Mohammed Shihadeh
Amman
Summary
With a proven track record in analytical research and development, this profile reflects extensive expertise in pharmaceutical data analysis, quality control, and regulatory compliance. Currently serving as an Analytical Research Manager at Hikma Pharmaceuticals, responsibilities include leading a team to maintain high standards in analytical testing and data integrity for FDA-compliant submissions. Skilled in managing cross-departmental projects and contributing strategic insights for global product registration, with a focus on delivering precise, data-driven solutions and fostering team development. Dedicated to advancing rigorous standards and supporting impactful innovations in pharmaceutical research and development.
Overview
27
27
years of professional experience
1
1
Certification
Work History
Medical analyst
Alaref medical Laboratory
07.1997 - 03.2002
- Perform all medical laboratory tests
Analytical Research Maneger
Hikma Pharmaceuticals
03.2002 - Current
- Supervising an analytical research section.
- Supervising team personnel and coordinating between section supervisors.
- Update material safety data sheet for laboratory materials & follow up safety issues.
- Following on pull out dates for MENA submission stability samples.
- Supervising new analytical methods development.
- Supervising analytical method validation.
- Providing input to registration department to register products worldwide.
- Reviewing raw materials and finished product specifications.
- Reviewing and follow up on accelerated stability studies.
- Coordinating professional development and training of analytical research personnel.
- Coordinate between departments over the execution of assigned Analytical Research and R&D projects.
- Reviewing analytical testing for submission stability samples for products developed for Hikma Jordan
- Reviewing and approved stability submission results
- Reviewing out of Specification, out of trend, and variance reports and approved the root cause, corrective and preventive action
- Data review and evaluation
- Ensuring that all our works under high quality standard and as per the FDA requirements
- Supervising team personnel and coordinating between section supervisors
- Ensuring cGMPs development and training of analytical research personnel
- Providing analytical troubleshooting to team members
- Coordinate between departments over the execution of assigned Analytical Research and R&D projects
- Providing input to registration department to register products worldwide
- Coordinating professional development and training of analytical research personnel
- Reviewing finished product results, specifications and justification of specification
- Follow with MENA and US sites for any support and follow up
- Replying to regulatory authorities requests
- Reviewing and follow up on accelerated stability studies
- Following on pull out dates for MENA and US Submission stability samples
Corporate Development Supervisor
Hikma Pharmaceuticals
08.2013 - 05.2015
- Research to find outsourced pharmaceutical products
- The conclusion of agreements with supplier companies
- Our Business is the transfer of technology and API supply or Licence, distribution, and supply agreement
- Negotiate price with supply companies
- Calculated preliminary feasibility of the product
- Communication with finance to calculate feasibility study
- Review the agreement terms with the legal Department
- Review all documents available in supplier to check is suitable to register
- Review the registration file
- Discussion the marketing center about the products interested
- Communication with the department of invention patents to see the patent for the development of products in the region
- Follow-up technology transfer with the R&D and the file review
- Follow-up stability data with the supplier company if the supplier develop the product
- Follow up the due diligence with regulatory team and file check
- Review file with R&D and regulatory team
- Performed confidential agreement (CDA) with supplier companies
- Performed term sheet, discuss and review
Education
Bachelor of chemistry -
Petra University
Jordan06.2009
Diploma of medical analysis -
Al Zarqa Government College
Jordan06.1995
Skills
- Teamwork
- Problem-solving abilities
- Multitasking
- Team leadership
- Time management abilities
- Adaptability
- Professionalism
- Staff Supervision
Personal Information
- Place of Birth: Amman
- Date of Birth: 10/20/74
- Gender: Male
- Nationality: Jordanian
- Marital Status: Married
Languages
Arabic
Proficient
C2
English
Advanced
C1
Certification
- Employee Engagement Training course, Linkedin Learing - November 2023
- Finance for Non-Financial Managers Training course, Hikma Pharmaceuticals - November 2023
- Data Integrity Training Course, Zonetechs - September 2023
- Listening Skills Training course, Septa Academy - January 2022
- English Speaking Basics and Fundamental Level 2 course, Septa Academy - January 2021
- Business writing Training Course, Mobileznation House of Digital Innovation - March 2020
- Solid State and Crystallization of Small Molecules Training course, CDP innovation - February 2020
- Business Etiquette, Hikma Pharmaceutical - January 2020
- An Introduction to LC Method Translation, Hikma Pharmaceuticals - October 2018
- Stability Testing of Drug Substance & Drug Product Training course, Apex pharmaceutical services - August 2018
- Fundamentals of Management and Coaching Workshop - Hikma Pharmaceutical - March 2016
- Communication Skills Course, Hikma Pharmaceutical - March 2016
- Data Integrity and Audit Trials, CPD Innovation - September 2015
- Managing Deviation in compliance with the latest Regulatory Guidelines
- Performing under pressure
- Corporate Criminal offence – Failure to Prevent Tax Evasion
- Teamwork and Collaboration
- Planning and Organization for the Professional Course
- Work injuries
- Negotiation Skills
Timeline
Corporate Development Supervisor
Hikma Pharmaceuticals
08.2013 - 05.2015
Analytical Research Maneger
Hikma Pharmaceuticals
03.2002 - Current
Medical analyst
Alaref medical Laboratory
07.1997 - 03.2002
Bachelor of chemistry -
Petra University
Diploma of medical analysis -
Al Zarqa Government College
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