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Kerri Staruk

@kerristaruk

Cell therapy training specialist focused on aseptic technique, cGMP compliance, and coaching teams to deliver safe, high-quality manufacturing.

United States

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What I'm looking for

I’m looking to strengthen patient-first cell therapy manufacturing by leading aseptic training, audits, and documentation, and by using CAPAs and data-driven improvements to partner effectively across departments under cGMP expectations.

I’m a Senior Training Specialist, Cell Therapy at Lonza Biologics, where I provide hands-on training in ISO 5 and 7 environments. I administer aseptic behavior and gowning certification, perform aseptic audits, and support gowning/aseptic qualification administrative responsibilities while partnering cross-departmentally to close any lapses. I also initiate deviations, own CAPAs, and update documentation to maintain cGMP compliance with a safety-first, patient-first mindset.

Previously, as a Manufacturing Operations Senior Associate at Vertex Pharmaceuticals, I performed clinical product manufacturing of hESCs according to cGMP standards. I managed GMP cell processing operations for adherent and suspension cell cultures using 6-well plates, T-flasks, CellStacks, and PBS-3 Vertical Wheel Bioreactors. I qualified as a trainer, participated in triages and CAPA investigations, and identified process optimization opportunities.

Before that, I served as a Cell Therapy Manufacturing Associate, Level 2 at Lonza Biologics, where I strengthened aseptic technique for open and closed viral and non-viral therapies. I contributed to tech transfers, cross-trained across QC/EM (LIMS), QA, validation, inventory management (SAP and Syncade), and deviation investigation (Trackwise), and I completed first-level review of batch records, SOPs, work instructions, and logbooks for completeness and accuracy. Earlier in my career, I worked as an Emergency Veterinary Technician and Lead Veterinary Technician (CVT, LVT), supervising 10+ direct reports and authoring and updating SOPs for accreditation, which sharpened my technical writing, training, and communication.

Experience

Work history, roles, and key accomplishments

Current

Senior Training Specialist

Current

Lonza Biologics

Dec 2024 - Present (1 year 6 months)

Hands-on trainer for aseptic behavior and techniques in ISO 5 and ISO 7 environments, including gowning and aseptic behavior certification for personnel entering manufacturing. Conducts aseptic audits, supports deviation/CAPA work, maintains documentation alignment with global procedures and federal regulations, and delivers aseptic theory content for FDA response post-PAI.

Aseptic Technique Aseptic Audits Gowning Qualification CGMP Compliance Deviations And CAPA Documentation Control MS Office FDA Response Support

Manufacturing Ops Senior Assoc

Vertex Pharmaceuticals

Mar 2024 - Nov 2024 (8 months)

Performed clinical product manufacturing of hESCs according to cGMP standards, supporting GMP cell processing for adherent and suspension cell cultures. Qualified and trained employees, participated in triages and CAPA investigations, and collaborated cross-functionally to maintain cGMP compliance and identify process optimization opportunities.

HESC Processing Cell Culture (Adherent)CellStacks PBS 3 Vertical Wheel Bioreactors CAPA GMP Documentation Process Optimization Training

Cell Therapy Manufacturing L2

Lonza Biologics

Sep 2021 - Mar 2024 (2 years 6 months)

Executed aseptic technique for open and closed viral and non-viral cell and gene therapy manufacturing, and supported tech transfers with MSAT, QC, QA, and EHS. Served as a trainer and shift lead, handled cryopreservation and shipment to clinical sites, and performed documentation review/approval to maintain cGMP compliance across cross-trained functions.

Aseptic Technique Viral Non Viral Therapies SAP And Syncade Inventory

Emergency Veterinary Technician

Rockingham Emergency Veterinary Hospital

Jul 2020 - Aug 2021 (1 year 1 month)

Provided inpatient and outpatient emergency veterinary care, including triage, client communication and education, diagnostics, treatments, discharging, and invoice creation. Used advanced technical skills such as venipuncture, surgical preparation and assistance, and anesthesia induction/maintenance.

Emergency Veterinary Care Triage Client Communication Diagnostics Venipuncture Anesthesia Induction Maintenance Treatment Planning

Lead Veterinary Technician

Canobie Lake Veterinary Hospital

May 2008 - Aug 2020 (12 years 3 months)

Managed inventory and supervised 10+ direct reports, including a summer intern program. Prepared the hospital for AAHA re-accreditation by managing staff training and authoring/updating SOPs, and coordinated external laboratory testing and vendor-based purchasing/inventory planning.

Veterinary Technician Leadership Inventory Management Team Supervision AAHA Accreditation Prep SOP Development Vendor Management Anesthesia And Diagnostics