Tasha Holsey

Cell therapy manufacturing specialist with nearly 3 years of hands-on cGMP experience producing autologous cell products for rare genetic disease and cancer treatment. Authored deviation investigations, OOS reports and CAPAs alongside Quality, and wrote and revised SOPs, batch records and validation documents supporting clinical-to-commercial development (BLA filings). Earned a Master of Legal Studies in Healthcare Compliance (Drexel, 2021), then used 2021 to present to complete advanced clinical graduate training and build a licensed, state-regulated practice that runs on written procedures, sanitation discipline and accurate records.

Ready to return full time to biopharma quality, deviation management, QC, or compliance and regulatory affairs.

Cell Therapy Manufacturing Specialist at Adaptimmune (2020-03 – 2021-04)

• Authored out of specification (OOS) reports, deviation investigations and corrective and preventive actions (CAPA) with the Quality team.
• Identified real-time manufacturing deviations and atypical results and escalated them promptly to the Manufacturing Manager and Quality.
• Performed aseptic cGMP manufacturing of autologous patient cell products in cleanroom attire, handling human blood and blood-derived intermediates.
• Drafted and revised controlled documents under Manager and Quality oversight: SOPs, batch record versions, validation plans and documentation, technical reports, training records, equipment logbooks, and patient batch record copies and Certificates of Analysis for drug product.
• Entered and uploaded manufacturing data to the database in real time and documented operations in batch records and logbooks per procedure.
• Trained peers and new manufacturing staff on the process; supported facility GMP compliance, safety initiatives, critical reagent and material inventory reports, cryogenic material inventory and warehouse management.

Cell Manufacturing Associate at Fibrocell Science (2018-10 – 2020-03)

• Manufactured autologous cell therapy injections for RDEB (recessive dystrophic epidermolysis bullosa) using adherent mammalian cells under full aseptic gowning.
• Performed biopsy procedures, passages, cell feeds, vector filtration, transduction, harvest and cryovial freeze-down in 4 ft and 6 ft biosafety cabinets.
• Ran environmental monitoring by agar plating, cleanroom sanitization, and weekly and monthly preventive cleaning of biosafety cabinets, incubators, refrigerators and CFRs; disposed of hazardous waste per procedure.
• Reviewed batch records, SOPs and protocols, wrote revisions, and performed record reconciliation.
• Trained in warehouse operations (shipping, receiving, quarantine and release) and completed annual GMP training.

Biopharmaceutical Manufacturing Associate at GlaxoSmithKline (2018-05 – 2018-07)

• Supported upstream cell culture production of an asthma biologic: cell thaw, media and buffer additions, expansion, counting, sampling and wave bag rockers.
• Monitored pressure and energy on bioreactors and centrifuges, performed CIP/SIP sanitization and harvest sampling, and completed batch records and logbooks per SOP.
• Tested samples on ViCell XR and BioFLEX and ordered materials for processing.

Founder and Licensed Esthetician at GoodSkin Esthetics (2021-04 – Present)

Professional Development and Business Ownership, 2021 to Present

• Founded and operate a solo, state-licensed skincare practice; manage scheduling, inventory, vendor ordering, pricing, marketing and bookkeeping independently.
• Screen every client for contraindications at intake and document treatments, products used and post-care instructions in client records.
• Wrote treatment protocols and sanitation and disinfection procedures, applying the same SOP discipline used in cGMP manufacturing.
• Practice under Pennsylvania State Board of Cosmetology licensure and sanitation standards.

Licensed Esthetician (Part-Time) at Hand & Stone (2024-02 – Present)

• Evaluate client skin condition, interview clients for contraindications, and recommend treatments and products.
• Keep appointment schedules and client records accurate and on time.

Licensed Esthetician (Part-Time) at Cure de Repos (2022-08 – 2023-04)

• Evaluated client skin condition, interviewed clients for contraindications, and recommended treatments and products.
• Managed appointment schedule to keep services on time.

Master of Legal Studies in Healthcare Compliance – Drexel University, Thomas R.

Kline

School of Law (2021-05)

Master of Acupuncture (completed); Doctor of Acupuncture with TCM Herbal Medicine Certificate (in progress, expected August 2027) – Won Institute of Graduate Studies (2027-08)

Bachelor of Science in Chemistry – Alabama State University (2016-12)