Overview
Work History
Education
Timeline
Generic

Shumaila Ahmed

Philadelphia,PA

Overview

5
5
years of professional experience

Work History

Biotechnology Partnership Specialist

Thermo Fisher Scientific
07.2024 - Current


  • Oversaw and optimized document management systems by digitizing master service agreements into SharePoint, ensuring streamlined access and compliance for cross-functional teams.
  • Facilitated seamless collaboration between PPD and Thermo Fisher teams post-award by aligning operational activities with partnership goals and ensuring adherence to agreed protocols.
  • Developed and maintained critical tracking systems, including non-billable codes and metrics, to monitor partnership performance and enhance operational efficiency.
  • Provided administrative and logistical support for governance meetings, including preparation of agendas, minutes, and follow-up actions to support strategic decision-making.
  • Ensured audit-readiness and compliance by managing high-priority documents and monitoring documentation standards for both internal and external stakeholders.
  • Prepared detailed executive briefs for the JP Morgan Conference, enabling senior leadership to effectively engage with clients and CRO partners during high-stakes meetings.

Associate Project Manager

Thermo Fisher Scientific
06.2023 - Current
  • Central liaison between CMOs and GSK, managing in-licensed and acquired mAbs and large molecule assets (Cobolimab, Camlipixant, and TLR8)
  • Author of shipping related deviations and CAPAs, conducting reviews of critical raw data and documents in Veeva Quality Systems
  • Direct AARs with couriers to proactively address manufacturing risks, while developing and delivering training materials to ensure team alignment with updated procedures
  • Mastered the creation of diverse project timelines on PSAP and Microsoft Project to ensure timely delivery of regulatory submissions and mitigate potential risks
  • Knowledge transfer lead of Third Party documents, supporting key drug development milestones such as clinical batch release and material code generation

Lab Data Associate

Thermo Fisher Scientific
09.2022 - 06.2023
  • Analyzed and verified data in batch records to maintain compliance and application with Strategic External Development (SED) SOPs
  • Established a CTD index tracker for cross-functional team utilization, enhancing document tracking in VQD and ensuring data verification efficiency
  • Subject matter expert on document management with regulatory filings and validation activities
  • Managed a DEI Career Advocacy Program to assign projects to ambitious Grade 7-9 workers to increase their visibility
  • Mentored a senior director on how to lead a diverse and inclusive team through Diverse Reverse Mentoring

Biologics Clinical Planning and Operations (BCPO) Co-op - Lean Six Sigma Yellow Belt Certified

Johnson & Johnson
01.2022 - 07.2022
  • Implemented Kaizen and Lean troubleshooting skills to create an interactive process flow diagram that decreased batch shipment waste and increased supply chain efficiency
  • Conducted root cause analyses and CAPAs with cross functional teams to assess the impact of shipment documentation errors and prevent future delays in batch production
  • Organized drug substance to drug product manufacturing with CD22 by successfully utilizing the single point of contact pfd - project was Yellow Belt Certified
  • Mastered navigating through SOPs, document management, and technical writing skills to validate clinical commitments with CMOs
  • Created and hosted a new program called the Insight Series for student workers to interact and network with higher level mentors

Biopharmaceutical Technology Co-op

GlaxoSmithKline
06.2021 - 12.2021
  • Established product quality and supported commercial GMP manufacturing of the eosinophilic asthma drug, Mepolizumab, by compiling, verifying, and trending process data
  • Devised an engineering run report to analyze mixing studies in large-scale bioreactors to improve cell culture growth
  • Authored technical reports and SOPs to qualify the use of a new working cell bank and extend the hold time and agitation speed for cell bag media
  • Resolved protocol deviations with Quality team members by conducting root cause analyses
  • Mastered the use of platforms including: IP21, Aspen, Veeva, Trackwise, WebStatistica, and ERP

Research Assistant

RWJ & Center of Advanced Biotechnology and Medicine
09.2019 - 05.2021
  • Study: The damage caused by antibiotics on the human microbiota can be restored from a healthy donor
  • Mastered RNA extraction with over 400 samples and trained two graduate students
  • Designed an experiment to test protein expression in the presence of Beta Lactam
  • Proven dissection skills developed in short span of time, actively participated in weekly dissections
  • Advanced skills in RT-qPCR shown by continuous successful amplification curves with no errors
  • Strong quantitative data analysis skills, easily interpreting CT values and converting them into graphics on Prism

Education

Master's of Business Science - Drug Discovery & Development

Rutgers University
New Brunswick, NJ
12.2023

Bachelor of Science - Biotechnology

Rutgers University
New Brunswick, NJ
05.2021

Timeline

Biotechnology Partnership Specialist

Thermo Fisher Scientific
07.2024 - Current

Associate Project Manager

Thermo Fisher Scientific
06.2023 - Current

Lab Data Associate

Thermo Fisher Scientific
09.2022 - 06.2023

Biologics Clinical Planning and Operations (BCPO) Co-op - Lean Six Sigma Yellow Belt Certified

Johnson & Johnson
01.2022 - 07.2022

Biopharmaceutical Technology Co-op

GlaxoSmithKline
06.2021 - 12.2021

Research Assistant

RWJ & Center of Advanced Biotechnology and Medicine
09.2019 - 05.2021

Master's of Business Science - Drug Discovery & Development

Rutgers University

Bachelor of Science - Biotechnology

Rutgers University

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Shumaila Ahmed