Shirshendu (Shawn) Saha
Biologist
Woodbridge,VA
Summary
With over 13 years of experience in the pharmaceutical industry, expertise in GxP systems compliance, quality assurance, and a foundational knowledge in biomolecular analysis are brought to the table, aiming to enhance research and development within the biotechnology and life sciences sectors. Involvement in notable projects, including Operation Warp Speed for COVID-19 vaccine manufacturing, highlights the capacity to excel in high-pressure environments and make significant contributions to globally impactful projects. This includes expertise in precise measurement methods, assay validation, data analysis, and the development of reference materials. With a thorough background in regulatory standards, method validation, quality systems development, and technical proficiency in cell, gene, and therapy, the pursuit is for a scientist role to advance the development of innovative therapies and technologies for cancer detection and monitoring. This professional stance, sharpened by fast-paced, high-stake projects and training in quality systems, positions the individual as a valuable contributor ready to engage in proactive, collaborative efforts to advance medical research. Focused on developing treatments that are effective and accessible, the goal is to enhance a culture of excellence and innovation within cancer biomarker programs and beyond. This includes engaging with stakeholders and disseminating results through written reports and oral presentations, addressing global patient challenges and advancing the life sciences field.
A hardworking Quality Assurance Manager is presented, possessing extensive knowledge in Cell and Gene Therapy inspections, capable of multitasking effectively. Proficient in managing long-term quality objectives and daily operations, with a successful track record in forecasting market trends and financial requirements. Experienced in developing an organization's quality strategy, procedures, and processes, monitoring quality performance from supply chain through the product development lifecycle. Responsible for developing and maintaining the Quality Management System in alignment with ISO 9001, other applicable standards, and business requirements. Overseeing a quality audit program to address non-conformities and fostering a culture of continuous improvement is a key role. With meticulous attention to detail and over a decade in the quality assurance domain, the individual is skilled in identifying issues, utilizing equipment for inspections, and developing and implementing solutions. Specializing in operational improvements, program implementation, and documentation, with a commitment to product quality and manufacturing process enhancement for customer satisfaction. This Quality Management professional is dedicated to efficiency, standardization, and maintaining ISO and QS 9000, Six Sigma Quality Systems, enhancing productivity and quality of finished goods through creative process improvements. Experienced in regulatory compliance, risk management, and corrective action programs, aiming to secure a leadership position that leverages interpersonal skills, time management, and problem-solving capabilities, contributing to team and company goals with a readiness to assume additional responsibilities for team success. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Thorough Quality Assurance Manager creates successful quality assurance strategies and processes. Accomplished at identifying deficiencies and initiating solutions to problems. Experienced performing both process and outbound inspections. Quality Management professional with successful career delivering efficiency and standardization, and maintaining all ISO and QS 9000 and Six Sigma Quality Systems. Drives smooth operation of production and manufacturing lines, coordinate efforts of employees and facilitate communication between management and production departments. Apply creativity in improving manufacturing process to achieve higher productivity and quality of finished goods. Experience in reviewing and interpreting regulatory and programmatic guidance, implementation of corporate compliance, risk management and corrective action programs. Precise Quality Assurance Manager proficient in all QA operations, policies and procedures. Experience hiring and developing individual team members. Committed to thoroughly assessing product quality and manufacturing processes to achieve excellent results and customer satisfaction. Methodical Quality Assurance Manager with superb problem-solving and analytical abilities. Keeps meticulous records and identify and troubleshoot problems. Specialties include operational improvements, program implementation and documentation. Quality control professional experienced in developing organization's quality strategy, procedures, and processes. Monitor quality performance from supply chain and throughout product development life cycle. Develop and sustain Quality Management System in accordance with ISO 9001 and other applicable standards and business requirements. Manage quality audit program to identify and resolve non-conformities and embed culture of continuous improvement.
Overview
14
14
years of professional experience
10
10
years of post-secondary education
Work History
Quality Assurance Manager
Merck Millipore Sigma
10.2022 - 12.2023
- Led team of 8 QA personnel, increasing team efficiency by 25% through optimized performance and resource utilization, surpassing organizational requirements.
Implemented and managed resource allocation tools, achieving 30% boost in both immediate and strategic operational efficiency, perfectly aligning with business needs.
