Experience

Hare Analytical Ltd

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director

  • Dec 2020 - Present

  Hare Analytical Ltd - Offering QA consultation Hare Analytical Ltd - Offering QA consultation



bit.bio

• United Kingdom
• Biotechnology Research
• 100 - 200 Employee

• QA Manager

  • Mar 2021 - Feb 2022



Freeline

• United Kingdom
• Biotechnology Research
• 1 - 100 Employee

• Director Of Quality

  • Oct 2019 - Dec 2020



Adaptimmune

• United Kingdom
• Biotechnology Research
• 300 - 400 Employee

• QA Manager

  • May 2018 - Oct 2019

  QA Manager at Adaptimmune QA Manager at Adaptimmune



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Advisor Cell and Gene Therapy

  • Dec 2016 - May 2018

  Conduct initial and period qualification on equipment that is ensuring that the equipment is suitable for used in GMP manufacture. Have taken the QA lead in setting up the QC GMP lab. I also lead audit / assessment (internally and externally) to ensure GxP standards are being applied to maintain Quality management standards, supply, manufacture and testing of material (associated with Cell and Gene Therapy, provision of services provide to R&D and manufacture and associated qualification conducted by manufacturers to equipment is suitable for GxP manufacture. Another aspect of my roles is to coordinate and facilitate the processes that are used with respect to supplier / vendors to ensure appropriate approval to enable the appropriate quality standards are applied to the RM, Int, GUMs (general use material) to allow GMP manufacture to progress.I also lead projects and matrix teams throughout my time in QA, this has enabled me to developed the appropriate strategies, skills and understanding of resources allocation that is required to successfully complete projects effectively and on time. I have attained my Lean Sigma Green Belt qualification and actively seek continuous improvement initiatives, both within QA and within the other R&D groups to help make them more efficient and effective. I have been instrumental in developing the strategy, deployment and co-ordination of trainers to roll out the Six Sigma Yellow Belt training across R&D. I have develop the skills required to become a coach and mentor to help identify the required development needs for staff both within QA and the rest R&D to ensure that they are efficient and effective in what they are undertaking. I have also started to coach and mentor staffs in R&D on the use and implementation of continuous improvement tools to further enhance the benefits to the organization.

• Senior QA advisor

  • Oct 2005 - Dec 2016

  Control the release API across clinical trials at all phases of development. Conduct initial and period qualification on equipment that is ensuring that the equipment is suitable for used in GMP manufacture. I also lead audit / assessment (internally and externally) to ensure GxP standards are being applied to maintain Quality management standards, supply, manufacture and testing of material (RM, SM Int), provision of services provide to R&D and manufacture and associated qualification conducted by manufacturers to equipment is suitable for GxP manufacture. Another aspect of my roles is to coordinate and facilitate the processes that are used with respect to supplier / vendors to ensure appropriate approval to enable the appropriate quality standards are applied to the RM, Int, GUMs (general use material) to allow GMP manufacture to progress.I also lead projects and matrix teams throughout my time in QA, this has enabled me to developed the appropriate strategies, skills and understanding of resources allocation that is required to successfully complete projects effectively and on time. I have attained my Lean Sigma Green Belt qualification and actively seek continuous improvement initiatives, both within QA and within the other R&D groups to help make them more efficient and effective. I have been instrumental in developing the strategy, deployment and co-ordination of trainers to roll out the Six Sigma Yellow Belt training across R&D. I am now undertaking training to achieve my Six Sigma Black Belt.Over the past 18 months I have started to develop the skills required to become a coach and mentor to help identify the required development needs for staff both within QA and the rest R&D to ensure that they are efficient and effective in what they are undertaking. I have also started to coach and mentor staffs in R&D on the use and implementation of continuous improvement tools to further enhance the benefits to the organization.



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior QA Advisor

  • Nov 2003 - Oct 2005

  Responsible for the training, development and annual review of 2 staff members that reported directly to me. As part of this I had to create the appropriate training and development plans to ensure that they were effective members within QA.One main aspect of my role was the review of commercial batch records and associated analytical testing to ensure that the material was “fit for purpose” for commercial use. I was also responsible for the release of non API (intermediates and starting materials) for the site.Responsible for the writing, execution and write up of all qualification and validation work that took place on the site. This ranged from the qualification of HPLC systems to the validation of the equipment that was used for commercial manufacture.I also performed the role of a Lead auditor for internal QMS audits and additionally a lead auditor for external supplier audits to ensure that the ISO 9000 standards are being applied to suppliers that were used by the site for API manufacture.

• QA advisor

  • Mar 2001 - Nov 2003

  Review of API batch records and associated analytical data to enable batch release to occur.Conducted as Lead auditor internal and external audits to ISO 9000 standards.Responsible for completion of the site annual product report.Actively involved in the process of qualification and validation of new and existing equipment using in the GMP manufacturing and testing facilities.

• Process Chemist

  • Aug 1999 - Mar 2001

  I worked in a small scale lab, manufacturing to APIs to cGMP standards, I was responsible for a team of 5 staff members. This included assigning work to ensure that the products were manufactured on time and to the correct standards. I was also responsible for the training, development and annual reviews for all my team members.I also assisted the plant manager with the forecast and schedules for the small scale labs.