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Business Management Consultant

Syngene International Limited

Crisis Management Operation Lead-Pandemic (Biocon Group of Companies)

Handled program management for risk and safety operations, managed cross-functional teams, and supported business development (grants, contracts). Led alliance management and ensured compliance during FDA, GLP, and GCP audits. Contributed to strategic planning, delivery optimization, and enterprise risk management.

AGM Workplace wellbeing Operation management & Strategy Support 

Freelance Service Provider

Developed and executed business strategies for the energy and food sectors, aligning private equity investments with market needs and regulatory requirements. Led strategic alliances and collaborations, fostering high-value partnerships to drive growth. Implemented Key Account Management (KAM) frameworks, ensuring customer-centric solutions and long-term value creation. Conducted market analysis, aligning investment strategies with client objectives while balancing profitability, risk management, and ethical business practices to drive sustainable growth

Business Strategy Consultant

George Washington University

Managed R&D and research programs, ensuring compliance and quality for the Human Subject Protection Program. Oversaw protocols, operational management, and regulatory adherence across lab design, biosecurity, and animal research.

Lab Safety Director

University of Virginia

Supported R&D in life sciences, aligning operational protocols with research needs. Managed facility compliance, critical contracts, and advanced imaging programs. Led cross-functional training, leveraging expertise in regulatory compliance, operational efficiency, and project management.

Research and Development Project Manager

Frost & Sullivan

Directed market research and strategic analysis for pharmaceuticals, focusing on new entities, cytotoxic substances, and diagnostics. Developed business strategies and operations insights, aiding companies in navigating industry complexities.

University of Guelph

Led research on ProP's role in E. coli as an osmosensor, studying its impact on cellular adaptation and environmental response. Provided critical insights into protein function and membrane localization

Postdoctoral Research Fellow

University of Strathclyde

Screened MRSA strains and developed a bacterial phage detection system, ensuring product efficacy through meticulous research.

Doctoral Research Assistant

Led comprehensive study on Streptomycetes, focusing on growth, protein management, and cellular division; engineered genetic approaches.

Doctoral Fellow

Dr. Vinod Jyothikumar, Results-driven operations leader with a proven track record of transformative growth and setting new standards of excellence. Expertise includes C-suite management, alliance governance, and client relationship management within global life sciences, biotechnology, pharmaceuticals, agrochemical, and chemical business environments.  Specialist in GxP, CRAMS, digital manufacturing, SMART factories, Industry 4.0, and ESG investing, consistently delivering impactful solutions, boosting profitability, and increasing customer satisfaction.  Strong Key Account Management skills, cultivating and expanding relationships with strategic clients.  Develops and implements Go-To-Market strategies that drive market penetration and revenue growth.  Strategic acumen, business development expertise, and effective communication enable translation of complex concepts into actionable strategies.  Passionate about fostering collaboration and driving projects to success, committed to sustainable and ethical practices.

Dr. Vinod Jyothikumar

Biocon Biologics

Presently I have been assigned the role of "IT Lead & Digital Business Partner for Biologics Manufacturing" @Biocon Biologics. Reporting to Global VP, IT.

Being the Single window for all Technology and Digital needs of entire manufacturing sites globally, I am responsible to liaise effectively between the Manufactuing and IT divisions to establish Digtal/IT road map, IT solutioning business cases, present the best case to Executive leadership and obtain sponsorships, select suitable product/solution & Vendor partner, Constitute the project teams, deliver/implement/rollout the product/solution, facilitate the adoption, lead the end-user support and C-SAT scoring, monitor the product evolution, Front-end the FDA Inspections and drive the ROI continually.  

At present I have team of Product Manager(s), Project Manager(s), Business Analys(s), AMS services Leads/teams reporting directly to me in addition to many corss functional employees working with me in close collaboration. 

Current projects include, Werum's/Koerber's PAS-X MES, PAS-X Savvy, Honeywell's eLOG (MES), ValGenesis's VLMS, SAP - Plant Maintenance, etc.