Directly engaged with over 100 internal and external stakeholders, securing 98% satisfaction rate by consistently delivering standards exceeding Best-in-Class for quality and timeliness.
Oversaw more than 50 project assignments yearly, improving project completion rates by 20% through strict monitoring of progress, adherence to timelines, and guaranteeing high-quality outcomes.
Crucially contributed to QA department's budget formulation, managing to keep expenses within $2 million allocated budget, realizing cost reduction of 10%.
Leveraged analytics to identify trends and areas for improvement in quality and compliance, leading to 15% enhancement in overall operational efficiency.
Proactively communicated identified gaps in quality and compliance to senior leadership, spearheading 5 cross-departmental initiatives to drive systemic improvements.
Led over 20 comprehensive training sessions annually, significantly raising department’s expertise and compliance by 40%.
Directed QA department’s preparation and response for 12 regulatory inspections each year, maintaining 100% success rate in addressing observations and leading remediation efforts across functional teams.
Encouraged collaboration with more than 10 diverse local and global teams, leveraging cross-functional expertise to facilitate 25% increase in continuous improvement efforts.
Ensured transparent communication with senior leadership about quality, compliance issues, and progress on improvement projects, achieving 20% increase in project efficiency, ensuring strategic alignment and accountability. - Collaborated with cross-functional teams to identify root causes of product issues, leading to timely resolutions and continuous improvements
- Collaborated with cross-functional teams to develop and implement process and system improvements
- Assessed product quality by monitoring quality assurance metrics, reports and dashboards
- Evaluated interactions between associates and customers to assess personnel performance
- Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans
- Reduced defects in products by conducting thorough inspections and identifying areas for improvement
- Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards
- Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction
- Implemented new quality assurance and customer service standards
- Managed supplier relationships, enforcing strict standards for incoming materials and components to preserve product integrity and minimize rejections
- Applied coaching techniques and tools to support managers and team members in improving performance
- Conducted risk assessments to identify and mitigate potential quality issues
- Established and tracked quality department goals and objectives
- Mentored junior staff members in best practices for quality management, contributing to overall team growth and development
- Prevented costly recalls by proactively addressing potential risks before they escalated into larger issues
- Tracked quality issues with external customers, suppliers, and internal plant operations
- Reported production malfunctions to managers and production supervisors
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards
- Determined quality department standards, practices, and procedures
- Created and maintained quality management systems to align with industry standards
- Enhanced product quality by implementing comprehensive QA processes and procedures
- Evaluated new technologies and methodologies for potential implementation within the organization''s quality assurance program, staying ahead of industry trends
- Specified quality requirements of raw materials with suppliers
- Championed a customer-focused mindset across the organization by emphasizing the importance of consistently delivering high-quality products and services
- Trained team members on quality assurance principles, fostering a culture of accountability and high performance
- Gained extensive knowledge in data entry, analysis and reporting
- Paid attention to detail while completing assignments
- Applied effective time management techniques to meet tight deadlines
- Self-motivated, with a strong sense of personal responsibility
- Cultivated interpersonal skills by building positive relationships with others
- Organized and detail-oriented with a strong work ethic
- Proved successful working within tight deadlines and a fast-paced environment
- Used critical thinking to break down problems, evaluate solutions and make decisions
- Demonstrated respect, friendliness and willingness to help wherever needed
- Demonstrated leadership skills in managing projects from concept to completion
- Proven ability to develop and implement creative solutions to complex problems
- Learned and adapted quickly to new technology and software applications
- Passionate about learning and committed to continual improvement
- Completed paperwork, recognizing discrepancies and promptly addressing for resolution
- Demonstrated creativity and resourcefulness through the development of innovative solutions
- Developed and maintained courteous and effective working relationships
- Resolved problems, improved operations and provided exceptional service
- Strengthened communication skills through regular interactions with others
- Delivered services to customer locations within specific timeframes
- Demonstrated a high level of initiative and creativity while tackling difficult tasks
- Drove successful product launches with rigorous pre-release testing protocols that minimized post-launch issues
- Recorded, analyzed, and distributed statistical information
- Championed continuous improvement initiatives, consistently seeking ways to optimize operations for better results
- Conducted regular audits to ensure adherence to established protocols, maintaining consistency across the organization
- Facilitated communication between departments regarding quality concerns, fostering collaboration towards shared goals
- Investigated customer complaints and performed corrective actions to resolve quality issues
- Performed root cause analysis to identify and resolve quality issues and defects
- Assured consistent quality of production by implementing and enforcing automated practice systems
- Monitored staff organization and suggested improvements to daily functionality
- Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production
- Improved customer satisfaction ratings through meticulous attention to detail and consistent quality control measures
- Inspected products and worker progress throughout production
- Played a crucial role in refining company manufacturing practices by providing expert guidance on regulatory compliance matters
- Implemented corrective action plans based on audit findings, resulting in measurable improvements over time
- Established robust quality documentation systems that ensured traceability throughout the entire production lifecycle
- Streamlined testing processes by introducing automated tools, increasing efficiency and reducing errors
QC Cell Bio Supervisor
FUJIFILM Diosynth Biotechnologies
10.2020 - 09.2022
- Managed a team of quality control analysts to complete day-to-day tasks and work as a mentor for employee improvement.
