Personal Profile

An enthusiastic and self-motivated Analytical and Regulatory CMC Scientist with 20 years experience in the pharmaceutical industry, offering strong communication, presentation and interpersonal skills. Significant experience with FDA, CDER, EMA and ICH Q(Quality) and S(Safety) guidance’s and an excellent appreciation of cGMP and cGLP. Key strengths include an ability to liaise effectively at all levels within and across all levels internally and externally, self-motivated and well organised with a proven ability to work as an effective team leader and team member.

Professional Experience

Pfizer Ltd; Sandwich 1991- to date

Analytical Team Leader (Late Stage Portfolio) (2009-Current)

Analytical Team Leader at Pfizer Ltd, Sandwich, UK.

Key Achievements:

• Following the Pfizer merger with Wyeth, responsible for the analytical and regulatory CMC activities for three Phase III products in the oncology and infectious disease therapeutic areas.

• Responsible for leading a diverse team of nine analytical colleagues. Effectively trained and mentored team members in analytical techniques and drug development approaches, whilst encouraging them to broaden their knowledge and skill sets to maximise their performance within the department.

• Successfully integrated legacy Wyeth programs into Pfizer and delivered all projects to aggressive technical and regulatory filing milestones to agreed budgets.

• Accountable for the authorship and approval of Common Technical Dossiers (CTD) for global registration including Japan and Emerging Markets e.g. Bosulif(R).

• Responsible for the development and implementation of new analytical and regulatory paradigms during drug development e.g. Quality By Design for Analytical Methods, Real Time Release testing

• Assumed additional responsibility for the management of the technical, business and quality oversight of the Global Registration Stability group. This group supported the testing and reporting of ICH API, drug product and device related stability programs including authorship of regulatory stability reports, oversight of budgets and resources, management of vendor quality and resolution of technical issues.

• In support of outsourcing activities in Asia, led the development and scale-up of two Product Enhancement products with an Indian vendor. The scope of the work ranged from project initiation, through formulation and process development to scale-up of ICH supplies and registration stability. Continually looked to identify opportunities for more effective communication, cost savings and resolution of technical and quality related issues, whilst supporting and advising the External Outsourcing group in negotiations with vendors.

• Analytical Lead for Due Diligence activities working in close partnership with Worldwide Business Development. Responsible for the technical and regulatory review of the CMC components of product dossiers and preparation of detailed technical and risk assessment reports.

Chemical Process Research and Development API Team Leader (2008 – 2009)

Team Leader at Pfizer Ltd, Sandwich, UK.

Key Achievements:

• As part of personal growth and development, assumed a team leader position in Chemical Process Research and Development on a 12 month secondment.

• Led a team of eight chemists supporting the development of cost-effective, robust and efficient API manufacturing processes.

• Responsible for the development of new synthetic routes to a commercially approved product and developing regulatory CMC strategy for post-approval changes in global markets.

• Led the identification and implementation of new analytical approaches and technologies to support API process design and process development. Examples include early adoption of PAT for process understanding, use of alternate chromatographic detectors to map impurity profiles, high resolution mass spectrometry for impurity identification.

Analytical API Team Leader (Late Stage API Portfolio) (2006 – 2008)

Analytical Team Leader at Pfizer Ltd, Sandwich, UK.

Key Achievements:

• Following a change in organisational structure, I assumed responsibility for a team of twelve analysts supporting the late stage (Phase IIb to commercial registration) API portfolio.

• Successfully supported the design and development of the analytical and regulatory CMC strategy for API manufacturing processes from the manufacture of clinical and toxicological supplies through to the development and transfer of commercial processes following Quality By Design principles.

• Accountable for rapid adoption and implementation of new API technologies (e.g. continuous flow chemistry).

• Led a global cross-functional line team that developed streamlined and harmonised workflows for the development of commercial API manufacturing processes including implementation of Quality by Design philosophies.

• Authored templates for the API analytical sections of regulatory submissions (Sections 3.2.S.1 to 3.2.S.7).

• In addition to primary API responsibilities, authored and approved analytical and regulatory CMC dossiers for two Animal Health commercial products (Cerenia and Palladia).

• Supported the development of a new injector pen for an established growth hormone project from device design to prototype manufacture.

Analytical Team Leader (Late Stage Portfolio) (2002 – 2006)

Analytical Team Leader at Pfizer Ltd, Sandwich, UK.

Key Achievements:

• Following the Pfizer merger with Pharmacia, responsible for the analytical and regulatory CMC activities for three Phase III products in the oncology and pain therapeutic areas.

• Responsible for the management of a team of analytical scientists at a Contract Research Organisations (CRO) in Italy including operational, contractual and budgetary needs.

• Successfully integrated legacy Pharmacia projects into Pfizer and delivered all projects to aggressive technical and regulatory filing milestones to agreed budgets.

• Successfully supported the design and development of the analytical and regulatory CMC strategy for commercial API and drug product (solid oral, liquids, parenenterals) manufacturing processes following Quality By Design principles

• Accountable for defining the analytical and regulatory CMC strategy for each project and ensuring effective use of resources and technology to complete key development milestones, including manufacture and release of API and drug products for Phase III and commercial supplies.

