Hadi Hazoor Bakhsh
Somerset,USA
Summary
Pharmaceutical Manufacturing Specialist with 5+ years of experience in GMP-regulated aseptic environments. Strong background in sterile manufacturing techniques and clinical materials testing. Skilled in team leadership, technical documentation, and cross-functional collaboration.
Overview
11
11
years of professional experience
Work History
Sterile Tech 2nd Shift
Merck & Co., Inc.
07.2024 - Current
- Perform all functions associated with complex formulation and process development, test and provide feedback on GMP SOP,s and protocols in support of sterile clinical drug products.
- Provide support in drug product aseptic processing, equipment and sterile technique aim of advance process development
- Part of all quality investigation and change management, equipment set up, batch processing planning and execution of performance run, water run, EMPQ runs, and Lyo engineering run.
- Provide input for incident RCA, reporting and action items.
Production Manager
Euroapstry
11.2021 - 07.2024
- Monitor, organize, and direct technical aspects of equipment installation, start-up, troubleshooting with commercial and experimental manufacturing of new frozen lines.
- Utilization of the DMAIC process, 6Sigma toolset for problem solving, Manage technical relationships with key suppliers/vendors and leverage these relationships to provide support for issue resolution
- Authoring SOP's for ISO compliance and other initiatives as required to create and implement standard work practices on the manufacturing floor
- Created streamlined production schedules and collaborated with production employees to communicate objectives and goals.
- Conducted root cause analysis on production issues, devising corrective actions to prevent recurrence.
- Monitor Process KPI's and provide operational evaluation as directed by the Senior Leadership
Clinical Research Scientist
Martin Dow Pharmaceuticals (Roche)
08.2014 - 08.2019
- Designed and executed formulation development, process development, process optimization and stability protocols.
- Provided scale-up and tech transfer support to commercial manufacturing facilities through process validation and subsequent manufacturing activities.
- Developed laboratory testing programs and generate SOPs, ECOs, batch records and work instructions.
- Ensured high-quality data collection by developing robust protocols and providing comprehensive training for clinical staff.
- Supported continuous improvement initiatives, conducting root cause analyses to identify areas for optimization in clinical trial operations.
- Designed, constructed and implemented research proposals, protocols and procedures.
- Accelerated drug development timelines by prioritizing tasks and collaborating closely with cross-functional teams.
Education
MS - Pharmaceutical Sciences
Bahauddin Zakariya University
Multan Pakistan04.2014
Pharm D - Pharmaceutical Sciences
Bahauddin Zakariya University
Multan Pakistan08.2008
Skills
- Experienced in manual and automated operations for technical transfer
- Sterile product manufacturing expertise
- Colloidal systems expertise
- Experienced in applying ISO, CFR, ICH, and USP standards to sterile product development
- Experience with liquid and lyophilized drug product formulation development
- Understanding of compliance and regulatory issues for sterile injectable products manufactured by aseptic processing
- Pharmaceutical manufacturing process management
- Ability to perform testing for development of clinical materials and stability samples to establish methods, specifications, and protocol's
Timeline
Sterile Tech 2nd Shift
Merck & Co., Inc.
07.2024 - Current
Production Manager
Euroapstry
11.2021 - 07.2024
Clinical Research Scientist
Martin Dow Pharmaceuticals (Roche)
08.2014 - 08.2019
MS - Pharmaceutical Sciences
Bahauddin Zakariya University
Pharm D - Pharmaceutical Sciences
Bahauddin Zakariya University
Publications
- Comparative in vitro study of antimicrobial activities of flower and whole plant of Jasminum officinale against some human pathogenic microbes. https://www.google.com/url?sa=t&source=web&rct=j&url=https://pdfs.semanticscholar.org/705a/93aea94d5de79a9642d821caac0e0dc36c12.pdf&ved=2ahUKEwjqqegIzvfiAhWDTd8KHYsrBjwQFjAAegQIBxAC&usg=AOvVaw2xCPznULOxuZ6fm3ghIBML&cshid=1561018269389
- Antimicrobial and phytochemical screening of Oligochaeta ramose against different pathogenic microbes. https://www.google.com/url?sa=t&source=web&rct=j&url=https://pdfs.semanticscholar.org/2316/87033da1af17691d3a5c4eb016973af4dbb6.pdf&ved=2ahUKEwid04GxqvjiAhVpUUNKHX9DkAQFjABegQIBRAC&usg=AOvVaw3UeMICILJVYJ_p8eIsnmO21
PROFESSIONAL DEVELOPMENT
Sanofi-Aventis Pharmaceutical Industry, Wah Cantt, Islamabad, Pakistan Pharmacist Intern 08/10/2008 – 08/10/2009 Trained in the Sterile Production Department (Formulation development + Aseptic processing), QC Department (specific training in HPLC, UV and GC instruments) and QA Department.
RESEARCH WORK
- 1) The pharmacological effects of crude extracts of natural plants Amberboa divaricata Kuntze and Parmelia Perlata (Huds.) Ach. on different isolated tissue preparations (jejunum, trachea and aorta) of rabbits.
- 2) The antibacterial effects of crude extracts of natural plants Amberboa divaricata Kuntze and Parmelia Perlata (Huds.) Ach. against growing media of two G +ve strains of bacteria, i.e., Staphylococcus aureus, Bacillus pumilus and two G -ve strains of bacteria, i.e., Escherichia coli, Citrobacter freundii.
- 3) The antipyretic effects of crude extracts of natural plants Amberboa divaricata Kuntze and Parmelia Perlata (Huds.) Ach. on rabbits.
- 4) The inhibitory responses of crude extracts of natural plants Amberboa divaricata Kuntze and Parmelia Perlata (Huds.) Ach. on some enzymes, i.e., acetylcholinesterase, butyrylcholinesterase, lipoxygenase and tyrosinase along with their free radical scavenger effect.
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