Elie Arslan, M.S., MBA, PgMP

• Provide senior quality consulting for GMP, GCP, and GLP, ensuring compliance with regulatory standards. • Conduct vendor qualifications and GxP audits to enhance quality assurance for start-ups. • Develop and align Quality Systems with QMSR for drug/device combination clients, ensuring regulatory adherence.

● Established a successful, strategic, phase appropriate, risk-based Quality Systems for non-clinical and early clinical phases. ● Oversee QA, Document Control & QC Microbiology activities. ● Oversee Cellics' training program and gown qualification using TalentLMS. ● Oversee GxP vendor audits program (GMP, GLP and GCP) for CROs, Study sites and contract test labs, and oversee internal audit program. ● Submit Annual Reports to the FDA (CBER) for IND and IND amendments. ● Developed in-house sterility testing per USP <71> and Growth Promotion Testing per USP <61> and USP <71> for GLP Test Articles and GMP IV Biologic Drug Products. ● Manage Vendor Quality Agreements and host Management Reviews ● Conduct QA review of non-clinical (GLP) study plans and clinical protocols for programs with stakeholders and CROs. ● Reduced costs of nonclinical GLP retain samples storage by ~$8,000 with CRO ● Review, sign off and disposition drug substance and drug product batch records. ● Successfully manage departmental budgets for Quality (QA/QC) & Program Management. ● Established a Quality Control Testing Media Fill Protocol for the Phase 1/Phase 2 Drug Substance and Drug Product Media Fills as well as the Master Cell Bank. ● Review program budgets and oversee milestones using Microsoft Project, develop timelines for non-clinical, CMC, clinical and Analytical Development. ● Developed clinical operations strategy for clinical labeling with a blood supplier. ● Oversee GMP dynamic environmental and personnel monitoring operations. ● Review non-clinical & process characterization data for non-GMP materials used for in-vivo studies. Support Regulatory with IND Amendment reviews. ● Manage testing for endotoxin, bioburden, sterility and growth promotion per USPs for clinical GMP lots & non-clinical GLP test articles. ● Oversee Particulate Testing for IV biologic GMP lots per USP <788> Microscopic Method II. ● Host a culture of continuous quality improvement by monitoring & improving KPIs

● Successfully managed a large team of Document Control and Technical Quality Groups with functions such as Document Control requests, Document Periodic reviews, ACE reviser role training, change control management, investigations, CAPAs, product impacting, equipment risk assessments, and technical quality agreements with clients. ● Attended monthly meetings and provided feedback in the Leadership Team. ● Improved KPIs of equipment PMs, and calibration with facilities and engineering group. ● Supported compliance team with client audits & Quality Management System. ● Co-hosted a successful FDA PAI inspection in May 2021. EIR received in August 2021. ● Co-hosted a successful Russian Regulatory Inspection in 2021. ● Chaired the Change Review Board (CRB) weekly meetings. ● Managed Technical Quality Agreements with clients (by reviewing, negotiating, and signing) and completing the annual reviews for Quality Agreements. Ensured agreements do not violate regulatory and Ajinomoto procedures. ● Completed various product risk assessments with clients. ● Signed off Annual Product Quality Reviews (APQRs) for commercial customers. ● Signed off executed validation protocols (IQ, OQ, PQ, PPQ) and summary reports. ● Signed off Quality System SOPs / Policies such as Site Master File (SMF). ● Supported Lab Systems and Director with ACE software Change Control workflow testing, CAPA and Deviation workflows, Performance Qualification (PQ) and design. Successfully transitioned from Master Control to ACE Quality System in 2021. ● Partnered with Project Managers and Business Development to finalize client Quality Agreements before starting clinical production or commercial production. ● Co-hosted / presented KPI data in the monthly Quality Council for Quality Metrics. ● Supported Regulatory team with Regulatory assessments for change controls and biennial CA FDB license renewals.

