Usman Ishaq
Navan,MH
Summary
Experienced professional with focus on pharmaceutical operations and production. Ensure high-quality manufacturing through strict adherence to GMP and safety protocols. Accomplished professional with extensive expertise in manufacturing operations, quality systems. Skilled in batch record review, deviation management, and scientific writing. Adept at chromatography skid operations, including affinity and ion exchange chromatography, as well as viral inactivation and filtration techniques. Proficient in the use of DeltaV, MES PAS-X, SAP, and other industry-standard software. Committed to process improvement and lean manufacturing principles to enhance operational efficiency. Career goal: to leverage technical support and problem-solving skills to drive innovation in biopharmaceutical manufacturing.
Overview
8
8
years of professional experience
7
7
years of post-secondary education
Work history
Manufacturing Biotech Associate
MSD Dunboyne Biologics
Dunboyne, Ireland
09.2022 - Current
- Performed variety of tasks including process executing and monitoring to assure product quality and manufacturing throughput. Successfully executed Engineering, PPQ and Clinical Batch.
- Worked with teams across different Hubs to ensure all aspects of Business remain in compliant and in audit ready state.
- Liased with cross functional teams to resolve production related issues and foster collabration across different departments.
- Attended Downstream workshops to analyse complex production data, Identify process gaps, and propose effective solutions to streamline operations and enhance prodcutivity to meet cadence target.
- Continuous Improvement suggestion to reduce downtime and to ensure all CPPs are in acceptance criteria. EBR update suggested and implemented for downstream workflows to ensure contemporaneous SAP consumptions. Change Controls to update Downstream setups and Processing SOPs
- Prepared and presented elog usage process to auditors and successfully answered queries. Supported Incidents and investigations closures for HPRA Audit and Safety Audit readiness walks on Manufacturing floor.
- Completed full MFG review of downstream, Sol prep and Equip Prep EBRs to support PPQ closure. Supported QA with understanding MBR build issue regarding review process.
- Provided trainings across shifts on Column Packing, Single use TFF Cytiva skids and other chromatography skids as Part of Capability Project.
- Supported CQV in shakedown of Equipment and Automation Recipes updates on Chromatography and UFDF as Part of Product Change over and Area readiness.
- Supported upstream with harvest setups, decontamination, breakdowns and autoclave activities
- Material Coordinator role to ensure material availability to run activities successfully, Delivery champion role to manage multiple priorities in Downstream and escalated issues for resolution.
- Setup of purification chromatography and Qualification skids for pre-use, processing, and post-use activities. Carried out product purification through Affinity chromatography and Ion exchange chromatography (AEX/CEX), Viral inactivation and Depth Filtration processing, Setup of Single Use Mixer, Totes, and filters.
- Successfully Packed GMP Columns RFT, Resin Prep, columns clean, Set up and COP of slurry vessels, Clean Rinse and Swab Sampling to support Cleaning Validation.
- Equip prep Parts Washer Hose and Mixed parts loads for Downstream Processing, Filter integrity Testing on Vent and Processing filters.
- Performed weighing of powder and liquid dispenses for buffer/media makeup.
- Set up mobile and fixed totes for solution transfer out and Performed Remote and Local Buffer/Media transfer outs. Performed standardisation, Verification of pH/Conductivity meter and Sample Analysis of solutions.
Ovarian Cancer Biomarkers Research Project
Maynooth University
Maynooth, Ireland
10.2021 - 04.2022
- Conducted comprehensive literature reviews for project development. Assisted in design of research methodologies to improve data collection efficiency.
- Coordinated with team members, ensured smooth communication and workflow. Facilitated study group sessions to enhance understanding of research topics.
- Attended professional workshops to stay updated on latest industry trends and advancements. Examined thoroughly cells stained with dye to locate abnormalities.
- Stained and marked cellular changes and abnormalities with accuracy, analysed samples of biological material for chemical content or reaction, and analysed data using various statistical methods to obtain accurate results.