- Carrying out various investigations during drug testing, including data collection, surveillance, and analysis resulting in drug release for patient safety and health.
- Proven track record of analyzing and interpreting complex data from laboratory experiments, contributing to scientific reports and peer-reviewed publications.
- Comprehensive understanding of regulatory guidelines and can independently develop, write, and execute methods, protocols, reports, and other related documents.
- Perform CAPA, OOS/ OOT investigation, and investigation/deviation tasks. Demonstrate initiative, courage, and continuous improvement throughout Investigation/corrective action lifecycles.
- Participate in complex projects and continuous improvement efforts: Administrating Compliance Wire for the QC team.
- Managed Capital Projects to bring new systems and equipment and managed change control procedures.
- Communicate effectively with executive management regarding task completion, roadblocks, and needs.
- Capable of handling complex issues and solving problems with minimum guidance.
- Coordinate Training of new analysts for general job duties.
- o Assisted in the streamlined onboarding of new quality control staff for the bioassay group.
- o Collaborate with Management/peers and coordinate all required training for current and future staff.
- o Provide feedback to Management on the developmental status of new staff during training sessions.
- o Work with the QA Training group to perform, maintain, and update all necessary documentation, including On-The-Job training, Training Materials, and Instructor-Led Training.
- o Demonstrate and train staff on general laboratory support activities, including reagent preparation, sample management, equipment maintenance, lab housekeeping, etc.
- o Supports authoring and revision of laboratory procedures and reports involving training.
- Represented the interests of the QC group on cross-functional teams, QA, and PD groups and in front of customers.
- Review data generated in GMP documents.
Lead Scientist
Thermo Fisher Scientific
04.2018 - 10.2020
- Managed multidisciplinary teams to design, develop, and release several highly effective new products that are widely used in pharmaceuticals and life science research
- Developed, Quantified, and Conducted Cell-based, Nucleic acid-based, Protein-based and Chemistry-based Assays to support Quality control of Biopharmaceutical products being Developed and Manufactured
- Maintained proper Client Communication and Relationships with complete, contemporaneous, and accurate records of all work performed
- Was Responsible for proficient Designing and Qualifying Assays for the release of drug products and release testing of intermediate and final biological products as well as their stability
- Performed routine assays and evaluate the results for testing including qPCR, ddPCR, agarose gel electrophoresis, SDS- PAGE, Immunoblotting, ELISA's ( quantitative determination of Residual Benzonase and Residual HEK and HCP), immunochemistry, quantitative protein assay (Bradford, Lowry, BCA), Viral infectivity cell assays ( TCID 50 for AAV, Infectious Unit Titer for Lentivirus, Baculovirus infectious titer assay, Plaque Assay to detect limit of residual rHSV, DNA sequence analysis, and Osmolality
- Managed test records, reagent preparation records, assay qualification protocol, and reports
- Also, write planned variances, and deviation reports, and track stability data
- Performed independent literature research to determine appropriate techniques to experiment with release testing
- Functioned as subject matter expert on QC assays
- Review data generated and troubleshoot issues
- Supervised Scientists and Lab technicians
- Plan and schedule direct reports and meet regularly
- Used LabWare LIMS Ad Hoc for Sample Logging and Contract Lab test Tracking
- Used SAP for a Work order, procurements, and facility notification
- Used Smartsheet to schedule laboratory testing and personnel management
- Working in a highly diversified team environment with excellent communication skills and interpersonal abilities such as empathy, confidence, flexibility, leadership, etc.
