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nabiha hussain

nabiha hussain

GMP Production Scientist II

Healthcare

Marston Moretaine, Central Bedfordshire

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About nabiha hussain:

My experience includes managing the production of a small-scale product at Kings and Advent Bioservices, where I was exposed to all roles required to prepare, manufacture and release an ATMP under a specials licence. At King’s I was working as a team of 3, I was manufacturing alongside my production manager and completing day to day tasks with the senior scientist. This meant I had to be well versed in all that was required from management to push the drug product to completion and was completing tasks beyond my job description. Having fulfilled an MLA, QC Scientist, Production Scientist and QA role prior to joining Advent I know I have a lot to bring to the table. 

Experience

  • Senior member of the team leading GMP manufacture of a drug product under a specials licence. 
  • In depth knowledge of QMS, implementing controlled changes, risk assessing processes and executing CA/PA plans.
  • Leading the validation of a new cleanroom facility, from writing validation protocols to conducting qualification of equipment.

 

 

 

 

  • Training and assessing the production team and QC staff on cleanroom competency and reviewing training plans. 

 

  • Preparing documentation for MIA licence applications and MHRA audits. 

 

  • Constructing gowning, transfer of items and environmental monitoring procedures, writing policies, SOPs and forms to support these processes. 

 

 

 

  • Designing and implementing aseptic processes for tech transfer to new cleanroom facilities.

 

  • QC testing for release as per specifications. Using flow cytometry, protein assays and controlled documentation. 

 

  • Designing consumables to aid in implementing closed systems for use in manufacture. Setting up contracts with external suppliers to allow for tailor made consumables. 
  • Performing validation tasks and obtaining data required to qualify cleanrooms for MHRA compliance.

 

  • Cryopreservation of dendritic cell drug product. Labelling, packaging and storage of drug products and samples. 

 

  • Attending conferences and events to showcase Advent services and advertise hiring opportunities. 

 

 

Education

 Imperial College London – 6-month thesis research project Feb 2016 – Oct 2016

 

Thesis: “Role of Arkadia and Smad7 in Regulating and establishing threshold in Nodal-Smad2/3 Signalling”

 

Exploring TGF-β signalling regulatory components through gene editing using CRISPR/Cas9 technology in mouse embryonic fibroblasts. Generating cell line of CRISPR clones and investigating involvement of these components in establishing thresholds in embryonic development.

 

  • Nucleofection, Primer design, CRISPR/Cas9
  • ARMS-PCR, qPCR,

 

  • SDS-PAGE Western Blot, Immunohistochemistry
  • Mammalian cell culture (MCF-7, MEFs), microscopic & florescent analysis, cell counting
  • Subcloning, DNA isolation with Mini Prep, recombinant protein expression
  • Protein isolation and purification, ELISA, mouse embryo dissections, genotyping
  • Transcriptional activity assays (Luciferase activity)

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