An independent pharmaceutical specialist.
“convert your parenteral problems into successes”
Biography
Career:
PJC Pharma Consulting Ltd April 2009 to present
Executive Director and Owner
GSK Pharmaceuticals (formerly SB, SKF) 5th August 1985 to Apr 2009
Director, Product Development, Aug 2007 to Apr 2009
Here I managed a team of twelve scientists (all PhD or MSc level) and ran numerous projects within Pharmaceutical Development. My role included resource allocation within the team to support the projects, budget and resource forecasting, career development / coaching / training for team members, maintenance of project plans and authoring of regulatory documents. I have much experience of Research and Development Project Team representation, Matrix Team Leadership and New Product Supply Chain Team representation. I have significant experience of product development from Candidate selection through to NDA/MAA submissions both for new chemical entities and product line extensions (PLEs). I have hosted FDA meetings, FDA pre-Approval inspections and MHRA inspections. I have many years of experience leading trans-national teams based in Japan, EU and USA for development of products for the Japan and Worldwide commercial markets. I led worldwide initiatives and scientific reviews. I was responsible for the worldwide development of ADME studies and supplies, including study designs, formulation development and logistics, worldwide auditing. I led teams tasked with developing formulations that target specific physiological targets both in man and in pre-clinical species.
Head, UK Sterile Product Manufacturing, Clinical Trial Supplies. Jan 2006 to Aug 2007
In this role I led a department of scientists (BSc level scientists) whose role was to supply the GSK development pipeline needs from Phase 1 to Phase 3, including technical transfer to the factory network worldwide. I was accountable for the provision of parenteral clinical trial supplies for worldwide studies for EU based compounds. I was tasked with restructuring the group and trouble-shooting. This included coaching and mentoring the staff, facility qualification, in-depth process reviews and, where appropriate, organising remedial plans and subsequent actions. I developed investment plans and liaised with development departments to ensure alignment of the facility and the requirements of the worldwide business. I detailed microbiology re-qualification plans for area classifications and air sampling. I presented to senior management the plans for the facility to ensure budgetary approval and endorsement.
Manager, Product Development, 1994 to January 2006
My responsibilities were as per those described for my more recent position of Director, Product Development.
Pharmaceutical Development 5th August 1985 to 1994
I held various technical positions within SB/SKF including Team Member, Senior Scientist and Scientist.
Education and Qualifications
University of Hertfordshire, Hatfield, Herts
DipHE Applied Biology 1990
BSc (Hons) Applied Biology (Human Phys/Pharm) 1992
Professional Qualifications
A Chartered Biologist and Full Member of the Society of Biology (CBiol, MSB).
An active member of the Parenteral Drug Association
A Registered European Professional Biologist (EurProBiol)
Home
PJC Pharma Consulting Ltd April 2009 to present
Executive Director and Owner
GSK Pharmaceuticals (formerly SB, SKF) 5th August 1985 to Apr 2009
Director, Product Development, Aug 2007 to Apr 2009
Here I managed a team of twelve scientists (all PhD or MSc level) and ran numerous projects within Pharmaceutical Development. My role included resource allocation within the team to support the projects, budget and resource forecasting, career development / coaching / training for team members, maintenance of project plans and authoring of regulatory documents. I have much experience of Research and Development Project Team representation, Matrix Team Leadership and New Product Supply Chain Team representation. I have significant experience of product development from Candidate selection through to NDA/MAA submissions both for new chemical entities and product line extensions (PLEs). I have hosted FDA meetings, FDA pre-Approval inspections and MHRA inspections. I have many years of experience leading trans-national teams based in Japan, EU and USA for development of products for the Japan and Worldwide commercial markets. I led worldwide initiatives and scientific reviews. I was responsible for the worldwide development of ADME studies and supplies, including study designs, formulation development and logistics, worldwide auditing. I led teams tasked with developing formulations that target specific physiological targets both in man and in pre-clinical species.
Head, UK Sterile Product Manufacturing, Clinical Trial Supplies. Jan 2006 to Aug 2007
In this role I led a department of scientists (BSc level scientists) whose role was to supply the GSK development pipeline needs from Phase 1 to Phase 3, including technical transfer to the factory network worldwide. I was accountable for the provision of parenteral clinical trial supplies for worldwide studies for EU based compounds. I was tasked with restructuring the group and trouble-shooting. This included coaching and mentoring the staff, facility qualification, in-depth process reviews and, where appropriate, organising remedial plans and subsequent actions. I developed investment plans and liaised with development departments to ensure alignment of the facility and the requirements of the worldwide business. I detailed microbiology re-qualification plans for area classifications and air sampling. I presented to senior management the plans for the facility to ensure budgetary approval and endorsement.
Manager, Product Development, 1994 to January 2006
My responsibilities were as per those described for my more recent position of Director, Product Development.
Pharmaceutical Development 5th August 1985 to 1994
I held various technical positions within SB/SKF including Team Member, Senior Scientist and Scientist.
Education and Qualifications
University of Hertfordshire, Hatfield, Herts
DipHE Applied Biology 1990
BSc (Hons) Applied Biology (Human Phys/Pharm) 1992
Professional Qualifications
A Chartered Biologist and Full Member of the Society of Biology (CBiol, MSB).
An active member of the Parenteral Drug Association
A Registered European Professional Biologist (EurProBiol)
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