Divya Srinivasan
Ellicott City,Maryland
Summary
Accomplished Project Management Professional (PMP) with a robust background in Biological & Biomedical Engineering and extensive experience in the pharmaceutical and biotechnology sectors. Adept at seamlessly integrating technical expertise with project management acumen to drive successful outcomes. Proven track record in leading cross-functional teams, managing complex process development projects, and implementing innovative solutions.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Engagement Manager (Pro Bono Consulting)
Impact Consulting
08.2023 - Current
- Led a team of 5 consultants for creating a business plan, performing industry and market analysis, competitive intelligence, financial analysis and developing a sales strategy for an early-stage tech start-up developing a new AI tool.
- Met with clients to understand needs and develop proactive solutions.
- Led client and team meetings, settings agendas, facilitating meetings, sending out agendas, and tracking goals and action items.
- Liaised with leadership and project team to ensure project outputs include strategically sound and actionable recommendations and answers for client business questions.
- Support team members as a workstream lead, both coordinating and guiding the work of more junior staff members and effectively communicating as a project leader.
- Established, initiated and optimized business development strategies based on company targets, product specifications, market data, and budget factors.
- Create and present client-ready materials, including research materials, interim deliverables, and final project reports.
- Managed project methodology and schedule and oversaw successful project completion that enabled client to build a business plan to raise capital.
Scientist (Contract)
Sanofi
03.2023 - 08.2023
- Managed the project of a new laboratory expansion by planning the process workflows for manufacturing of vaccines, leading procurement efforts and interfacing with vendors for customized product requirements.
- Led team meetings by preparing meeting agendas, facilitating meetings, documentation of minutes and tracking progress on action items.
- Managed communication between different teams by preparing memos for CMC activities.
- Worked on key R&D projects in the Vaccine Drug Product Development group for Meningitis vaccines by performing market study of new automation technologies to streamline processes for vaccines formulation.
- Designed and executed studies for novel process analytical technologies and utilized ELNs and Laboratory Information Management Systems (LIMS) for managing the laboratory workflow and inventory.
- Authored SOPs and technical reports for new lab-scale processes.
- Initiated the use of AI to predict filtration scale up and membrane fouling for sterile filtration applications by building an Artificial Neural Network (ANN) model in Python to improve existing filtration fouling prediction process.
Bioprocess Scientist
Membio
11.2021 - 03.2023
- Successfully provided leadership on 4 critical projects for technical product development of a novel single-use bioreactor system that enables cost-effective scalable biomanufacturing for cell and gene therapies.
- Developed project plan, budget, timeline and resource requirements for R&D projects.
- Spearheaded commercial development of the product, making strategic research decisions and mitigating risks.
- Gathered in-depth qualitative and quantitative market research data to study the competitive landscape for single-use bioreactor systems.
- Applied statistical analysis such as hypothesis testing, ANOVA, t-tests on critical scientific data to determine product development strategy.
- Led upstream process development for mammalian cell culture processes with CHO, HEK293 and T-cells for bioreactor scale-up studies.
- Used Python and R to analyze process data, perform process monitoring, and multivariate data analysis for cell culture process parameters and data visualization.
- Authored SOPs for laboratory procedures and technical reports on research findings.
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
Process Engineer
PM Group
01.2018 - 02.2020
- Led projects comprising of cross-functional teams as a project manager and handled budget, tracked progress of engineering deliverables
- Monitored and tracked project status, and managed the change control process by preparing change requests, and keeping change log updated
- Led project status meetings, and collaborated with stakeholders to track issues, and discuss recommendations for resolving issues.
- Managed client engagements by leading deliverable presentation meetings and built successful relationships with clients.
- Collaborated with stakeholders to conduct design reviews and conduct risk assessments.
- Handled the technology transfer of mRNA vaccine production processes and performed engineering design for the manufacturing facility for a novel personalized cancer vaccine for a top-tier biopharmaceutical company.
- Conducted feasibility studies and evaluated proposed project investments by conducting cost-benefit analyses.
- Developed customized process systems by liaising with product vendors for automated manufacturing solutions for biopharma clients.
- Developed documentation, diagrams, and specifications to meet project requirements and regulatory standards.
- Improved manufacturing capacity by diagnosing critical issues with medical device production process by troubleshooting with root cause analysis and value stream mapping manufacturing processes.
- Conducted HAZOP studies and participated in safety reviews.
- Collaborated with cross-functional teams to develop and implement process changes.
Process Engineer
Global Process Systems
08.2011 - 08.2013
- Built process simulations for large-scale floating crude oil processing platforms with capability of producing 60,000 barrels of oil/day through ASPEN HYSYS and ASPEN PLUS.
- Performed in-depth engineering technical analysis to provide optimized process solutions to reduce equipment costs.
- Managed third-party contractors, inspecting completed work and ongoing efforts to confirm quality and adherence to prescribed guidelines.
- Interfaced with cross-functional teams to verify application of technical details.
- Participated in project reviews to enable ongoing status tracking and reporting.
Education
Master of Engineering - Biological And Biomedical Engineering
McGill University
Montreal, Canada09.2022
Master of Science - Chemical Engineering
University of California - Davis
Davis, CA09.2017
Bachelor of Engineering - Chemical Engineering
National University of Singapore
Singapore 05.2011
Skills
- Technical Expertise: Highly motivated individual who has in-depth knowledge of vaccines and biologics development with hands-on experience in process optimization across mRNA, viral vector vaccines, in scale-up and formulation
- Leadership & Mentoring: Proven ability to lead, guide, and mentor teams, promoting a collaborative and innovative work culture
- Communication and Collaboration: An excellent communicator recognized for ability to establish and maintain effective working relationships across cross-functional teams, global colleagues, and vendors
- Strategic Planning: Proven ability to develop and execute project plans, budgets, and timelines while mitigating risks and ensuring alignment with organizational objectives
- Regulatory Compliance: Sound understanding of GMP requirements in the pharmaceutical industry, ensuring adherence to quality standards and compliance with guidelines
Certification
- Certified Project Management Professional (PMP), PMI - 2024
Academic Research Experience
McGill University, Canada (2021)
• Developed an adenovirus-vectored recombinant vaccine for Newcastle Disease Virus (NDV).
• Optimized strategies for improving yield of vaccine using Design-of-Experiments (DoE) and multivariate analysis, with shake flasks and bench-scale bioreactors in culturing HEK-293 cells and performed harvest, clarification and ultracentrifugation.
• Performed ddPCR, gel electrophoresis, TCID-50 assays.
University of California Davis, United States (2017)
• Developed Molecular Dynamics simulations of lipid bilayers supported on silica surface with GROMACS, and utilized PDB database for proteins modeling.
National University of Singapore, Singapore (2011)
• Successfully developed a novel prodrug of Vitamin-E TPGS-Docetaxel-Herceptin conjugation for targeted delivery of docetaxel for breast cancer HER 2 overexpression.
Timeline
Engagement Manager (Pro Bono Consulting)
Impact Consulting
08.2023 - Current
Scientist (Contract)
Sanofi
03.2023 - 08.2023
Bioprocess Scientist
Membio
11.2021 - 03.2023
Process Engineer
PM Group
01.2018 - 02.2020
Process Engineer
Global Process Systems
08.2011 - 08.2013
Master of Engineering - Biological And Biomedical Engineering
McGill University
Master of Science - Chemical Engineering
University of California - Davis
Bachelor of Engineering - Chemical Engineering
National University of Singapore
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