Marc E Resume

Marc Elias

Natick, MA *****, Phone: 508-***-****

********@*****.***

Objective: Seeking a position in Biotech/Pharma in QC: HPLC Expert resolving & troubleshooting analysis, procedures review, LIMS, Lab Audit, QC Data Reviewer, 5S, remediate lab issues, results oriented.

Also seeking QA/ Documentation, GxP Quality Auditor, Master Batch Record Reviewer (EBR / MBR) & corrective actions, Develop Solutions, Remediations, Gap Analysis. Project Management and other management or non-management level positions. Available for Remote, Hybrid, onsite position or mix. Summary:

• Experience in resolving QC and QA related to manufacturing of biopharmaceuticals and pharmaceuticals. Also, remediate issues. Good knowledge of FDA, EMEA and other applicable

• industry Familiarity and with quality working regulations. with GMP Some manufacturing experience facilities on medical or CDMOs devices. during tech transfer and/or

• cGMP Strong manufacturing. analytical and problem-solving skills, with the ability to apply scientific and engineering

• principles Strong analytical to complex and technical problem-solving problems skills, and with data the trending ability to with apply minimal scientific input. and engineering

• principles Understanding to complex of cGMP technical regulations problems and requirements and data trending for manufacturing with minimal input. cell therapies or other

• biologics. Proficiency in authoring and reviewing protocols and reports that support GMP manufacturing and

• • regulatory Ability Over two to meet decades filings. deadlines, of hands-adapt on experience to rapid changes, and results and work oriented in a in fast-Quality paced Management team environment. System, QC / QA / QMS and documentation practices in GMP environment

(Biotechnology, Biopharmaceuticals and Pharmaceuticals). Details oriented; results driven. Thrive in fast pace environment, CRO, CLO & CMO, multidisciplinary environments.

• Strong Auditing and remediation experience vs ISO9001 and support Continuous Improvement

• • initiatives programs, Right First and Time project (RFT) management. practices to reduce Great the experience waste/rejection in Drug and Product efforts / Drug and increase Substance. efficiency

• • • and “OPEX/Strong Excellent applying knowledge Lean/management, Six Sigma. base in business Used all aspects statistical and of leadership quality system including DARA. experience Risk quality Management to guide control, the calibration, department and Assessment. validation. to right path for best GXP/GDP/DI/ALCOA+ practices. Also, capable of resolving multiple issues

• simultaneously. Expert in final reviewing biopharmaceuticals Batch Records (MBR/EBR), finished products, in-

• process, Expert in stability auditing, and pre-CoA. audit, audit readiness experience to make sure compliance with GMP/GXP/GDP/Data Integrity/ALCOA+ and 21 CFR Part11 with FDA regulations and with other agencies. Brought great ideas to prevent and reduce major/critical observations and reduce

• number Critical technical of deviations/skills, Investigations. accurate, organized recording, lab safety, regulatory compliance, process improvement, and service delivery for increased efficiency. Experience in small and large molecules.

• • Talented Using electronic at multi-systems: tasking, verbal SAP, LIMS and written (Labvantage communicating and Citrix)across, Trackwise, departments. Veeva, DARA, and

• BlueMountain. Expert in training, coaching/mentoring new team members on new procedures. Also, collaborate with functional leads to ensure effective communication to resolve critical issues. Knowledgeable in Microsoft Office tools, Electronic Document Management Systems. Expert in ICH-GCP guidelines, CFR Title 21, Part 11, and delivering GxP., DMAIC” Adaptable, flexible and able to work under high pressure and fast pace environment. Dealing with customer complain issues and resolutions. Also, I have excellent interpersonal, communication, negotiating, influencing, and manage the creation and maintenance of compliance metrics, development of trend data of audit / inspection observations and communication of results expediently to applicable groups. collaboration skills. Biotechnology and Pharmaceuticals international experience.

• Experience with multiple electronic systems: Plateau, NuGenises, ISOtrain, with knowledge of

• API Expert & ASTM, with pre-MSDS, approval OSHA, of investigation, 5S & LEAN Sigma. deviation, Validation Root Cause (IQ, Analysis OQ, PQ)(. RCA), CAPA, OOS,

• • OOT, Over Lead 30 continuous and years’ LE. experience improvement of EH&on targeted S and usage business of PPE. processes, using Lean Sigma, to reduce deviations.

