About BioChem QP Consulting

About BioChem QP Consulting BioChem QP Consulting is a fully independent, VAT registered, privately held company, registered in Scotland and owned by Mark Slattery who delivers all Qualified Person services provided through the company. Here are a few details of our experience and client engagements to date, as well as a selection of Mark’s specific interests and areas of expertise, that might help differentiate BioChem QP Consulting from the many other excellent contract QP services out there today…

Facility experience

I have direct, first hand experience of acting as QP at MIA, MIA(IMP), and MS sites, including IMP QP oversight for UK. I’ve set up PQS for QP Importation facilities from scratch in both UK and Ireland, obtaining regulatory licences and importing products from tablets to ATMPs. I’ve worked through the commercialisation of mutiple products, including live viral vaccines and CRISPR-Cas9 ATMPs, facilitating MHRA & FDA PAI inspections, including response and CAPA plans

Product Experience - including ATMPs

I’ve worked for a global client base (especially US / EU / UK), from big pharma to small CMOs and virtual biotech startups - with products ranging from tablets and capsules to ATMPs, cell banks (CHO for mAbs), virus seeds, live virus vaccines, COVID vaccines, cell and gene therapies including hESCs. T-cells, CAR-T, and CRISPR Cas-9 editing, and viral vectors including HSV and lentivirus.

Analytical QC

I started in GMP within the QC lab. I’m an MSc Qualified Analytical Chemist, spending several years in the API QC labs at Zeneca. In addition to chemical QC expertise (chromatography, spectroscopy, etc), I have over 20 years experience with biological QC testing, including molecular biology techniques, immunology-based testing, virology, and microbiological QC testing, as well as specific ATMP techniques including cell-based potency assays, genetic sequencing, and flow cytometry.

Maths and Stats

Any of my clients will confirm how much I love looking at an SPC or trend chart, on pretty much any topic. I’m well-versed in Excel, and other more capable statistical software including Minitab and SPC for Excel. I have an enduring interest in the application of statistics (good and bad) to aspects of process control, QMS performance, sampling, analytical and process validation, and anything else I can find a use for. If you can’t measure it you can’t hope to control it!

Continuous Learning and Development

One of the best things about being a Contract QP is that you get to set your own training budget! Since 2010 I’ve attended multiple training / CPD events every year - including on aseptic processing (shout out to PHSS), PQG events, MHRA & HPRA symposia, Pharma Law updates, ATMPs, AI in Pharma, etc. During that time I’ve also completed an OU Honours Module in Cell & Molecular Biology, and a Masters diploma in ATMPs from the University of Granada (2024)

IT and Software Capabilities

I never rely solely on my client companies to provide me with the hardware and software I need to do a good job. I have my own IT equipment with full Office365 suite (OneDrive, Teams, etc), as well as my own subscriptions to both USP and EP - essential for any contract QP. I also have Visio (can’t beat a good process map), MindManager for mind-mapping (still the best way to organise thoughts), and timesheet software for clear detailed invoices

Time for a few more

beaches?

There’s always time for a good Lochaber beach pic. Working in our industry can be challenging, with multiple competing priorities and lots of dificult decisions to be made… so it’s important every now and then to step off the treadmill and breathe some fresh air. Many of my good ideas or insights come when I’m away from the desk, so if you don’t fancy using the contact details below, maybe I’ll just see you down at the beach!