to maintain optimal levels of supplies, preventing delays in testing processes.
- Improved interdepartmental communication by collaborating closely with other lab personnel on shared projects and goals.
- Prepared samples for shipping and disposed of bodily fluids in proper containers.
- Processed patient specimens according to priority and documented results.
- Researched new methods and techniques to improve laboratory procedures.
- Troubleshot and resolved equipment and process issues.
- Participated in lab meetings and project presentations.
- Coordinated and managed laboratory projects and experiments.
- Operated and performed preventative maintenance on laboratory equipment and instruments.
- Monitored and documented safety standards to verify compliance.
- Participated in research projects by designing and executing experiments.
Research Assistant
UMASS DARTMOUTH
01.2007 - 12.2009
- Practical experience in expression and purification and analysis of proteins by SDS-PAGE and Chromatographic systems
- Aseptic Preparation of plates and liquid media for cell-culture
- Assisted undergraduate students in innovating expression and purification techniques of other proteins in bacterial cell system
- Managing inventory of autoclave sterilized product, chemicals, and laboratory supplies
- Prepare and present research manuscripts and presentations
- Develop and maintain research databases.
Education
Masters of Science - Chemistry and Biochemistry
University of Massachusetts Dartmouth
North Dartmouth, MassachusettsMasters of Science - Microbiology
University of Gujarat
Gujarat, India06.2002
Bachelors of Science - Microbiology
University of Gujarat
Gujarat, IndiaSkills
- Trained in Epic Beaker systems and successfully learnt the LIS systems Labware and SHIRE
- DNA extraction, gel electrophoresis, PCR, DNA and plasmid isolation
- Gel Electrophoresis and SDS PAGE, Recombinant DNA plasmid construction (cloning) and primer design Protein expression and purification techniques in bacterial cells
- Experience working with all different types of Human specimens Determination of unknown nucleic acid and protein concentrations
- Maintenance of aseptic environments & working experience of BSL-2 & 3
- Bioassays and bioactivity of pathogenic species of Ecoli
- Metal analysis by Atomic adsorption spectrophotometer (amount of metal absorbed in bacterial cells)
- Abbott’s m2000 real time HIV-1 real-time RT-PCR nucleic acid quantification method Qiagen Symphony automated DNA extraction analyzer
- UV/Vis Spectroscopy , chromatographic techniques by HPLC
- Knowledge of GMP and GLP techniques
- Protein Purification
- Quantitative skills
- Experimental design
- Research and publication
- Research management
- Cell Culture Techniques
- Spectroscopy Techniques
- Critical Thinking
- Effective Multitasking
- Self-Directed and Motivated
- Strong Work Ethic
- Chromatography
- Report Preparation
- Team Collaboration
- Routine Laboratory Operations
- Molecular Biology
- Process Development
- Technical oversight
- Recordkeeping
- Molecular Bench Work
- New treatment development
- Health and Safety Regulations
- Cell Culture
Research
Possible role of Iron chelation on inhibition of uropathogenic E.coli strain by cranberry phenolics majorly by proanthocyanidins, Iron sequestarisation, considered main reason for providing pathogens with their pathogenicity. Worked with Biosafety Level-2 human pathogens. Isolation, expression and purification of a novel periplasmic Iron binding protein HaFBP in bacterial cell system and competitive iron binding with cranberry phenolics Molecular modeling and docking of the expressed “Ferric binding Protein” with ligands like Cranberry flavonols.
Professional Experience
- Siemens Healthineers (East Walpole, MA, USA) 5/2022-present
- Biological Chemical Engineer
- RISK COACH professional
- LIFELABS 4/21-4/2022
- Customer Support Specialist (Remote)
- Working on COVID projects
- Mobile Lab technician under Ministry of Education project
- Project funded by Ontario government for Ontario school students.
- And families.
- THE SICKKIDS HOSPITAL (TORONTO, Ontario, Canada) 10 Years of experience in various lab departments.
- The Microbiology Lab 07/19-10/20
- Experience in EPIC Beaker system from receiving, set up, processing & shipping clinical patient samples. Worked in lab areas of Bacteriology, serology, molecular microbiology & COVID.
- Following Quality Control procedures and SOP’s.
- The Genome Diagnostics Lab 04/18-07/19
- DNA Techniques of automated DNA extraction from whole blood by Qiagen Symphony extractor
- Successfully learned the Shire LIS system and imbibed the EPIC beaker training with the new modifications.
- Manual extractions of various patient sample types: Bloods, cultured prenatal pellets, Fibroblasts, Direct CVS, Amniotic fluid, Cheek brush, Cheek swabs, Paraffin, Blood spots, Fresh and Frozen tissues, Sorted cells.
- Infectious Diseases Lab 03/10-03/18
- HIV Viral-load Lab (Infectious diseases department
- Laboratory Technician
- Supervised medical laboratory activities in a clinical lab.
- Expertise in areas of Specimen Accession, Receiving, Processing and Storage.
- Proficient in LIMS database like Lab-ware
- Excellent Communication and interpersonal skills.
- Proficient e-mail etiquettes with speed typing skills.
- Analytical and time management skills developed by handling several research and lab projects.
- Regulation and smooth working of the lab independently and in a team.
- UMASS DARTMOUTH, North Dartmouth, MA, USA
- Research Assistant 01/07 – 12/09
- Practical experience in expression and purification and analysis of proteins by SDS-PAGE and Chromatographic systems.
- Aseptic Preparation of plates and liquid media for cell-culture
- Assisted undergraduate students in innovating expression and purification techniques of other proteins in bacterial cell system.
- Managing inventory of autoclave sterilized product, chemicals, and laboratory supplies.
- Prepare and present research manuscripts and presentations.
- Develop and maintain research databases.
References
Available upon request.
Timeline
Biological Chemical Engineer/Biochemist II
SIEMENS HEALTHINEERS
05.2022 - Current
Biological Chemical Engineer
Siemens Healthineers
05.2022 - Current
Customer Support Specialist
LIFELABS
04.2021 - 04.2022
Laboratory Technician
THE SICKKIDS HOSPITAL
05.2010 - 2020
Research Assistant
UMASS DARTMOUTH
01.2007 - 12.2009
Masters of Science - Chemistry and Biochemistry
University of Massachusetts Dartmouth
Masters of Science - Microbiology
University of Gujarat
Bachelors of Science - Microbiology
University of Gujarat
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