Experience and Achievements:

Various Companies May-2024 to Jun2025

Sanofi / BMS: QA Manager (Complementary / Temporary Position) Reviewing deviations in VEEVA QMS as per GMP, GDP, Data Integrity and ALCOA+.

• • • • I Do I Led reduced achieved weekly and supported project $quality 400k kickoff in metrics investigations cost timeline savings for: Stand by via for 14 Alone, process non-hours conformances, Effectiveness automation. by standardizing deviations, Check, client and intake OOS/Action OOTs, process. / CAPAs. ensuring root

cause analysis and timely closure in compliance with cGMP requirements. Performed impact and risk assessments to support product quality, patient safety, and accurate batch disposition decisions.

• Provided QA oversight during manufacturing and QC activities, ensuring adherence to site procedures and global quality standards.

• Supported batch disposition activities by reviewing investigation outcomes, CAPAs, and associated documentation.

• Partnered cross-functionally with Manufacturing, Engineering, and QC to resolve quality events and implement effective corrective actions.

• Authored and reviewed clear, compliant investigation reports, ensuring data integrity and traceability throughout the quality lifecycle.

• Assisted during internal and external audits/inspections, providing documentation support and responding to quality observations.

• • • • Reviewing Bring Done I have the Auditing 5 years best Master for and of experience the Batch report team Records observations. for leading Right / EBR. First high Time performing (RFT) project Process team. Improvements and efficiency. Gsk vaccines, MA Jul-2023 to Feb-2024

Senior Investigator, Supply Chain / Manufacturing (Complementary / Temporary Position)

• Professionally reviewing Manufacturing Batch Records (MBRs) data reviewing and remediation to multiple issues and implemented training to manufacturing, Supply Chain and warehouse teams. Improved MBR personnel’s performance (Right First Time) by suggesting excellent training

• system, Conduct led regular by examples inspections as per and GDP/audits Data Integrity of production and ALCOA+processes . to identify quality issues

• and Prepare NCR's. and gather statistics, using statistical system DARA for quality council monthly senior management monthly

meetings presentation.

• Investigate and analyze the Root cause and developed CAPA. Change control by revising SOPs to improve

performance of whole department, and to reduce number of deviations.

• Reviewing Investigations & Deviations for supply chain dept., using SAP system and other

• systems Trained supply (i.e., BioIT)chain . groups on GDP/GMP/Data Integrity/ALCOA+, by presenting many PowerPoint slides with live

examples on how to do it Right First Time (RFT).

Eurofins Pharmaceutical Science / Consultant & Various Companies, MA Mar-2017 to Dec- 2022

QA Specialist Compliance

• Project management and proficient with Deviations/Investigation/Trackwise/Veeva, QMS, RCA, CAPA, OOS, OOT, and LE. Also reviewed Batch Records (MBRs), Data Packages generated by different levels of analysts, Validation

Protocols, column steps and peer review for accuracy and compliance. Reviewing experience of documents. Also, remediate issues and developed plan to reduce number of deviations in QC/QA Dept.

• Worked on Veeva, Business Analyst responsibilities and gathering documentation and implementation eQMS.

• Worked with Contract Development Manufacturing Organizations (CDMO, Drug Development, ...) for

biopharmaceuticals products. For clinical and commercial products.

• Change control by revising SOPs to remediate as corrective actions to improve performance of whole department, and to reduce number of deviations.

• Apply problem solving skill to achieve a compliant resolution from R&D, MFG, Tech Service.

• Managed Quality team and directed them to best and top GDP/DI/ALCOA+ practices in GMP environment to

investigate deviations in quality systems, and find solutions. Also trained the team on how fill gaps in quality systems

by creating CAPA. Reviewing QC / QA data and LIRs. Experience with commercial stability samples.

• Brought the best ideas and solutions to quality system, to eliminate gaps and reduce the number of deviation and

investigations drastically.

