Mark Gallagher Email & Phone Number

Stockholm County, Sweden

Solna, Stockholm County, Sweden

Senior Scientist R&D Analytics biosimilars

United Kingdom

Senior Scientist Biologics-Product Development involving the reformulation of market available biopharmaceuticals to meet specific patient needs using the Arestat platform technology.During my time at Arecor I was heavily involved in study design and execution to support the production of reformulated insulin products for use in clinical trial as well as line management of junior colleagues through these activities. I was also involved in leading laboratory process development through… Show more Senior Scientist Biologics-Product Development involving the reformulation of market available biopharmaceuticals to meet specific patient needs using the Arestat platform technology.During my time at Arecor I was heavily involved in study design and execution to support the production of reformulated insulin products for use in clinical trial as well as line management of junior colleagues through these activities. I was also involved in leading laboratory process development through the implementation of fit for purpose quality practices to improve traceability across the company as it approached late stage product development.Key outputs;•Line managment of analytical staff•Analytical study design•Analytical study execution •Implementation of ALCOA, RCA, project visualisation and other quality tools•Definition of lab workflows to optimise data generation •Purchase and procurement of equipment and raw materials•Involved in personnel hiring process•Sourcing and organising third party analytical testing Show less

Slough, United Kingdom

In my role at Lonza I was part of an expert team responsible for protein characterisation. The group sits downstream of Lonzas manufacturing process that supports batch release of clinical trial and commercial material, BLA and IND submission as well as complex bespoke structural analysis in alignment with cGMP and ICH guidelines. The group was uniquely placed in a cross sectional area between manufacturing, R&D, QC, regulatory and our customers. As a result this afforded me the opportunity to… Show more In my role at Lonza I was part of an expert team responsible for protein characterisation. The group sits downstream of Lonzas manufacturing process that supports batch release of clinical trial and commercial material, BLA and IND submission as well as complex bespoke structural analysis in alignment with cGMP and ICH guidelines. The group was uniquely placed in a cross sectional area between manufacturing, R&D, QC, regulatory and our customers. As a result this afforded me the opportunity to be exposed to many facets of the business from optimising assays for new products all the way up to top level discussion with the customer. Having come from academia there was a sharp learning curve which I thoroughly enjoyed and ultimately fused my scientific expertise with a strong skill set in multidisciplinary people engagement, customer driven dedication and business focused time line management. Key responsibilities + Study Lead + HPLC system owner and SME+ Deviation and CAPA writing+ Operating to cGMP standards+ Protein characterisation to support IND and BLA filling+ Primary to high level protein structural analysis including oligosaccharide profiling(SEC HPLC, SEC MALS, Oligos LC, Oligos MS, CD, AUC, Sialics, Free thiol, PMAP MS, Intact mass MS, Di-sulphide MS, Western blot) Show less

School Of Human Sciences, Lmu, 166-220, Holloway Rd., London, U.K.

Extracellular vesicles (EVs) represent an integral cellular communication mechanism. While their existence has been known for several decades EVs have only recently been implicated in many pathological and normal cellular functions. Specific DNA, RNA and protein components carried by EVs cause these functional effects.This research aims to identify the contents of stem cell derived EVs which have been shown to prevent various types of acute kidney injury. As stem cells are difficult to… Show more Extracellular vesicles (EVs) represent an integral cellular communication mechanism. While their existence has been known for several decades EVs have only recently been implicated in many pathological and normal cellular functions. Specific DNA, RNA and protein components carried by EVs cause these functional effects.This research aims to identify the contents of stem cell derived EVs which have been shown to prevent various types of acute kidney injury. As stem cells are difficult to produce in therapeutically relevant quantities the overall aim of this research is to produce large scale bioprocess produced synthetic EVs which will include the contents identified from stem cell derived EVs. This will provide a therapeutic solution utilising the clinically significant effect observed in acute kidney injury treatment with stem cell EVs. Show less

Dublin City University, Dublin, Ireland

Proteomic profiling of Chinese hamster ovary cells with industrially desirable phenotypes using label free mass spectrometry. An additional separate study involved the identification of novel proteins as potential antibody drug conjugate targets in breast cancer.

Limerick, Ireland

Dairy product quality control with standard micro-organism testing coliforms, E. coli, S. aureus etc.

Duties included the following;- Batch testing dairy products from local farms- Industrial baby food formula testing (Wyeth) - Testing of health inspection samples- Water quality testsResponsibilities associated with the above duties included; - Confirmation and enumeration tests for microorganisms in food samples and water- Media preparation employing aseptic technique- Data reporting through ISO9000 quality management documentation- Sample… Show more Duties included the following;- Batch testing dairy products from local farms- Industrial baby food formula testing (Wyeth) - Testing of health inspection samples- Water quality testsResponsibilities associated with the above duties included; - Confirmation and enumeration tests for microorganisms in food samples and water- Media preparation employing aseptic technique- Data reporting through ISO9000 quality management documentation- Sample handling and associated documentation processing- Operation within strict sampling plans- Daily instrumentation calibration checks Show less

Phd Cell Biology, Cell/Cellular And Molecular Biology

In 2009 I was awarded IRCSET funding. PhD research was successfully defended on March 2nd 2016 and currently being corrected.

Bio-Analysis And Biotechnology, Bio-Analysis And Biotechnology

I enrolled in the Applied Biology course in Limerick Institute of Technology in 2009 and graduated in 2009 with a Certificate in Applied.