Summary
Overview
Work History
Education
Skills
Certification
Volunteer Experience
Timeline
Generic

John Ross

Summary

Dedicated professional with 6+ years in biopharmaceuticals and healthcare administration. Specialized in project management, data visualization, process optimization, and regulatory compliance. Skilled in cross-functional collaboration, problem-solving, and continuous improvement. Adaptable, with a strong ability to acquire and apply new knowledge in dynamic environments.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Supply Planning, Reporting, and Compliance

Regeneron Pharmaceuticals, Inc.
Rensselaer
02.2023 - Current
  • Collaborate with cross-functional teams to plan materials required by programs
  • Identify potential supply risks and constraints across program networks, and guide alignment with internal/external manufacturing teams to develop production plans
  • Oversee forecasting and demand intake activities (clinical, commercial, and independent demand), and optimize Supply Chain planning in compliance with FDA regulations and current GMP (e.g., implemented new process for document control issuance, printing, and reconciliation; biological product manufacture reporting)
  • Develop joint improvement initiatives and performance standards for advanced planning system (RapidResponse) integration analytics, production sequence concepts, optimized production schedules, and efficient resource utilization
  • Participated in data stewardship program during implementation of new APS program handling, operational maintenance, and data check requests throughout the department
  • Led document assurance and reconciliation processes, ensuring full compliance with established practices, procedures, and regulatory requirements for both clinical and commercial products

Compliance and Fill Finish

Regeneron Pharmaceuticals, Inc.
Rensselaer
06.2020 - 02.2023
  • Created database housing qualification, evaluation, and training kits for Quality Assurance (QA) and manufacturing operators
  • Coordinated facilitator activity during the evaluation and qualification of visual inspectors (VI) and qualification kits
  • Collaborated with QA and Manufacturing to create vial training and qualification kits for VI operators, and developed suite of data analytics tools to conduct unit Point of Detection tracking and evaluate operator performance
  • Revised standard operating procedures (SOPs) for qualification kit creation, maintenance, and qualification of VI operators in accordance with current GMP
  • Managed risk identification and mitigation activities for Quality Risk Management (QRM), and developed data analytics tools for project monitoring, workload forecasts, risk assessment performance tracking, workflow scheduling, and ad hoc requests
  • Prepared documentation for subject matter experts during internal audits for inspection readiness, and served as department liaison for continuous improvement initiatives with Medical Device, QRM, and QA
  • Organized quarterly risk register including relevant CAPAs to convey overall risk status and mitigation efforts, including identifying potential risks, establishing safeguards, and assessing post-implementation measures
  • Facilitated use of risk assessment tools [e.g., Failure Mode and Effects Analysis] evaluating safety and quality for Preclinical Manufacturing and Process Development
  • Processed QRM engagement worksheets for change controls, and provided guidance to risk assessment owners regarding QRM tools, policies, and procedures

Quality Assurance Consultant

The Eclectic Global Consulting Group
Albany
09.2019 - 06.2020
  • Created workload tracking tool for drug product quality and QRM that monitored project progress and provided data analytics for risk assessments and their facilitators
  • This tool allowed for the critical tracking of Key Performance Indicators, metrics, and other data points, supporting business intelligence, project management, and continuous improvement efforts
  • Provided administrative support to QA Directors and the VP of Operations (i.e., coordinated meetings for high-level change control updates, managed document revisions in compliance with regulatory requirements)
  • Facilitated QA process improvement initiatives in alignment with general management directives
  • Supported Quality Council comprised of relevant departments providing cross-functional input to evaluate deviations and impact on product quality

Development Officer

Albany College of Pharmacy and Health Sciences
Albany
09.2010 - 10.2018
  • Collaborated with industry and community pharmacists, population health and public health professionals in the management of business development projects, activities for research and promotion for service modules assisting point of care screening, assessments, patient education, referral, and navigation services for a health facility cooperative and two pharmacies
  • Provided comprehensive administrative support to senior leadership (i.e., scheduled meetings, managed complex calendars, prepared reports/presentations, coordinated travel arrangements, ensured seamless communication across departments)
  • Participated in research and community health education projects in a center for coordinated clinical care which achieved a $6.1M fundraising goal (asthma and diabetes-focused)
  • Coordinated and developed fundraising initiatives for the health center which provided multiple patient resources (e.g., health screenings, patient wellness and education, physical exams)
  • Shaped partnerships with healthcare alumni improving the ability of the college pharmacy and health clinic to adapt and meet the health needs of the community
  • This served forty-eight faculty public health practitioners and 18,000 patients

Education

Master of Healthcare Administration -

Utica University

Bachelor of Arts -

SUNY Oneonta

Skills

  • Project Management
  • Community Healthcare
  • Detailed reporting
  • Agenda development
  • Continuous improvement processes
  • Teamwork and collaboration
  • Operations coordination
  • Spreadsheet organization
  • APS Integrations
  • Microsoft 365
  • Power BI
  • Python
  • Qlik Sense
  • QUMAS EDMS
  • RapidResponse
  • SharePoint
  • SQL
  • Tableau
  • VBA

Certification

Data Science with SQL and Tableau Certificate, Cornell University

Volunteer Experience

AFYA Foundation

Timeline

Supply Planning, Reporting, and Compliance

Regeneron Pharmaceuticals, Inc.
02.2023 - Current

Compliance and Fill Finish

Regeneron Pharmaceuticals, Inc.
06.2020 - 02.2023

Quality Assurance Consultant

The Eclectic Global Consulting Group
09.2019 - 06.2020

Development Officer

Albany College of Pharmacy and Health Sciences
09.2010 - 10.2018

Master of Healthcare Administration -

Utica University

Bachelor of Arts -

SUNY Oneonta
John Ross