• Build effective network and communication with Plant Leadership Team, Quality and Regulatory functions, other plant

Quality Managers and other key functions of Engineering, Supply Chain, etc. to ensure alignment around global and local priorities and in driving overall plant performance relying on a strong culture of Quality and Continuous Improvement.

• Lead continuous improvement on targeted business processes. Able to formulate a strategic approach for difficult complex issues.

• Independently perform issue analyze assessments and determine impact.

• Investigating OOS/OOT/QE using TrackWise/Veeva systems. Also root cause analysis (RCA), and deviations trending.

• Resolved direct reports issues and held meetings within departments and externally.

• Auditing experience and walkthrough to QC, Manufacturing, Warehouse and Packaging, to make sure compliance with GMP/GXP/GDP/Data Integrity/ALCOA+, as per FDA regulations. Also, to prepare for FDA, TGA, Health Canada and EMA Auditing/inspection.

• Provide leadership directions/objectives, coaching and personal development of Associates to perform to their best ability and meet both personal and plant objectives.

• Highly organized within the group and on multiple levels on daily activities.

• Able to communicate efficiently, internally and externally to get the job done to final stage on timely manner.

Sanofi/Genzyme, MA Feb-2012 – Dec-2016 Senior QC Analytical Chemist

• Pre-Auditing preparation experience for FDA, Canadian and EMEA inspection.

• Professional review of QC data and LIRs. Proficient in testing Biopharmaceuticals: Finished Products, in-process and

stability samples using: HPLC, U V spectrophotometer for PNP, Bradford & A280. Proficient using and testing Atomic

Absorption Spectrometer (AA) samples for sodium and zinc.

• Investigation experience for OOS/OOT and capable of opening QE using TrackWise/Veeva systems. And finding the

root cause analysis and doing CAPA for critical and major deviations.

• Verifying data packages, verifying test results in GMP & None GMP environment. Also, troubleshooting methods and HPLCs and other lab instruments.

• Perform QC data packages review for Drug Product / Drug Substance, and approval of documents before product release. Proficient using LIMS system.

• Tracking and trending of generated QC data to make sure analysis results within specification.

• Run Method Validation protocols on different analysis, to validate methods.

• Ability to analyze a problem/situation and recommend solutions.

• Tested samples and troubleshoot HPLC Chemstation/Empower, POROS/Concentration, SEC/Aggregation, etc. analysis for in- process stability and finished products, etc. for lyophilized/Injectables and biological products.

Abbott Labs and Other Co. (QC Analytical Chemist / Research Associate). 2002-2009 HPLC, UV, SDS-PAGE, TOC, LIMS, Reviewing QC Data, Lab Auditing, Data Integrity, GDP, GMP.

Education & Skills: Toronto University Evaluation D. University, Faculty of Science (Possess USA Equivalency) Bachelor of Science Degree (Four Years) Applied Chemistry. IQ, OQ and PQ Chemistry Lab Courses: HPLC, LC-MS, GC and Lab. Assay Methods. Computer courses: CBS: Microsoft Office. Toronto, ON. Sep-1998 Courses & Seminars:

Lead Auditor (ISO-19011:2018) 13Jun24 Lean Sigma Green Belt 02Mar24 ISO Management System Audit Techniques and Best Practices 28Feb24 Medical Devices, Quality Management Systems (ISO-13485 :2016) 24Feb24 Internal Auditor Certificate (ISO-9001 :2015) 05Sep21

Lead Auditor, Auditing Techniques for Clinical Research Professionals (Barnett International), Drug Safety and Pharmacovigilance, cGMP: Good Manufacturing Practice & GCP: ICH Good Clinical Practice

(ICH-GCP).

Project Management, Time Management skills, LC-MS Techniques, Interpretations & Instrumentation, Method & Instrument Validation, Ion Chromatography and few HPLC courses. GSK Short courses: EH&S, WHMIS, Network Exchange, Multichrom, Lean Sigma, Words L-2, Method & Instrument Validation

(PSG), CVG seminars & GMP.

Honors and Awards:

Received a Abbott Labs Certificate Award for completing successfully five years contributing to success of launching active pharmaceutical ingredient, working in QC Labs. Memberships: Member of American Society for Quality.

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