Manufacturing Operations Continuous Improvement

HAMIDA HAROON

Lexington, MA *****

Phone: 781-***-**** Email: ****************@*****.***

PROFESSIONAL EXPERIENCE

Thermo Fisher Scientific Feb 2021 – Mar 2025

Plainville, MA – Lead Formulation Technician, Downstream Manufacturing

Executed downstream manufacturing operations within Viral Vector Services under cGMP standards

Executed downstream manufacturing operations including AKTA chromatography, RS50, KR2i/KMPi (TFF systems), FIT, GPT, and API purification processes such as clarification, chromatography, and filtration, Ultrafiltration.

Utilized laboratory Instrumentation: standardized pH meters, Conductivity meter.

Performed Biological Safety Cabinet (BSC) operations in compliance with cGMP standards, ensuring consistent BSC readiness.

Prepared and processed formulations following SOPs and aseptic techniques to maintain product integrity.

Operated production equipment to support the manufacture of both clinical and commercial products.

Maintained strict adherence to ALCOA principles; accurately completed batch records, logbooks, and forms, and supported updates to SOPs and batch documentation.

Facilitated daily Tier meetings and drove continuous improvement initiatives using GMP Kanban systems and 5S methodology.

Trained new and existing team members on aseptic techniques, MES systems, and cleanroom equipment operations.

Performed aseptic activities, conducted visual vial inspections, and operated specialized equipment such as Biowelder, Watson Marlow pumps, and Repligen filtration systems.

Promptly reported deviations and discrepancies; supported deviation intake and documentation processes.

Partnered with Automation Engineering to conduct audit trail analysis using PAMS data, ensuring data integrity and regulatory compliance across multiple facilities.

Proficient in enterprise systems including SAP, Blue Mountain (BMRAM), and TrackWise.

Cambridge, MA – Lead Formulation Technician

Conducted cGMP upstream manufacturing at Cambridge and Lexington sites.

Operated production equipment following SOPs for both clinical and commercial product batches.

Documented activities in batch records, logbooks, and forms.

Followed verbal and written instructions to operate equipment and complete processing steps accurately.

Handled equipment preparation, sanitation, and disinfection.

Ensured aseptic techniques in formulation preparation.

Conducted BSC operations and maintained readiness.

Complied with protocols, batch records, SOPs, and work instructions.

Capable of aseptic and sterile gowning procedures.

Proficient in BMRAM, SAP, TrackWise, Vi-Cell, and other laboratory equipment.

Lexington, MA – Sr. Formulation Technician

Performed seed train, bioreactor, transfection, and clarification activities.

Prepared and processed formulations per SOPs using aseptic techniques.

Conducted BSC operations and maintained readiness.

Executed pipetting, pouring, seeding, and harvesting of adherent cell lines in tissue flasks and cell stacks.

Prepared growth and production media; performed critical upstream activities using iCELLis bioreactor platforms.

Monitored processes using automated systems with minimal supervision.

Skilled in BMRAM, SAP, and TrackWise.

Demonstrated mechanical troubleshooting skills.

Collaborated with cross-functional teams (Facilities, Engineering, Contamination Control, MST, QC, QA).

Sun Pharma, Billerica, MA May 2020 – Feb 2021

Formulation & Fill Technician I

Formulated and dispensed products in a cleanroom environment for radiopharma and dermatological applications.

Washed and sterilized equipment, filters, vials, ampoules, and other materials.

Conducted both manual and automated manufacturing processes.

Set up and prepared glassware and lab equipment.

Documented and reviewed batch records to ensure adherence to specifications.

Assisted in reviewing SOPs and batch records.

Ocular Therapeutix, Inc., Billerica, MA Aug 2019 – Nov 2019

Manufacturing Operator II

Performed all stages of product manufacturing including clinical and commercial builds.

Formulated ingredients, performed calculations, and conducted product build processes.

Calibrated pH meters and balances.

Conducted peel strength testing as needed.

Kaleido Biosciences, Billerica, MA Sep 2018 – Aug 2019

Pilot Lab Technician II

Conducted synthesis, purification, and evaporation processes in the pilot lab.

Operated kilo-scale chemical reaction systems and filtration systems.

Performed large-scale HPLC ion exchange chromatography and rotary evaporator operations.

Drafted SOPs and batch records.

Supported process development, trial batches, sampling, Brix testing, and data submission.

Maintained and sanitized equipment per SOPs.

Bio-Rad Laboratories, Billerica, MA Dec 2014 – Jul 2018

Manufacturing Associate II

Prepared primer plates and conducted BSC operations.

Performed formulation activities using aseptic techniques.

Conducted line clearance and verification.

Managed droplet primer library production and testing.

Manufactured and packaged reagents and oils.

Performed preventative equipment maintenance and supported validation activities.

Allergan Medical Systems, Medford, MA May 2013 – Dec 2014

Technician

Performed manufacturing activities, including monitoring equipment and documentation.

Ensured procedural compliance and documentation accuracy.

Prepared and verified equipment for production.

Conducted textile-related manufacturing operations including twisting, knitting, and finishing.

Operated and maintained cleanroom equipment under GMPs.

OPK Biotech, LLC, Cambridge, MA Apr 2012 – Mar 2013

Technician

Carried out purification and filtration in large-scale HPLC operations.

Conducted inspections of raw materials and equipment.

Operated under SOPs and GMPs in cleanroom settings.

Assisted with SOP writing and revisions.

Executed CIP/SIP and COP procedures.

Maintained production documentation and batch records.

Formulated buffers and performed filter integrity testing.

Conducted caustic storage and recirculation procedures.

Participated in in-process testing to ensure quality standards.

Pfizer Pharmaceuticals, Andover, MA Jun 2006 – Jun 2011

Technician

Managed media and buffer preparation in production support.

Supported fermentation and purification suites.

Conducted product sampling and quality testing.

Prepared peptone and glucose solutions.

Inspected raw materials and equipment.

Utilized instrumentation including pH meters, osmometers, and spectrophotometers.

Followed cGMPs and SOPs, including wet sterilization and CIP/SIP processes.

Maintained electronic batch records and reviewed documentation for GDP compliance.

EDUCATION AND CERTIFICATIONS

Bunker Hill Community College / Just-A-Start Corporation, Cambridge, MA 2006

Cambridge Biomedical Careers Program – Certificate in Biomedical Sciences

University of Dhaka, Bangladesh

Bachelor’s Degree

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