● Managed cGMP disposition of patient specific and neoantigen shared gene therapy clinical products and shipments (both domestically & globally following GDP / GCP). ● Performed client batch release following GMP, GCP and GDP. ● Successfully managed and completed the GMP Tech Transfer project with a client. ● Improved KPIs for Quality Systems. Over 90% of Document Change Requests, Deviations, NCRs and CAPAs were initiated, reviewed & closed in less than 30 days. ● Reduced cost of Maintenance (over $65,000 in savings) by transferring PM & Calibration in-house for certain equipment. ● Reviewed label proofs for clinical trial products per cGMP and GCP. ● Wrote/created Quality System procedures such as CAPAs, Deviations, Change Controls, water testing, Internal Audits and Risk Assessment per ISO 13485. ● Managed the company's quality systems and document control functions. ● Wrote Validation Plans, IQ, OQ & PQ protocols for instruments per GMP & ISO 13485. ● Supported equipment calibration / PM for GMP & Research Use Only (RUO). ● Performed/managed the internal (self-inspections) and vendor audits. ● Reviewed/approved R&D and Reagent Lab documentation per GLP. ● Reviewed instrument and reagent manufacturing production records and released BioXp instruments. ● Provided trend reports for deviations, change controls, CAPAs, OOS, NCRs and EM. ● Reviewed and approved deviations, change controls, CAPAs, NCRs and OOS. ● Tracked and reported Quality compliance metrics (KPIs). ● Performed quality risk assessments for all change controls. ● Reviewed/approved validation plans, validation protocols, validation reports and software change controls. ● Provided cGMP training to new hires and annual refresher GMP training.

● Managed the company's quality systems, procedures and policies. ● Managed GMP release of clinical products, released & completed kit inspections for Reagent Manufacturing. Released BioXp instruments. ● Reviewed instrument manufacturing production records. ● Managed Environmental Monitoring (EM) and cleaning programs of the GMP suite. ● Started/managed the internal and supplier audit programs. ● Hosted customer audits and Nemko Regulatory inspections. ● Reviewed and updated the Quality Agreements. ● Managed Change Controls and performed Regulatory Affairs assessments. ● Managed Document Control functions, NCRs, Deviations, performed risk assessments and CAPAs. ● Reviewed Quality Control Records for Reagent Manufacturing. ● Reviewed and signed IQs, OQs, PQs and Validation Reports. ● Provided customer support to sponsors for INDs & provided/reviewed CMC data. ● Completed EM Quarterly reports and annual deviation trend reports. ● Reviewed Statement of Work, and MSAs for Quality input.

● Managed the company's quality systems, procedures, and policies. ● Managed audit program (following cGMP & GCP) domestically and globally. ● Hosted over 70 clients, FDB and QP audits, provided and managed responses to audits. Over half of the hosted audits resulted in no observations. ● Improved number of audit observations from 4 to 1 per audit since Q4 2016. ● Supported various customers throughout Phases I, II and III of their studies with IVRS and GCP audits, drug reconciliation from clinical sites (blinded and open label studies) and documentation following GCP prior to closing the clinical studies. ● Created a Self-GMP Questionnaire in Q1. The Self-GMP Questionnaire saved the company 250 QA work hours and ~$25,000. ● Reviewed/approved controlled documents and ensured compliance with cGMP and GCP. Reviewed blinded label proofs. ● Managed vendor qualification program. Completed risk assessments and updated the Approved Vendor List quarterly. ● Reviewed/finalized customer Quality Agreements. Signed over 45 Agreements. ● Completed, reviewed/approved investigations, IQ/OQ/PQ validations, customer complaints, NCMRs, CAPAs, change controls, batch record review (for blinded and unblinded studies), commercial batches and clinical label proofs for various customers in pharmaceuticals, biologics and medical devices. ● Released packaged clinical lots and collaborated with project managers to ensure clinical trial products ship to sites. ● Ensured FDA registration and State FDB licenses (Drug and Device) were up to date. ● Reviewed Clients' Master Service Agreements with legal department. ● Oversaw QC Inspectors who monitor production activities. ● Oversaw API sampling (dispensing, storage & reviewed toxicology reports). ● Supported clients with PAI inspections & clinical product reconciliation per GCP. ● Supported clients with document archival, destruction activities for rejected clinical products/labels and clinical site closure audits.

Quality Assurance Manager – CMC Operations • Provided QA support for Halozyme’s partners Baxalta/Shire and their products. • Completed protocol reviews, study reports, QC data package audits and performed external vendor audits. • Completed ad hoc Regulatory Section audits and reviewed according to timeline requirements. • Supported implementation and testing of Veeva Vault before going live. • Reviewed Annual Product Reviews (APRs, APQRs) for Hylenex and HUA Drug Substance. • Performed Process Capability calculations for commercial products. • Initiated partner (Avid, Baxalta, Roche) change controls, reviewed, approved and implemented changes. • Ensured uninterrupted Drug Substance supply to Halozyme’s partners by working closely with the CMOs. • Completed disposition of Drug Substance and commercial Hylenex product per forecasted requirements. • Created new Quality System SOPs such as Quality Agreements and Batch Qualification Process. • Managed product complaint investigations, closures, reviewed monthly summary reports of ADRs and trending. • Worked closely with Pharmacovigilance team to complete complaint investigations reported by MedCom.

