Summary
Overview
Work History
Education
Skills
References
Timeline
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Nancy Napolillo

Warwick,RI

Summary

Adept at leading cross-functional teams and driving process improvements, my tenure at AbbVie showcased my ability to enhance operational efficiency and mentor personnel effectively. Leveraging in-depth knowledge of Biotech cGMP regulations and a strong foundation in quality management systems, I excel in high-pressure environments, ensuring compliance and advancing manufacturing excellence.

Overview

19
19
years of professional experience

Work History

Superintendent of Production

AbbVie
Worcester, MA
08.2024 - Current
  • Oversee manufacturing processes to determine areas needing improvement or optimization.
  • Provided technical guidance in resolving process-related problems.
  • Monitored daily production operations to ensure compliance with established policies and procedures.
  • Guided area supervisors to enhance their management skills.
  • Conducted regular inspections of production facilities to identify potential issues or hazards.
  • Set and communicated ambitious production goals to all personnel and conveyed problems or obstacles to senior management.

Operations and Quality Assurance Supervisor

Moderna
Norwood, MA
01.2021 - 03.2024
  • Quality Assurance Supervisor - Supervised a team of twelve Quality Assurance Specialists. Provided daily guidance to staff on best practices in quality assurance methods. Ensured clear, compliant, and accurate documentation of SOPs, protocols, and closure of digital and paper batch records using Veeva and Infobatch quality systems for timely disposition of products. Led and attended daily tier meetings, and cross-functional meetings for the disposition of batches. Supported regulatory inspections and led continuous improvement activities by implementing on-the-floor reviews and guidance. Provided QA support for change controls, processes, and OOS investigations, and associated CAPAs.
  • Manufacturing Operations Supervisor - Interviewed and onboarded a team of eight operators to twenty operators in six months. Developed, mentored, and trained a strong, cohesive team responsible for producing mRNA-based medicines in an extremely fast-paced cleanroom environment. Created a mentoring program, trained the trainer, conducted safety talks, implemented end-of-shift checklists, provided guidance signage in cleanrooms, ensured audit readiness for new employees in the industry, held one-on-one meetings, and developed breakout focus groups. Daily walk-throughs and team support of four continuous manufacturing areas.

Sr. Bioprocess Engineer

Avexis
Libertyville, IL & Durham, NC
07.2018 - 12.2020
  • Provided on-the-floor leadership for upstream and downstream manufacturing process operations, including set-up, use, and process of single-use process materials for TFF, chromatography, and iCellis bioreactor systems in Libertyville, Illinois.
  • Supported the Process Development team in San Diego, CA.
  • Oversaw contract teams for manufacturing cGMP mRNA medicines for clinical trials at BioPark in Baltimore, MD.
  • Training lead and on-the-floor point person for downstream commercial operations with an external contract manufacturing organization in Baltimore, MD.
  • Training operations lead for upstream and downstream start-up operations in Durham, NC.
  • Led the team on how to document and troubleshoot all engineering activities according to established procedures.
  • Led walk-downs and Factory Acceptance Testing of new equipment in Strasbourg, France.
  • Participated in new product introduction, technology transfer, and experiment design.
  • Evaluated existing processes and technology solutions for improvement opportunities.
  • Advised management on best practices for improving engineering operations.
  • Collaborated with cross-functional teams throughout the development process to ensure successful outcomes.

Manufacturing Associate I-IV

Alexion
Smithfield, RI
06.2006 - 12.2017
  • Represented large-scale downstream manufacturing as team lead in cross-functional initiatives during start-up campaigns.
  • Daily collaboration with support groups (Quality Assurance, Quality Control, Validation, MS&T, and logistics) to maintain the production schedule.
  • Directed the team for large-scale column packing and qualification activities.
  • Upheld company standards while meeting tight deadlines.
  • Trained new employees on production processes and procedures.
  • Authored, revised, and reviewed SOPs, and MBRs.
  • Lead downstream support during FDA, EMA, and internal compliance audits.
  • Executed IQ, OQ, and PQ of equipment for the start-up campaign.
  • Active member of the Emergency Response Team, on-boarding trainer for EH&S policies and procedures.
  • Routinely performed large-scale TFF systems, viral filtration, bioburden reduction, and chromatography, including Protein A and Q Sepharose I and II, utilizing Unicorn Operating Systems.

Education

Bachelor of Science - Clinical Laboratory Science

University of Rhode Island
Kingston, RI
05-2010

Skills

  • Cross-Functional Team Leader
  • Personnel Management
  • Training and mentoring
  • Regulatory inspections
  • Technical Writing and Review
  • Strong quality support for on-the-floor manufacturing
  • Proficient in Audit Readiness
  • Safety Standards Compliance
  • Expertise in Biotech cGMP Regulations
  • Event Investigation Leadership
  • Public speaking and presentations
  • Flexible schedule
  • Strong Team Collaboration
  • Quality Management Expertise
  • Adaptable in Fast-Paced Environments
  • Experienced in Identifying Compliance Risks

References

References available upon request.

Timeline

Superintendent of Production

AbbVie
08.2024 - Current

Operations and Quality Assurance Supervisor

Moderna
01.2021 - 03.2024

Sr. Bioprocess Engineer

Avexis
07.2018 - 12.2020

Manufacturing Associate I-IV

Alexion
06.2006 - 12.2017

Bachelor of Science - Clinical Laboratory Science

University of Rhode Island

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