Kailash Singh, Phd-Mba Email and Phone Number

At Devote Consulting, I successfully led initiatives that enhanced regulatory compliance for top-tier biotech clients. Key accomplishments include securing FDA 510(k) approval for a Class C Software as a Medical Device (SaMD) by developing and streamlining over 10 critical design history file documents, including Software Development Plans and System Requirements Specifications.I conducted regulatory gap analyses for Quality Management Systems (QMS), identifying and addressing compliance gaps to meet ISO-13485 and 21 CFR Part 820 standards. Through hazard-based risk assessments, I improved risk identification accuracy by 40%.My organizational change management workshops increased compliance awareness across teams by 30%, and weekly cross-functional meetings ensured 95% on-time delivery of project milestones. My work directly contributed to reducing compliance-related delays by 25%.

At LEO Pharma, I contributed to strategic procurement by streamlining the RFI/RFP process for CDMO selection, reducing timelines by 66%. Supporting a $11 billion biologics initiative, I conducted detailed market analysis and evaluated proposals from eight shortlisted CDMOs to aid executive decision-making.I collaborated with cross-functional teams, aligning procurement goals with drug discovery needs. My ability to synthesize complex data into actionable insights helped drive informed decisions, ensuring seamless progress for a pivotal bispecific antibody manufacturing project.Key contributions included developing a robust procurement strategy, facilitating meetings, and presenting insights to stakeholders, significantly improving project efficiency and resource allocation.

As Project Manager, I led the establishment of a $3M diagnostic lab equipped with cutting-edge SIMOA and OLINK technologies, delivering the project 2 months ahead of the 12-month timeline. This lab enabled the launch of ELISA kits that reduced diagnostic turnaround times by 50%.I identified target market segments, boosting diagnostic sales leads by 40% through a targeted go-to-market strategy. My risk management initiatives mitigated potential delays, achieving a 90% adherence rate to planned schedules and budgets.

• Successfully raised 4 million HKD in funds through fundraising and VC events, playing a key role in securing capital for a research and pre-clinical development company.• Developed strategic fundraising plans, including identifying and targeting key investors, creating compelling pitch decks and presentations, and networking with relevant stakeholders.• Led a team of PhDs conducting pre-clinical studies for novel compounds, utilizing strong leadership and management skills to guide the team towards successful outcomes.• Managed project timelines, budgets, and resources coordinating with cross-functional teams to ensure project goals were met and delivered within agreed-upon parameters.• Conducted comprehensive market research, including identifying market trends, and analyzing competitive landscapes, to inform strategic decision-making and provide stakeholders with the most up-to-date insights and data.• Developed and implemented project management tools and techniques to streamline project management processes, including project plans, schedules, budgets, and risk management plans.• Collaborated with key stakeholders, including scientific researchers, external vendors, and investors, to ensure seamless project delivery and successful outcomes.• Created and managed project documentation, including progress reports, presentations, and other materials, to keep stakeholders informed and engaged.• Monitored and reported on project metrics, including project status, budget, risks, and opportunities, providing timely and accurate information to project sponsors and other key stakeholders.• Fostered a culture of excellence, collaboration, and transparency, driving engagement and teamwork across cross-functional teams and promoting successful project outcomes.

• Fostered relationships and collaborations between renowned scientists from HK, US, France, and Israel, building strong partnerships and networks to facilitate scientific research and development.• Generated novel industry-focused research projects, leveraging extensive subject matter expertise to identify areas of potential growth and opportunity.• Contributed to the development of a patented anti-hypertensive molecule, playing a key role in the creation of a new therapeutic option for patients with hypertension.• Published 22 research articles in reputed international journals, including the European Journal of Medicinal Chemistry, and achieved an H-index of 10, demonstrating a strong track record of academic and scientific success.• Conducted comprehensive market research, including identifying market trends, and analyzing competitive landscapes, to inform strategic decision-making and provide stakeholders with the most up-to-date insights and data.• Managed project timelines, budgets, and resources coordinating with cross-functional teams to ensure project goals were met and delivered within agreed-upon parameters.• Developed and implemented project management tools and techniques to streamline project management processes, including project plans, schedules, budgets, and risk management plans.• Collaborated with key stakeholders, including clinical researchers, external vendors, and investors, to ensure seamless project delivery and successful outcomes.• Created and managed project documentation, including progress reports, presentations, and other materials, to keep stakeholders informed and engaged.• Monitored and reported on project metrics, including project status, budget, risks, and opportunities, providing timely and accurate information to project sponsors and other key stakeholders.

• Fostered a culture of excellence, collaboration, and transparency, driving engagement and teamwork across cross-functional teams and promoting successful project outcomes.• Created and managed project documentation, including progress reports, presentations, and other materials, to keep stakeholders informed and engaged.• Monitored and reported on project metrics, including project status, budget, risks, and opportunities, providing timely and accurate information to project sponsors and other key stakeholders.• Fostered a culture of excellence, collaboration, and transparency, driving engagement and teamwork across cross-functional teams and promoting successful project outcomes.

I have authored 22 research articles in reputed international journals, including the European Journal of Medicinal Chemistry, and an H-index of 10. List available on Google Scholar https://scholar.google.com/citations?user=bd4ko2AAAAAJ&hl=en

Ranked as excellent by studentsLab Courses-• Molecular Biology; Micro Biology Lab Course; Biotechnology Lab Course Taught-• Theories, Hands-on techniques, and Scientific writing.• Graded writing assignments, • Assisted course development

Double Helix is a pathology laboratory with 20 active members. Double Helix’s scientific team is constantly abreast with the new advancements in reproductive immunology.• Team player: Supported the team of immunohistochemistry and pathologists in cell line maintenance and daily operations. • Client-facing skills: Interacted with clients and in B2C setup explaining the company offerings and products. Also, trained as a customer-care executive by Vodaphone limited as an undergraduate.

Vodafone India (formerly Vodafone Essar Ltd, Huchison Essar Ltd) was the Indian subsidiary of UK-based Vodafone Group plc and was a provider of telecommunications services in India.Worked in a team environment in customer engagement and sales team.Managed new customer service and field team for product delivery. Troubleshot the backend issues of customer demands and documentation issues managing the infield support.