Project Management Quality Assurance
Resume:
Qualifications Summary
• Solid history of success in developing science strategies, managing fundraising activities for research and development, designing molecular diagnostic kits, and performing screening of compounds for drug efficacy and cytotoxicity.
• Demonstrated expertise in overseeing technical projects from inception to completion using best practice project management methodologies and ensuring successful delivery on time and within budget.
• Adept at building intracellular assay models/infrastructure systems to improve engineering and manufacturing functions.
• Visionary leader with expertise in recruiting, training, mentoring, and leading teams to win shared visions and goals.
Areas of Expertise/ Skills
Biotechnology Research &
Development
Drug Discovery and
Diagnostics
-Team Training &
Leadership
Flow Cytometry
Cell Biology/Biochemistry Assay
Development
Cell & Molecular Biology Techniques
Quality Assurance & Control
Research Project Management
Computer Skills-MS Project
- Regulatory Compliance
- Health & Safety
Compliance
- Scientific Data
Analytics
Gene Cloning, Cell Culture Cell & Molecular Biology - Project Planning & Execution
Career Experience
Project Management Consultant, FL 2023-current
Beckman Coulter Inc., Miami, FL Senior Development Scientist 2022-2023 As a Senior Development Scientist, I work in a team environment to develop new products, evaluate and implement new technologies, and products, and participate or lead in supporting post-launch process improvement and quality issues. Other responsibilities include:
• Plan and run laboratory experiments. Collecting data and interpreting results.
• Writing clear documentation SOPS, Protocols, Project Review Documents, etc.
• Participate in project management meetings and planning studies for the development, evolution, and optimization of assay(s).
• Write project documentation and SOPs in compliance with relevant procedures.
• Support post-launch to resolve performance and /or quality issues. Venkita Subbulakshmi
MSc, PhD, MBA Certified PMP professional.
***********@*******.*** *561-***-****
LinkedIn URL • Boca Raton, FL 33496 Green
Card/Permanent Residency in USA
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Chromous Biotech Private Limited, Bangalore, India Scientific Project Manager 2011 to 2021 I have formulated and employed science strategies and organized fundraising for research and development. I have organized effective training and development programs for junior staff to boost knowledge and performance. I have spearheaded projects from start to finish with technical leads using best practice project management methodologies, ensuring successful delivery on- time and within budget and development of QA resources, which led to the successful completion of releases. I created and analyzed documentation for lot release as per FDA, USP, and ISO standards. I have organized and steered team meetings to discuss innovative ideas for process improvement and enhance capabilities related to problem-solving, plan updates, decision- making, and escalations.
• Developed, tested, and launched infrastructure systems that optimized business and manufacturing functions.
• Secured research grant, valued at $100K while creating and delivering molecular diagnostic kit for malaria.
• Received excellent reviews for innovation and technology.
• Designed and manufactured RT-PCR Test kits for ICMR (India), for COVID-19. AstraZeneca India Private Limited, Bangalore, India Senior Research Scientist 2001 to 2011 I led the management of TI/TV in drug discovery and was in charge of developing and implementing intracellular assay models. I conducted compound screenings to assess drug efficacy and cytotoxicity using various intracellular models. Additionally, I designed and carried out experiments to investigate scientific phenomena, gathered and analyzed data to explain these phenomena, and authored scientific articles for publication. Furthermore, I contributed to curriculum development, and graduate training, and served on the university committee.
Delivered research work and active member of the team in creating FDA-approved New Chemical Entity (NCE) for the treatment of multi-drug-resistant tuberculosis which is in Phase III Clinical Trial.
• Provided strategic leadership to a research team of employees and encouraged them to achieve set goals.
• Improved overall operational efficiency by identifying and mitigating potential risks. Additional Experience as Research Technologist/Lab Manager at Cleveland Clinic Foundation, OH P a g e 3 3
Education
Master of Business Administration (MBA)
Indian Institute of Business Management
Delhi, India
Doctor of Philosophy (PhD) in Life
Sciences Trinity College, Seychelles
Master of Science (MSc) in Microbiology, Biochemistry, and Immunology Tamil Nadu Agricultural University, Bachelor of Science (BSc) in Biochemistry and Microbiology Tamil Nadu Agricultural University - Coimbatore, Tamil Nadu, India. Honors & Awards
• Merit Scholarship: Awarded National Merit Scholarship for academic excellence in High School. The Scholarship funded my undergraduate and post-graduate studies.
• Council of Science and Industrial Research Fellowship, Government of India: Competitive Fellowship awarded for doctorate studies and research.
• Excellence Award for Research, AstraZeneca: Awarded the Excellence Award for Research for solving a critical scientific problem.
• Presented Research article/ poster in Keystone Symposium 2008, Vancouver, Canada.
• Invited Speaker for EU-India Science and Technology Conference, Paris, France. Oct 2013. Language
English and
Tamil:Expert
Bengali: Fluent
Hindi: Intermediate
Kannada:Intermediat
French: Beginner
Publications
https://www.researchgate.net/profile/Venkita-Subbulakshmi
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