Sadiyya Gillespie
Minotola,NJ
Summary
Lead Manufacturing Associate with 6 years in cell and gene therapy manufacturing, focusing on automated processing and aseptic manipulation. Led GMP cleanroom teams in Leukopak processing, PBMC isolation, and cryopreservation workflows. Operated automated systems, including Cytiva Sepax and Miltenyi CliniMACS Prodigy, alongside manual processing in Biological Safety Cabinets to ensure compliant, high-yield cell products.
Overview
13
13
years of professional experience
Work History
Lead Manufacturing Associate
Minaris Advanced Therapies
Philadelphia, Pennsylvania
04.2024 - Current
- Lead and train teams on daily cell and gene therapy manufacturing activities in critical environments, strictly adhering to batch instructions and cGMP regulations while maintaining flawless aseptic technique.
- Guide, coach, and mentor junior manufacturing associates on core floor operations, including media preparation, cell thawing, passaging, harvesting, and equipment setup to enhance overall operational efficiency.
- Manage equipment status tracking, calibration requirements, and sample lifecycles utilizing BMRAM and STARLIMS, ensuring 100% data integrity and right-first-time execution during QC testing.
- Author and review high-quality technical documentation utilizing Microsoft Word, including deviations, batch records, and SOPs, to maintain strict written compliance.
- Assist with interdisciplinary communication between Manufacturing, QA, and QC teams to resolve complex floor issues, coordinate workflows with supervisors, and optimize site time management.
- Engage actively in technical transfer initiatives by collaborating with cross-functional partners to ensure seamless process and knowledge exchange.
- Serve as the manufacturing Subject Matter Expert (SME) during CAPA walkthroughs and Root Cause Analysis (RCA), partnering with QA and the compliance team to resolve floor escalations, identify process gaps, and implement corrective actions.
- Assist with complex solutions and material preparation protocols, analyzing raw data to troubleshoot and resolve processing issues before they impact timelines.
Senior Manufacturing Associate
WuXi Advanced Therapies
Philadelphia, PA
01.2023 - 04.2024
- Manufactured and trained teams on complex Cell & Gene Therapy (CAR-T) processes, equipment configurations, and cleanroom setups in strict compliance with cGMP standards.
- Served as a Subject Matter Expert (SME) for manufacturing floor escalations, driving cross-functional collaboration to ensure right-first-time product execution.
- Identified and remediated cGMP compliance and regulatory gaps on the shop floor, significantly enhancing overall manufacturing quality and audit readiness.
- Supported formal investigations of process deviations and non-conforming events, collaborating with Quality Assurance to ensure timely resolution and compliance.
- Trained and mentored incoming technicians on standard operating procedures (SOPs) while authoring technical training documentation to standardize floor operations.
- Collected, recorded, and reviewed critical process data per Good Documentation Practices (GDP), actively identifying scientific trends to recommend actionable processing paths to internal stakeholders.
Manufacturing Associate III
WuXi Advanced Therapies
Philadelphia, PA
01.2022 - 01.2023
- Manufactured critical Cell & Gene Therapy and CAR-T products in strict accordance with cGMP standards while training team cohorts to consistently meet high production throughput goals.
- Supported complex technical transfer activities across multiple functional groups to ensure seamless, compliant operational readiness.
- Implemented a robust material organization and inventory control strategy for Platform manufacturing programs, significantly reducing line disruptions.
- Proactively identified, communicated, and resolved raw material discrepancies on the shop floor to maintain strict processing timelines.
- Authored technical training documentation as a Subject Matter Expert (SME) to streamline personnel onboarding and improve site-wide knowledge transfer.
- Contributed technical floor insights to core operational meetings with both internal site teams and external corporate stakeholders.
Manufacturing Associate II
WuXi Advanced Therapies
Philadelphia, PA
01.2021 - 01.2022
- Manufactured multiple complex Cell & Gene Therapy products under strict cGMP regulations, completing rigorous qualifications to become a certified on-the-floor trainer.
- Executed precise aseptic techniques in cleanroom environments, actively identifying and correcting unacceptable practices to ensure compliance and contamination control.
- Authored and revised GMP Batch Records and Standard Operating Procedures (SOPs) to incorporate process updates and maintain alignment with regulatory standards.
- Collaborated closely with Technical Operations (Tech-Ops) to analyze root causes of process deviations and non-conforming events, contributing to continuous quality control improvements.
- Developed a deep technical understanding of specialized manufacturing instrumentation, performing basic troubleshooting and equipment interventions to minimize process downtime.
Manufacturing Associate I
WuXi Advanced Therapies
Philadelphia, PA
01.2020 - 01.2021
- Executed precise aseptic techniques to manufacture Cell & Gene Therapy products, ensuring absolute compliance with regulatory requirements and cGMP cleanroom standards.
- Operated and maintained specialized manufacturing instrumentation, supporting process continuity and equipment uptime for critical therapy lines.
- Generated detailed material pick-lists for project planners to facilitate the timely receipt, staging, and preparation of raw materials prior to GMP processing.
Patient Safety Assistant
Jefferson Health
Stratford, NJ
09.2014 - 10.2020
- Provided and ensured quality patient care.
- Supported healthcare professionals in evaluating patients' mental and physical conditions, contributing to comprehensive care assessments.
- Observed therapeutic patients to ensure a secure, supportive environment while documenting behaviors for care planning.
- Facilitated timely transportation of patients and specimen samples for testing, enhancing workflow efficiency.
Substitute Residential Assistant
Twin Oaks
Mount Holly, NJ
01.2014 - 01.2016
- Trained peer leader supervising developmentally disabled adults in a group home setting, while improving the independence of each resident.
- Administered daily medication to support residents' health and wellness.
- Facilitated engaging activities to promote learning and personal growth for residents.
- Ensured sanitized and organized household environment for residents' well-being.
Education
Bachelor of Science - Biology
Saint Andrews University
Laurinburg, NC05-2014
Rutgers University
Camden, NJMentoring in Medicine Certificate -
Lehman College
The Bronx, NYSkills
- Aseptic technique
- GMP/GDP
- Microsoft Office
- Interdisciplinary communication
- Team collaboration
- Working in critical environments
- Time management
- STARLIMS operation
- BMRAM operation
Shadowing And Volunteer
- Dr. Gay, Hematology, 110, Philadelphia, PA
- Dr. Marhefka, Cardiology, 45, Philadelphia, PA
- Dr. Mark, Cardiology, 200, Haddon Heights, NJ, Camden, NJ
Timeline
Lead Manufacturing Associate
Minaris Advanced Therapies
04.2024 - Current
Senior Manufacturing Associate
WuXi Advanced Therapies
01.2023 - 04.2024
Manufacturing Associate III
WuXi Advanced Therapies
01.2022 - 01.2023
Manufacturing Associate II
WuXi Advanced Therapies
01.2021 - 01.2022
Manufacturing Associate I
WuXi Advanced Therapies
01.2020 - 01.2021
Patient Safety Assistant
Jefferson Health
09.2014 - 10.2020
Substitute Residential Assistant
Twin Oaks
01.2014 - 01.2016
Bachelor of Science - Biology
Saint Andrews University
Rutgers University
Mentoring in Medicine Certificate -
Lehman College