Pathology Department Intern
HSE, Our Lady's Hospital
Navan, Ireland
12.2017 - 09.2018
- Conducted in-depth analysis into various samples, including blood and tissue, to determine cause of patient's illness.
- Adhered to health and safety regulations when disposing chemicals and patient's blood samples waste. Stayed strictly in line with safety procedures when dealing with flammable liquids, infectious bacteria, and biohazards.
- Liaised extensively with laboratory departments to establish and maintain open communication that facilitated smooth operations.
- Accurately labelled samples for storage and testing, Followed strict protocols while blood banking to ensure safety for transfusions.
- Conducted regular deep cleaning and sterilisation on equipment before and after use, keeping in line with Health and Safety authority regulations.
- Kept in line with strict safety procedures to eliminate specimen contamination
- Accurately inputted test and clinical analysis results into system
- Prepared and stained microscopic specimens for analysis using Sysmex and ACLTOP analyser
- Conducted regular quality inspections on lab equipment through assessments and performance tests, ensuring equipment stayed in excellent and safe working order
- Managed preparation of specimens for analysis and observation by microbiologist to determine root cause of infections
Retail Store Assistant
Apple Green Petrol Station
Collon, Ireland
07.2017 - 12.2017
- Liaised with managers to determine daily tasks and priorities
- Assisted customers, employees, and managers with questions regarding stock, inventory, and supplies
- Observed customer behaviours to identify security threats and escalate concerns to supervisors
- Stayed up to date on store promotions, payment policies and security practices
- Replenished shelves frequently ensuring availability of products at all times.
Education
Bachelor of Science - Biomedical Sciences
Maynooth University
Maynooth Sept 2018 - Sept 2022
Post-Leaving Certificate - Clinical Laboratory Science
Cavan Institute
Cavan 09.2017 - 09.2018
Irish Leaving Certification - Science
St. Ciaran's Community School
Kells 08.2015 - 08.2017
Skills
- Manufacturing Operations
- Quality System
- Good Manufacturing Practice (GMP)
- Hazardous Materials
- Batch Record Review
- Communication
- Standard Operating Procedures
- Deviation Management
- Scientific Writing
- TFF Cytiva Single Use Skids
- Chromatography Skid Operations
- Affinity Chromatography
- Ion Exchange Chromatography
- Viral Inactivation
- Depth Filtration
- Viral Filtration
- Ultra-filtration
- Formulation, Final Fill and Freezing
- Column Packing and Unpacking
- HETP Evaluation
- CIP and COP of Vessels
- Solution Preparation and Transfer
- Equipment Preparation
- Sterile Manufacturing
- Protein Purification and Identification
- DeltaV
- MES PAS-X
- Eval
- Lims
- SAP
- OSI PI
- End-User Computing
- Process improvement
- Problem-solving
- Lean manufacturing principles
- Technical Support
- Operations Support
- Troubleshooting
- Biopharmaceutical
Accomplishments
- Maynooth University Gauss Prize 2020 - Best results in Standard Mathematics in the 2nd Science examinations
- Cricket Leinster Tillian Cup 2020
- KCC Player of the Year 2018
- KCC Batsman of the Year 2018
Awards:
Timeline
Manufacturing Biotech Associate
MSD Dunboyne Biologics
09.2022 - Current
Ovarian Cancer Biomarkers Research Project
Maynooth University
10.2021 - 04.2022
Bachelor of Science - Biomedical Sciences
Maynooth University
Sept 2018 - Sept 2022
Pathology Department Intern
HSE, Our Lady's Hospital
12.2017 - 09.2018
Post-Leaving Certificate - Clinical Laboratory Science
Cavan Institute
09.2017 - 09.2018
Retail Store Assistant
Apple Green Petrol Station
07.2017 - 12.2017
Irish Leaving Certification - Science
St. Ciaran's Community School
08.2015 - 08.2017
Sports
Knockharley Cricket club, Navan, Co. Meath, Represented club competitively in Division 3 Leinster League., Help in coaching junior and new members.
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