Hetal Patel

Provided oversight in strategic planning and execution on early stage microbial programs while ensuring alignment with the overall company strategy.

• Managed high profile portfolios worth over 15 million in scope of work.
• Partner with the Program Team Lead to develop, build, gain approval and execute on complex programs.
• Lead and drive collaboration within program teams and key cross functional leaders to meet expected timelines, budget and safety standards.
• Help manage team interactions to ensure input from appropriate team members is obtained to promote informed decision making.
• Collaborate with key stakeholder to prepare presentations for executive and functional leaders and teams.
• Work as part of a centralized Project Management function, contributing to cross departmental collaboration and continuous process improvement
• Interacted with customers and clients to identify business needs and requirements.
• Coached team members on productivity strategies to accomplish challenging goals.
• Established milestones and objectives based on input from functional areas and stakeholders.
• Identified program obstacles and communicated possible impacts to team.
• Managed multiple strategic projects with numerous sub-projects or workstreams.
• Participated in pilot tests and revised programs based on feedback and results.
• Provided program management expertise in lean Six Sigma strategies and agile methods, practices and execution.

• Drafts technical scope, high level timelines, and price estimates for the bid proposal using current quoting processes, tools, and templates.
  
• Reviews technical strategy or alternative solutions with subject matter experts (SMEs) to align with client needs.
• Issues new proposals and revisions of varying degree of difficulty then ensures completion of the bid process in a timely manner.
  
• Engaged with the Legal and Contract functional groups implement legal terms and conditions. •
• Supports Sales team on teleconferences or site visits with the client to confirm the technical aspects of projects are understood and priced appropriately.
  
• Maintains the Salesforce platform to continuously update senior leadership.
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Utilized strong project and process knowledge to drive and deliver on project milestones while performing continuous improvement activities for the introduction and execution of clinical trials and commercial therapeutics.

• Developed and initiated projects, managed costs, and monitored performance.
• Led and provided strategic direction to the Drug Product Readiness Governance Team of 15+ cross functional leaders to perform risk analysis in order to mitigate and improve processes to meet expected project deliverables and milestones across production.
• Monitored project performance to identify areas of improvement and make adjustments.

Managed 12 assigned project scopes, functional group deliverables, and budgets to deliver development and early to late phase sterile medicinal products.
Identified, authored, and managed changes of scope to meet or exceed project stakeholder expectations. • Met right – first – time and on – time delivery by supporting cross – functional activities. • As the primary point of contact, identified paint points and accurately communicated weekly status reports and quarterly lessons learned to internal and external stakeholders.
• Facilitated decision making, escalations, conflict management, and cross – functional collaboration to drive progress to project completion.
• Identified and developed risk mitigation strategies to comply with Good Manufacturing Practices and Standard Operating Procedures for development, clinical, and commercial biopharmaceuticals.
• Supported other activities as dictated by the needs of the department and the business and was prepared to support travel as required based on project requirements.
• Established logistic training standards for development products.
• Designed organizational communication gap assessments during manufacturing activities and project initiation process improvements for onboarding and retention.

• Supported multiple projects in a cross functional and global environment.
• Acted as a liaison between project manager and internal teams.
• Initiated, planed, executed, monitored and coordinated clinical trial material (CTM) sample shipment to third party vendors.
• Helped develop job aids and training for various software.
• Successfully managed projects with full life cycle responsibilities while developing project timelines and templates for team Steering Committees and for new technologies.

• Performed Quality Control Testing on final, intermediate, and stability of products.
• Applied knowledge and skills to diverse laboratory analyses.
• Performed cGLP practices according to current compendia, regulatory and corporate quality systems and principles.
• Performed investigations, validations OOS/STR and Drug Profiling via Dissolution.

• Organized, coordinated, and supervised high volumes of work while adhering to excellent quality and firm timelines related to the clean room and laboratory studies and projects.
• Performed chemical and microbiological assays using various methods.
• Tracked Exception Reports, CAPAs and Non Conforming Materials with responsibility for timely documentation, resolution and closure of reports.
• Trended, prepared and presented monthly reports to visually demonstrate the state of the facility during management review presentations.

• Worked with highly recognized laboratories within the department of Pharmacology, Physiology, and Environmental Health Sciences.
• Dedicated to studying the effects Perfluorooctanoic acid (PFOA), used heavily in Industry, on development of humans; the effects of Diabetes on Cardiac tissues during Ischemic events in humans; the effects of byproduct of pharmaceutics in the environment to the developmental aspects of children.
• Demonstrated skills in designing, directing, optimization, instrument calibration, training Students, and executing projects.
• Developed skill set, technical assays, Roadmap, and oversaw project tracking.
• Took a lead role in numerous projects and consistently exceeded Supervisor’s expectations.