● Oversaw the company's quality systems, maintained procedures and policies. ● Approved controlled documents and ensured compliance with cGMP and GCP. ● Interacted with operations, project managers, and customers to address and resolve quality issues. ● Managed and maintained pest control, calibration, equipment and storage qualification and PM programs. ● Performed review/approval of batch records, pre- and post-execution and generated CofCs for customers. ● Reviewed/approved quality investigations, NCMRs, CAPAs, planned deviations and change requests. ● Maintained regulatory licenses and FDA filings. Hosted CA FDB State inspection with no observations. ● Prepared, maintained and tracked audit schedules (internal, supplier and host customer audits). ● Hosted over 50 customer audits in 2015, including 2 QP inspections, with no critical or major observations. ● Performed and supervised QC monitoring of packaging/labeling operations. ● Oversaw QC inspection activities, expired drug destruction and performed product/material disposition. ● Reviewed/approved IOQs for the new facility and approved/revised quality agreements with customers.

● Initiated, monitored/trended change controls, CAPAs, and investigations (Deviations and OOS/OOT). ● Reviewed/approved batch records and supported disposition of drug substances. ● Performed line clearances and provided QA floor support for upstream/downstream clinical manufacturing. ● Reviewed/approved QC data & QC method qualifications (Analytical Chemistry and Microbiology assays). ● Reviewed/approved and created/revised SOPs. Maintained SOP binders. ● Reviewed/approved calibration records, IQs, OQs, PQs & performed internal audits. ● Released raw materials, chemicals, components & container closures. ● Performed AQL for Fill Finish, released GMP bulk drug substances, buffers & media. ● Provided QA support to inspections & trained new QA staff on batch record reviews.

● Improved the CAPA Quality System process from 38% closed on time to 100%. ● Supported Clinical QA Director with Clinical QA (CQA) SOPs. ● Improved Document Management System by providing list of open/pending DCRs. ● Improved employee training by introducing elements of tracking SOP training. ● Reviewed, approved environmental monitoring data, QC Data, MBRs and processed/oversaw DCRs. ● Participated in product risk management activity with manufacturing engineers and senior management. ● Reviewed, approved, tracked investigations, microbiological excursions, validation protocols and reports. ● Maintained, reviewed, approved, tracked change controls, OOS and CAPAs. ● Reviewed stability data (using SLIMS) & reviewed batch records for clinical trials. ● Performed internal and vendor Audits as well as assisted with tracking documentation of GCP audits including documentation from clinical sites and reviewed clinical protocols. ● Reviewed, verified data for CMC sections and participated in CAB meetings. ● Provided QA support to QP Inspections and successfully developed a sample management spreadsheet. ● Successfully completed/submitted State Biennial Drug Manufacturing License Renewal Application.

● Determined sampling efficiencies by revising Microbiology SOPs. ● Communicated/informed the site about all environmental excursions and status of individual CAPAs. ● Ensured all investigations/CAPAs were completed timely and determined root cause analysis. ● Completed monthly and quarterly Environmental Monitoring Trend Reports ● Assisted Sr. Management with response to a Warning Letter from the FDA. ● Reviewed QC data and completed quality events for Ambisome commercial drug and Cayston Orphan drug batches.

Graduate courses: Biochemistry, Molecular Biology, Advanced Cell Biology I, Advanced Cell Biology II, Introduction to cGMP, Introduction to Regulatory Affairs, Clinical Development for Drugs & Biologics, Biological Processes in Regulatory Affairs, Gene Expression & Organization and Translational Biotechnology.

MBA in Global Management

Volunteer Research Experience California State Polytechnic University, Pomona 6/2003 – 6/2004 Molecular Biology/Microbiology lab Bacteria Water Testing Project for Silver Lake Research Corporation I detected Enterobacteriacae & coliforms using Silver Lake’s Watersafe test kit Yeast Cell Genome “DBF4 Promoter” Research I aided in devising a cloning strategy and construction of pSEY18GALREDDBF4