Ritu Mali
vista,CALIFORNIA
Summary
Results-oriented biotechnology professional with a Master’s degree and 3+ years of industry experience in Molecular Diagnostics, Quality Control, and Process Validation. Demonstrates strong expertise in designing and executing experimental protocols, data analysis, and quality control within GMP/GLP-regulated environments. Adept at troubleshooting technical issues, collaborating across departments, preparing detailed documentation, and optimizing laboratory procedures to advance molecular biology projects. Committed to scientific excellence, organizational efficiency, and continuous improvement in support of innovative diagnostic product development.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Research Associate I
Roche Dia (GenMark Diagnostics)
Carlsbad, USA
08.2024 - Current
- Designed, executed, and reviewed nine process validation plans and protocols (PQ/PPQ) for new and existing manufacturing processes, leading to the successful validation of four new products and the re-validation of five existing products.
- Conducted risk assessments, including Failure Mode and Effects Analysis (FMEA), to identify and mitigate over 20 potential failure modes, which reduced the risk of process errors by 15%.
- Analyzed process data from over 100 production batches to identify areas for improvement, resulting in the implementation of cost-effective techniques that reduced process variability by 10% and waste by 12%.
- Collaborated with cross-functional teams from R&D, Quality, Manufacturing, and Regulatory Affairs to support five product development projects and ensure compliance with regulatory standards.
Quality Control Specialist
GenMark Diagnostics (Roche Group)
Carlsbad, USA
06.2023 - 08.2024
- Executed 7 different QC assays across an average of 30 manufacturing batches per month, consistently achieving reliable results within stringent industry and company specifications.
- Actively participated in over 10 departmental projects, troubleshooting experimental issues and identifying solutions for over 25 Out-of-Specification (OOS) and non-conformance Report (NCR) investigations.
- Proficiently analyzed and interpreted data to identify root causes, implementing 7 product and manufacturing improvements that reduced defect rates by 10%.
- Performed over 15 validation and stability studies, executing protocols, analyzing data, generating comprehensive reports, and initiating 63 non-conformances for the Material Review Board (MRB).
Regulatory Affairs Associate
GenMark Diagnostics (Roche Group)
Carlsbad, USA
10.2022 - 05.2023
- Developed and implemented a centralized regulatory database system using SQL, improving the management and archival efficiency of regulatory information for over 50 IVD products by 25%.
- Ensured regulatory compliance for IVD products across EMEA and APAC regions, demonstrating attention to detail and adherence to regulations.
Innovation Laboratory Intern
Volition America
Carlsbad, USA
05.2022 - 08.2022
- Maintained and treated 6 different cell lines and utilized molecular biology techniques (e.g., next-generation sequencing) in over 20 laboratory experiments.
- Planned and organized 15+ Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP) documentation, and pre- and post-lab activities, streamlining lab operations by 15%.
- Contributed to 2 clinical trials by screening over 100 plasma samples and analyzing data using statistical methods to identify key biomarkers.
Molecular Biologist
Lifenity Wellness International Ltd
Mumbai, India
10.2020 - 01.2021
- Contributed to 2 clinical trials by screening over 100 plasma samples and analyzing data using statistical methods to identify key biomarkers.
- Conducted Molecular Biology Research, investigating CT values of extracted RNA of COVID-19 samples, showcasing expertise in molecular biology techniques.
- Designed and executed experiments to investigate biological processes.
- Performed quality analysis on RT-PCR machines.
Education
Master of Biotechnology -
CALIFORNIA STATE UNIVERSITY
San Marcos, CA05.2023
Bachelor of Engineering - Biotechnology
SHIVAJI UNIVERSITY
India05.2020
Skills
- Process validation
- Risk assessment
- Regulatory compliance
- Data analysis
- Molecular biology lab techniques
- Quality control
- Strong multitasking and prioritization skills
- Proactive problem-solving and protocol optimization
Certification
- Google Data Analytics Professional Certificate, Google
- Writing in the Life Sciences, Stanford University
- Genes and Human Condition, University Of Maryland
Languages
- English, Fluent
- Marathi, Native
- German, Intermediate
- Hindi, Native
- Spanish, Basic
Honors And Awards
Al Kern Award for Best Master's Thesis in Biotechnology, California State University, San Marcos, CA, 05/23, Awarded for superior integration of Science, Technology, and Business practices.
Accomplishments
Al Kern Award for Best Master's Thesis in Biotechnology, California State University, San Marcos, CA (2023)
Awarded for superior integration of Science, Technology, and Business practices.
Languages
English
Full Professional
German
Professional
Hindi
Native/ Bilingual
Affiliations
Site Lead - Roche Young Professionals JAN 2023- Present Roche – Networking, Professional Development, and Outreach Carlsbad, CA
○ Spearheaded the Roche Young Professionals + Business Resource Group in San Diego, building and leading a diverse team of 8 leaders to drive strategic efforts supporting Roche’s 10-year blue multiplier goal.
○ Built and managed a team of leaders from 5 different sites across the US, establishing designated roles, responsibilities, and goals for networking and partnerships, resulting in a 20% increase in inter-site collaboration events.
○ Initiated and executed over 15 outreach activities for advanced professional development, removing barriers and contributing directly to Roche’s long-term talent development objectives.
Timeline
Research Associate I
Roche Dia (GenMark Diagnostics)
08.2024 - Current
Quality Control Specialist
GenMark Diagnostics (Roche Group)
06.2023 - 08.2024
Regulatory Affairs Associate
GenMark Diagnostics (Roche Group)
10.2022 - 05.2023
Innovation Laboratory Intern
Volition America
05.2022 - 08.2022
Molecular Biologist
Lifenity Wellness International Ltd
10.2020 - 01.2021
Master of Biotechnology -
CALIFORNIA STATE UNIVERSITY
Bachelor of Engineering - Biotechnology
SHIVAJI UNIVERSITY
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