Senior Biologist
American Type Culture Collection
09.2016 - 04.2018
- Viral Nucleic Acid Extraction, Automated Nucleic Acid Extraction using QIACube and Molecular Assays Design
- Tissue Culture (Subculture, seeding density, cell counts)
- Managed PROJECT PROGRESS REPORT and was responsible for DOCUMENTATION including analytical data, schedules, forms, and PPT presentations to senior management
- Responsible for growth of Viruses in Adherent Cells, MOI, harvesting (by scraping, trypsinization), and Vialing
- Performed TCID50, Fixing & Staining Plates for TCID50
- Microscopy (Fluorescent/Confocal)
- Performed IQ/OQ on lab equipment (Cellometer, Centrifuge, Incubator, and Refrigerator)
- Quantitative Analysis of Nucleic Acid using Droplet Digital PCR
- PCR Processing RNA for Next Generation Sequencing using New England BioLab Inc
- (NEB) NEBNext Ultra II RNA Library Prep Kit
- Illumina MiSeq platform
- Growth of Viruses in Allantoic Fluid of Eggs
- Titration of Viruses Grown in Allantoic Fluid of Eggs
- Hemagglutination assay
- Immunology Lab Affinity Purification of Monoclonal Antibody Using Spin Column or Magne Protein Beads; Mouse: IgG
- Room champion; maintain 6S standard in the lab
- Manufacturing of Nucleic Acids Mix DI Material for Microbiome Products
- (Ex: Skin and Vaginal Nucleic Acid Microbiome Standard mix)
- Manufacturing of Live Bacterial Microbiome Standard Products
- (Ex: Skin and Vaginal whole cell microbiome standard mix)
- Manufacturing of Virome Standard Products (Whole-cell virus standard mix and Virus Nucleic acid standard mix)
- Assay development for Nexcelom Cellometer to count Bacteria, Yeast, and Protist
- Analysis of Whole Genome Sequencing Data and 16S of Microbiome Products
- Designing Synthetic Molecular Standard Constructs for microorganisms
- Nucleic Acid Analysis of Genomic DNA Using Advanced Analytical Technologies Fragment Analyzer
- Present scientific/technical presentations on Microbiome, Virome, and Molecular Standard ATCC product line
- Respond to customer application questions via telephone or email
- Extract DNA/RNA for both Bacteria and Viruses and prepare samples for Next-Generation Sequencing.
Associate Scientist/ Study Director/ Clinical Trial Sub-Investigator
MicroBioTest, Division of Microbac Laboratories, Inc.
11.2009 - 08.2016
- Provided extensive research and testing of a wide range of antimicrobial products in compliance with the Food and Drug Administration (FDA), EPA, and international guidelines, encompassing the good laboratory practice (GLP) quality system; and utilized AOAC Official Methods of Analysis, OECD, European methods, and Air sanitizer testing
- Facilitated and managed training and guidance for new hires on job duties and performance, including assigning laboratory tasks for the group, managing schedules, and initiating follow-ups on assignments
- Worked collaboratively with the Environmental Protection Agency (EPA) to develop and implement updated guidelines for assessing antibacterial agents (C.difficile and Mycobacterium testing)
- Proficiently draft and update standard operating procedures (SOPs) institution-wide
- Assist clients in creating protocols based on ASTM and International testing methods to efficiently evaluate products for antimicrobial efficacy utilizing FDA/EPA and International regulations
- Managed the entire laboratory operations for senior management
- Proficiently maintained BSL-3 organisms, such as Mycobacterium tuberculosis
- Worked on daily infection-causing microorganisms (S.aureus, E.coli, S.enterica, and P.aeruginosa), fungal culture (T.mentagrophytes), and Mycoplasma (M.gallisepticum); as well as with antibacterial resisting stains, such as MRSA, MRSE, and VRE
- Successfully performed roles as a group participant inside the multidisciplinary group and actively participated in every step of product improvement and launching
- Clinical Trial Sub-Investigator: Assumed full accountability in handling the preparation of media and reagents; screening and consenting test subjects in adherence to CRF; and maintaining laboratory logs and ledgers, as well as key inventory and supplies following the GLP method
- Ensured strict adherence to good clinical practice (GCP) guidelines in planning and performing pre-operative skin scrub and hand wash studies
- Proficiently recorded data in CRFs and reviewed data for completion in strict compliance with the protocol
- Manage Trial Master File (TMF) / Electronic Trial Master File (eTMF) and review site documents for accuracy
- Conduct on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigator sites
- 3+ years of monitoring experience in a Clinical Research Organization (CRO).