• Accountable for the authorship and approval of regulatory CMC IND and IMPD submissions for global clinical studies.

• Accountable for the authorship and approval of Common Technical Dossiers (CTD) for global registration including Japan and Emerging Markets e.g. Sutent(R).

• Responsible for the preparation of Briefing Documents and leading the strategic analytical focused discussions with Regulatory Agencies (e.g. FDA, CHMP) at End of Phase II, pre-NDA and Scientific Advice meetings.

• Successful in leading the technology transfer of API and drug product manufacturing processes and analytical methodology to commercial manufacturing sites in Ireland and Italy.

• Supported Pre-Approval Inspections (PAI) of commercial manufacturing sites in by FDA and PMDA and Korean inspectors.

Analytical Team Leader (Sexual Health Group) (1999 – 2002)

Analytical Team Leader at Pfizer Ltd, Sandwich, UK.

Key Achievements:

• Responsible for the analytical activities supporting development of multiple drug development candidates in the Sexual Health and Urology therapeutic area, spanning First In Man (FIM) to Phase III clinical studies.

• Responsible for the management of a team of ten people including mentorship and performance management.

• Accountable for defining the analytical and regulatory CMC strategy for each project and ensuring effective use of resources and technology to complete key development milestones, including manufacture and release of API and drug products for clinical, toxicological and stability supplies.

• Accountable for the authorship and approval of regulatory CMC submissions including IND/IMPD dossiers. This also included the preparation and approval of regulatory responses raised by FDA, EMA and other Boards of Health (BOH). Successfully filed and gained approval for >50 CMC dossiers during this period.

• Primary author of the analytical and CMC sections of the Caduet(R) NDA and MAA filing.

Analytical Chemist (1991 – 1999)

Member of a drug development project team at Pfizer Ltd, Sandwich, UK.

Key Responsibilities:

• Analytical testing support of API and solid and liquid oral dosage forms manufactured for the clinical and commercial supply chain.

• Primary responsibilities were process development support for API and formulation studies, method development (assay, impurities, dissolution), validation, stability and clinical release testing.

• Techniques utilised were predominantly reverse phase and normal phase HPLC, GC, dissolution (USP Apparatus I and II) and pharmacopoeial methodology.

• Primary author of the analytical and CMC sections of the Tikosyn(R) NDA and MAA filing.

• Supported the technology transfer of API and drug product technology to the commercial manufacturing sites.

• Supported Pre-Approval Inspections (PAI) of commercial manufacturing sites in Ireland, USA and Puerto Rico.

• Participated in project review meetings with internal colleagues from other departments.

• The role involving a high degree of laboratory skills and organisation, good attention to detail, a working awareness of cGMP and cGLP and I was able to work independently and liaise directly with colleagues in Sandwich and at other Pfizer European and US sites.

Quality Control Chemist (1988 – 1991)

Quality Control analyst for Parke-Davis Healthcare (three year summer vacation position)

Key Responsibilities:

• Provided analytical support for the manufacturing division with the release and stability testing of raw materials and finished API and drug products. Main products tested were Benylin, Listerine, Gemfibrozil and Abidec Vitamin Drops.

COURSES ATTENDED

Available on request

EDUCATION

First Class Honours Degree in Chemical and Analytical Science

University of Wales, Swansea (1988 to 1991)

Awarded the R H Davies Prize in the first year for the highest overall grades.

3 A levels (Grades A –E) and 11 O Levels (Grades A-C)

Fairwater Comprehensive School, South Wales (1988)

EXTERNAL PAPERS AND PRESENTATIONS

Influence of frictional heating on temperature gradients in ultra-high-pressure liquid chromatography on 2.1 mm I.D. columns Original Research Article

Journal of Chromatography A, Volume 1113, Issues 1-2, 28 April 2006, Pages 84-91

André de Villiers, Henk Lauer, Roman Szucs, Stuart Goodall, Pat Sandra

Chemical and Pharmaceutical Requirements III: Control of Starting Materials, European Continuing Education College (2008 - current)

Late Stage Approach to Purposeful Degradation and Review of Data To Be Included in The Common Technical Dossier (CTD) – 3rd Annual Conference on Forced Degradation, January 2009, Brussels

Real Time Release – Overview and Case Studies . PASG Summer Meeting May 2010.

A Science and Safety Based Risk Assessment Framework for Enzyme Related Residues in Small Molecule API Synthesis – Impurities 2010, Berlin (September 2010) and AICHE, Salt Lake City (November 2010)

INTERESTS AND GENERAL INFORMATION

I am an avid follower of rugby and Welsh rugby in particular and finally retired for playing five years ago. My other interests include clay pigeon shooting, James Bond films and reading biographies. My current employment demands high levels of integrity, efficiency and commitment. The requirement to work under pressure has given me the ability to prioritise and organise my activities, whilst maintaining and awareness of the needs of the projects, my team members and key line and external stakeholders. I consider myself to be open and approachable with a strong commitment to the people I work with and supervise.

REFERENCES

Available on request.

Contact this candidate