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Maroun George Elias, MSc

Supply Chain Specialist - Global

WILLING TO RELOCATE. Actively seeking a new role within the pharmaceutical industry

Somerset, New Jersey

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Maroun George Elias, MSc's Email Addresses & Phone Numbers

Maroun George Elias, MSc's Work Experience

Beta Pharma, Inc.

Supply Chain Specialist - Global

January 2014 to January 2015

Princeton, NJ

Beta Pharma, Inc.

Regulator Affairs and Business Development Manager

December 2013 to January 2014

Princeton, New Jersey

Beta Pharma, Inc.

Regulatory Affairs/ Business Development Associate

August 2013 to December 2013

Princeton, NJ

Maroun George Elias, MSc's Education

New Jersey Institute of Technology

Master of Science (MSc) Analytical Chemistry

2010 to 2012

Rutgers, The State University of New Jersey-New Brunswick

Bachelor of Arts (B.A.) Chemistry

2007 to 2009

Middlesex County College

Associate of Arts and Sciences (A.A.S.) Chemistry

2005 to 2007

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Maroun George Elias, MSc's Estimated Salary Range

About Maroun George Elias, MSc's Current Company

Beta Pharma, Inc.

The Supply Chain Specialist is a key role providing expertise and support for a broad range of responsibilities in Supply Chain that may include Strategic Sourcing, Procurement, Supplier Relationship Management, and Inventory. The overall goal of supply chain management is to reduce costs and increase efficiency throughout the supply chain process while ensuring that quality, safety, and...

Frequently Asked Questions about Maroun George Elias, MSc

What company does Maroun George Elias, MSc work for?

Maroun George Elias, MSc works for Beta Pharma, Inc.


What is Maroun George Elias, MSc's role at Beta Pharma, Inc.?

Maroun George Elias, MSc is Supply Chain Specialist - Global


What is Maroun George Elias, MSc's personal email address?

Maroun George Elias, MSc's personal email address is m****[email protected]


What is Maroun George Elias, MSc's business email address?

Maroun George Elias, MSc's business email addresses are not available


What is Maroun George Elias, MSc's Phone Number?

Maroun George Elias, MSc's phone (201) ***-*387


What industry does Maroun George Elias, MSc work in?

Maroun George Elias, MSc works in the Pharmaceuticals industry.