My Gallup Clifton strength Profile - CONNECTEDNESS | STRATEGIC | COMMUNICATION | INCLUDER | BELIEF

Associate Director - IT Lead and Digital Business Partner for Biologics Manufacturing

Responsible to meet the end to end Digital/IT needs of Manufacturing division. 
1. Establish and manage the digital roadmap and IT Maturity journey 
2. Drive 100% electronic documentation to enable data analytics (MES, eLOG, VLMS, eCSV)
3. Implementing advanced Technology solutions to enhance Quality & Compliance 
4. Continually improving user experience
5. Program Lead for MES PAS-X global implementation
6. Manage the Vendors and their SLAs
7. Manage the AMS teams
8. Manage the Product Management, Project Management and Business Analyst teams

IT Business Partner for Biologics Manufacturing 

Product Manager and Project Management-VLMS & eCSV

Senior Manager (Digital Transformation)

Manager, Life Sciences Digital Innovation & Digital Transformation 

Freelancing consultant

Cenduit

Heading QA department for APAC region. Reporting into VP, Quality at US. 

1. Responsible for managing and continually improving the Quality Management Systems. QA and Regulatory compliance assurance with reference to global regulatory bodies such as USFDA, EU, MHRA, ICH GxP and associated Pharma drug life cycle industry guidance and expectations  standards. 
2. Responsible for hiring, orienting, training, managing the QA employees
3. Active role in defining Quality objectives globally
4.Key leader in defining Key Performance Indicators (KPIs)
5.Responsible for product, business and operational data measurement, monitoring, analysis and improvisation followed by regular effectiveness check and evaluation
6.Review and approve the assessments on 21 CFR Part 11 compliance. 
7.Provide guidance and direction to employees on Quality and Regulatory matters related to Software Development life cycle, Validation, Audit trials, Inspections etc.
8.Global CAPA management | Deviation Management |  Vendor Management | Employee training

Senior ITQA Manager

Avesthagen

Establish new Pharma QA workforce in support of new Manufacturing set up in collaboration with Cipla, Goa unit. Reported into Global Head of Quality and Regulatory

1. Responsible to recruit, orient, train QMS and Microbiology QC staff. Performance management
2. Support in drug licence filings
3. Member secretary of many Independent review boards.
4. SOP revision and approvals.
5. CSV Equipment Qualification

Assistant Manager - GxP Quality Assurance and Regulatory affairs

Biocon

QMS Documentation: Drug life cycle Validation master plan, SOP preparation, training, BMR, CAPA, Deviation, Process validation, cleaning validation, Equipment qualification, Internal auditing, hosting sponsor audits, supporting FDA regulatory inspection etc.

Executive - cGMP compliance

Drug manufacture through microbial large scale fermentation and purification processes(API). GMP and FDA compliance.

Executive- Manufacturing

Manufacturing Industrial Enzymes and Pharmaceutical drugs through Microbial Fermentation (both solid and liquid state) and downstream purification processes.

Junior Executive-Manufacturing

I'm a seasoned Life Sciences professional of Empathetic Leadership style with over 25 years of Industry Experience. Hands on Experience in Manufacturing, Quality Assurance, Computer System Validation, SDLC and IT/Digital Transformation.  

Presently I have been assigned the role of "IT Lead & Digital Business Partner for Biologics Manufacturing" @Biocon Biologics. 

Being the Single window for all Technology and Digital needs of entire manufacturing sites globally, I am responsible to liaise effectively between the Manufactuing and IT divisions to Define the Digital roadmap, establish IT solutioning business cases, present the best case to Executive leadership and obtain sponsorships, select suitable product/solution & Vendor partner, Constitute the project teams, deliver/implement/rollout the product/solution, facilitate the adoption, lead the end-user support and C-SAT scoring, monitor the product evolution, Front-end the FDA Inspections and drive the ROI continually.  

At present I have team of Product Manager(s), Project Manager(s), Business Analyst(s), AMS services Leads/teams reporting directly to me in addition to many corss functional employees working with me in close collaboration. 

Current projects include, Werum's/Koerber's PAS-X MES, PAS-X Savvy, Honeywell's eLOG (MES), ValGenesis's VLMS, SAP - Plant Maintenance, etc.

My Gallup Clifton strength Profile - CONNECTEDNESS | STRATEGIC | COMMUNICATION | INCLUDER | BELIEF

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The Battle

Dr. Vinod Jyothikumar

VENU (Venugopal S)

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