
Elie Arslan S
GCP Certified, Six Sigma Green Belt Certified, Program Management (PgMP) Certified, diligent, ambitious, Quality and Compliance driven, observant... | San Diego, California, United States
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Elie Arslan S’s Emails ea****@ce****.com
Elie Arslan S’s Phone Numbers No phone number available.
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Elie Arslan S’s Location San Diego, California, United States
Elie Arslan S’s Expertise GCP Certified, Six Sigma Green Belt Certified, Program Management (PgMP) Certified, diligent, ambitious, Quality and Compliance driven, observant leader, with 20 years of industry experience. I am experienced in Biopharmaceuticals, Biologics, and Medical Devices, knowledgeable in GxP (GMP, GCP, GLP and GDP), with an MBA in Global Management and a Master of Science in Biotechnology, can multitask, oversee various Quality and Regulatory responsibilities, and thrive in a fast-paced dynamic environment. I have over 10 years of CMO experience, including experience in releasing drug substances, drug products vial and syringe aseptic filling, aseptic filling operations for small scale clinical trials to commercial automated large-scale production, experience small molecules, large molecules, routine testing for solid oral dosage forms, oncology as well as patient specific gene therapy. I was a Keynote Speaker in two Global Quality webinars during the COVID-19 Pandemic in 2021. I have broad experience in Quality Assurance, Quality Control and Regulatory Compliance. Some of my main specialties include: Document Control, Technical Quality Operations, Internal Auditing, Quality Auditing (hosting Regulatory audits, customer audits and performing supplier audits), managing vendor qualification, managing Quality Agreements with customers or partners, reviewing/tracking/providing Metrics, Data Trending, data review, batch record review, GCP, product release, risk assessments, Environmental Monitoring, Aseptic Processing, GMP training, GDP training, QSRs, 21 CFR Part 11, 21 CFR 312, 610, 21 CFR 820, EudraLex Volume 4, Annex 13, QA oversight of upstream/downstream manufacturing, review of validation protocols/reports, Stability program, QC Method Qualifications, LAL Testing, bioburden testing, water testing, growth promotion, Quarterly Environmental Monitoring Trend Reports and Validation.
Elie Arslan S’s Current Industry Cellics Therapeutics
Elie
Arslan S’s Prior Industry
Gish Biomedical
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Gilead Sciences
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Sangart
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Tanvex Biopharma Usa
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Sherpa Clinical Packaging A Pci Pharma Services
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Halozyme
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Sherpa Clinical Packaging
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Sgi Dna A Synthetic Genomics
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Codex Dna
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Ajinomoto Bio Pharma Services
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Cellics Therapeutics
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Work Experience

Cellics Therapeutics
Associate Director of Quality and Program Management (Head of QA and PM)
Wed Mar 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Cellics Therapeutics
Associate Director of Quality Assurance, Facilities and Program Management
Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Feb 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Cellics Therapeutics
Associate Director of Quality Assurance
Mon Aug 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Oct 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Ajinomoto Bio Pharma Services
Manager, Technical QA and Document Control
Tue Dec 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Aug 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Codex Dna
Senior Manager, Quality Systems
Wed May 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Dec 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Sgi Dna A Synthetic Genomics
Manager of Quality Assurance and Regulatory Affairs
Fri Jun 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed May 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Sherpa Clinical Packaging
Quality Manager
Sat Oct 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jun 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Halozyme
Quality Assurance Manager
Sun Nov 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Oct 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Sherpa Clinical Packaging A Pci Pharma Services
Quality Manager
Mon Dec 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Nov 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Tanvex Biopharma Usa
Sr. Quality Assurance Associate
Fri Mar 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Dec 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Sangart
Quality Assurance Specialist I
Tue Mar 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Mar 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Gilead Sciences
Quality Control Specialist II
Fri Aug 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Feb 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Gish Biomedical
Microbiologist
Mon Nov 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue May 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)