About Maroun George Elias, MSc

📖 Summary

Regulatory Affairs professional having experience working in the regional headquarters of a pharmaceutical Global companies. I have Demonstrated analytical and communication skills that encompass identifying critical concepts, solving complex problems, presenting complex ideas in a clear, concise and persuasive manner and keen attention to detail. Proven ability to effectively manage time and multiple projects, contribute effectively to project teams, achieve deadlines and collaborate with colleagues on a global level. Possesses extensive Knowledge of US FDA regulations, ICH, GCP, GMP, Quality Standards, Quality Management. I overviewed Premarket approval, PMA supplement. Comprehension of IND, NDA/ANDA, BLA Supplements as per 21 CFR 312, 314, 600 amendments & Annual Report submission following eCTD format and labeling compliance with drugs, OTC, Biologics and Cosmetics Products, as well as Knowledge of Chemical, Manufacturing and Control (CMC), Clinical and Non-clinical Submission. My IND experience is primarily with one of the 3 types of IND which is “Treatment IND” for commercial use. 1) Submissions of all module I,II, III, IV, V 2) Animal Pharmacology and Toxicology studies (Pre-clinical data to evaluate the safety of the drug for initial testing in humans) 3) Manufacturing Information (CMC) to gather information of the composition, manufacturer, stability to ensure the consistency of batch production 4) Clinical Protocols to ensure the safety of subjects. Obtain informed consent and IRB approval of the studySupply Chain Specialist - Global @ The Supply Chain Specialist is a key role providing expertise and support for a broad range of responsibilities in Supply Chain that may include Strategic Sourcing, Procurement, Supplier Relationship Management, and Inventory. The overall goal of supply chain management is to reduce costs and increase efficiency throughout the supply chain process while ensuring that quality, safety, and customer satisfaction is not negatively affected. Work to develop efficient, cost-effective supply chain strategies and manage inventory. In conjunction with the management, establish department objectives and procedures. Develop and maintain positive, productive, proactive relationships with a wide variety of suppliers and distributors. Manage relations with vendors, communicating requirements such as quantity, delivery times, and quality. Resolve supplier issues to minimize impact to operations. Manage supplier relationships and track Key Performance Indicators (KPI’s) to evaluate and report performance. Negotiate, contract, and implement preferred supplier agreements. Interfaces successfully with the company’s various business units, Business Development, R&D and Operations to insure timely and effective project implementation. Perform other duties as requested, directed or assigned. From January 2014 to January 2015 (1 year 1 month) Princeton, NJRegulator Affairs and Business Development Manager @ Regulatory Affairs professional having experience working in the regional headquarters of a pharmaceutical Global companies. I have Demonstrated analytical and communication skills that encompass identifying critical concepts, solving complex problems, presenting complex ideas in a clear, concise and persuasive manner and keen attention to detail. Proven ability to effectively manage time and multiple projects, contribute effectively to project teams, achieve deadlines and collaborate with colleagues on a global level. Possesses extensive Knowledge of US FDA regulations, ICH, GCP, GMP, Quality Standards, Quality Management. I overviewed Premarket approval, PMA supplement. Comprehension of IND, NDA/ANDA, BLA Supplements as per 21 CFR 312, 314, 600 amendments & Annual Report submission following eCTD format and labeling compliance with drugs, OTC, Biologics and Cosmetics Products, as well as Knowledge of Chemical, Manufacturing and Control (CMC), Clinical and Non-clinical Submission. My IND experience is primarily with one of the 3 types of IND which is “Treatment IND” for commercial use. 1) Submissions of all module I,II, III, IV, V 2) Animal Pharmacology and Toxicology studies (Pre-clinical data to evaluate the safety of the drug for initial testing in humans) 3) Manufacturing Information (CMC) to gather information of the composition, manufacturer, stability to ensure the consistency of batch production 4) Clinical Protocols to ensure the safety of subjects. Obtain informed consent and IRB approval of the study Met with many regulatory agencies in ASEA and attended many pre IND meeting as well as meeting with physicians to champion our drug. Beta Pharma, is a new established Chinese pharmaceutical specializing in Oncology, during my employment there I have submitted 3 IND, attended 5 pre IND meeting and three oncology conferences. The last conference was in Chicago, IL. From December 2013 to January 2014 (2 months) Princeton, New JerseyRegulatory Affairs/ Business Development Associate @ I establish relationships with country personnel, regulatory bodies and appropriate company personnel to expedite the product registration process. I remain updated with new regulation for drug development projects in order to assist in the development of departmental strategies. I am also responsible for marketing and promoting pharmaceutical drugs and medical devices, while following global protocols. From August 2013 to December 2013 (5 months) Princeton, NJAnalytical Scientist @ From May 2013 to November 2013 (7 months) New Brunswick, New JerseyRegulatory Affair Consultant @ Prepared, reviewed and submitted regulatory submissions to the FDA Submissions include ANDAs, amendments, supplements, annual reports Evaluated changes to regulatory documents and formulates strategies to maintain submission goals. Interacted with FDA via written and phone communications. Managed review and approval of all packaging components (e.g cartons, lables, Physicians Inserts, Patient Inserts, and Medication Guides) for assigned products. Ensured documents adhere to regulatory and internal requirements Worked closely with internal and external customers to ensure timelines are being followed and customer needs are met Assisted Regulatory Leads with the creation/ modification of submission documents, including Structured Product Labeling (SPL) Assisted with the creation of Company Core Data Sheets (CCDS) Assisted team with proofreading of all Labeling documents Maintained awareness of regulatory legislation, guidance, and practice pertaining to assigned product/project areas Assured compliance with regulatory requirements Maintained compliance with regulatory requirements for generic drugs for the US market. Interacted with the Federal Trade Commission to better evaluate the “Made in USA” claim, then interacted with legal and Quality Affair to help them understand the policy related to the above statement Familiar with the “Advertising” guidance for OTC products From July 2012 to August 2012 (2 months) Senior Research Chemist @ Established and validate testing methodology used to control raw materials, production intermediates, and final products in support of Research and Development, Quality Control and Manufacturing activities Developed analytical methods to support in-process, release, characterization and specification testing of active pharmaceutical ingredients. Performed Method Validation for Dissolution and Assay as well as Method transfer to Quality Control Laboratory. Developed methods for single and multi component API Performed IQ, OQ and PQ and instrument validation Assisted with set-up of new or existing methods for identifying compounds, their validation and documentation. Conducted testing of analytical samples for laboratory area, the separation and characterization of drug candidates and their impurities, formulation development, and other analytical methods of development. Utilized analytical and chromatographic equipment such as MS & HPLC Performed Assay, content uniformity and Blend uniformity Performed Impurity testing of raw materials and In process Drugs Helped calibrating Lab instruments Strong knowledge operating Empower software Maintained good laboratory notebooks Followed strictly GMP regulations Trouble shooting Water/Shimadzu LC instrument Checked the Goods Received Note (GRN) and observed batch number, material code, name of material, name of the manufacturer/vendor, manufacturing/expiration date, quantity received, approved, and rejected. Requested Quality Control (QC) Department for sampling of received goods Collected Certificate of Analysis (COA) from QC and compared results with vendor’s COA. Helped in preparing Batch Process Control Records (BPCRs), Standard Operating Procedures (SOPs), and Standard Testing Procedures (STPs) From September 2009 to May 2012 (2 years 9 months) Chemistry Internship @ Studied the effects of various factors like buffers with different concentrations, composition of mobile phase and pH on retention mechanism, overloaded band profiles and adsorption isotherms of ibuprofen by using Shimadzu HPLC-20A, and stationary phase Alltech-C18 Performed Accelerated stability testing for various drugs. Studied disintegrating mechanism of various dosage forms by using Disintegration test Apparatus. Performed dissolution testing for various drugs using different buffer solutions. Synthesized new Anti-Microbial compounds and obtained satisfactory results on invitro testing. Tested the intermediate and final compounds by performing TLC and compared the retention factor with the lead compound. Performed invitro biological testing of the synthesized compounds by using Bacteria and Fungi From January 2009 to June 2010 (1 year 6 months) Master of Science (MSc), Analytical Chemistry @ New Jersey Institute of Technology From 2010 to 2012 Bachelor of Arts (B.A.), Chemistry @ Rutgers, The State University of New Jersey-New Brunswick From 2007 to 2009 Associate of Arts and Sciences (A.A.S.), Chemistry @ Middlesex County College From 2005 to 2007 Maroun George Elias, MSc is skilled in: Speak and write French, Speak and write Arabic, Speak Spanish, Computer Repair, HPLC, HPLC-MS, GCP, Methodology, Analytical Method..., Instrument Validation, Analytical Chemistry, GMP, FDA, Formulation, Dissolution, Regulatory Affairs, Pharmaceutical Industry, SOP


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In a nutshell

Maroun George Elias, MSc's Personality Type

Extraversion (E), Intuition (N), Thinking (T), Judging (J)

Average Tenure

0 year(s), 11 month(s)

Maroun George Elias, MSc's Willingness to Change Jobs

Unlikely

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