Education
Master of Science in Biotechnology - Computational Biology
Johns Hopkins University
Baltimore, MD 01.2012 - 08.2016
Bachelor of Science in Biology -
Bloomsburg University
Bloomsburg, PA 01.2004 - 12.2008
Skills
Proficient in preparing comprehensive responses to audit findings, demonstrating an in-depth understanding of regulatory requirements and best practices in quality assurance
undefinedVirology
- Cell Culture
- Cell Bank Maintenance
- Cell Cryopreservation and Revival
- Virus Propagation in Tissue Culture
- Virus Cryopreservation and Revival
- TCID50
- Plaque Assay
- Lentivirus Infectious Unit Titer
Microbiology
- Aseptic Techniques
- Gram Staining
- Media and Reagent Preparation
- Bacterial growth
- Bacterial Culture Maintenance
- Bacterial Cell Cloning
- Isolating Colonies
- Serial Ten-Fold Dilutions
- Spore Staining
- Acid-Fast Staining
- Wet Mount Technique
- Phase Contrast Microscopy
Computational Biology
- Sequence Data Formats and Processing
- Automated Bioinformatics Workflows
- Microbiome Analysis Pipelines
- Phylogenetic Reconstruction Methods and Programs
- CLC Bio Work Bench
- Blast
Laboratory Equipment
- Spectrophotometer
- ISE Electrode
- Atomic Absorption Spectra
- Mass Spectrometer
- HPLC
- IR Spectrum
- Thermo Cycle
- PH Meter
- Anaerobic Chamber
- Flow Chemistry
- Chemical Titration (Hydrogen Peroxide, Sodium Hypochlorite, and Glutaraldehyde)
- Agilent 2100 Bioanalyzer
- Agilent 4200 TapeStation
- Illumina MiSeq platform
- Advanced Analytical Technologies Fragment Analyzer
- Qubit Fluorometer
- Implen Nanophotomer
- Applied Biosystem 7500 Real-Time PCR
- Bio-Rad CFX 384 thermocycler
- Various Multichannel Electronic Pipettes
Linkedin Certifications
- Quality Management for Operational Excellence
- Building a Trustworthy Reputation
- Uncovering Unconscious Bias in Recruiting and Interviewing
- Transforming Manager to leader
- Time management Fundamentals
- Powerful Prioritization with the 80/20 Rule
- Managing in Difficult Times
- Leadership through Feedback
- Customer Service: How to Manage Your Customer Queues
- Confronting Bias: Thriving Across Our Differences
- Become a Manager your team Loves
- Root cause Analysis: Getting to the Root of Business Problems
- Essential of Team Collaboration
- Be an Effective Hybrid or Virtual Employee
- Communication Tips
Molecular Biology
- DNA Extraction
- RNA Extraction
- Next Generation Sequencing
- Synthetic construct of Microbiological Standard
- Bacterial Cloning
- Primer and probe assay design
- Droplet Digital PCR
- QPCR
- Endpoint PCR
Affiliations
ASQ
Timeline
Quality Assurance Manager
Merck Millipore Sigma
10.2022 - 12.2023
QC Cell Bio Supervisor
FUJIFILM Diosynth Biotechnologies
10.2020 - 09.2022
Lead Scientist
Thermo Fisher Scientific
04.2018 - 10.2020
Senior Biologist
American Type Culture Collection
09.2016 - 04.2018
Master of Science in Biotechnology - Computational Biology
Johns Hopkins University
01.2012 - 08.2016
Associate Scientist/ Study Director/ Clinical Trial Sub-Investigator
MicroBioTest, Division of Microbac Laboratories, Inc.
11.2009 - 08.2016
Bachelor of Science in Biology -
Bloomsburg University
01.2004 - 12.2008
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