Leo Singh Barker
Devizes,Wiltshire
Summary
Dynamic scientific professional specialising in QA and QC functions, with over 15 years of experience excelling in a wide range of technical scientific disciplines, focusing on pharmaceutical products. In-depth understanding of regulatory compliance and quality assurance. Adept at leading teams and driving process validation, I leverage analytical techniques to enhance product quality. My strong problem-solving skills and attention to detail ensure adherence to GxP standards, fostering continuous improvement in laboratory operations.
Overview
17
17
years of professional experience
Work History
Quality Control Manager
GlassPharms
06.2024 - Current
- Act as lead/technical management for QA/QC function of the business
- Responsible for release of medicinal products according to GMP and GACP guidelines
- Responsible for creation and maintaining adherence to GxP standards as per internal quality system
- Assigning tasks, coaching and mentoring
- Management and due diligence of external laboratory partners and analytical consultants.
- Management of laboratory team KPIs and budget
- Development of analytical methodology
Senior/Lead Scientist
Vectura Fertin Pharma
01.2022 - 04.2024
- Act as technical expert and lead problem solving for a wide range of laboratory/ process activities
- Able to solve complex technical problems in field of expertise applying a high level of technical knowledge
- Lead complex protocols from line management with minimal supervision, able to derive solutions using different techniques and experience from different work areas
- Accountable for complying with role specific training requirements, H&S and GMP process.
- Able to check data thoroughly in compliance with Quality standards and present deep analyses on data, including complex statistical analysis and interpretation.
Study Director
CEM Analytical Services
01.2018 - 12.2021
- Project management; liaising with clients, colleagues and external principal investigators
- Working closely with section managers and analytical staff to ensure project targets are achieved, including planning and delegation of workload
- GLP compliant physical/chemical testing
- HPLC, GC, IC and GCMS analytical techniques
- Basic method validation using SANCO/10684/2009
- Drawing up of comprehensive study and phase plans
- Ensuring all work is reported and recorded on data sheets, in technical reports and other documents
- Formulation development for clients involving millbasing and particle size distribution, with main focus on emulsifiable concentrates
- Management, training and supervision of junior staff
- Implementation of continuous improvement activities within the workplace
- Completed RQA 'Good Laboratory Practice for study directors, principal directors, study staff and management' training
Research and Development Chemist and Production Supervisor
GEA UK Ltd
08.2014 - 12.2018
- Served as Study Director under GEA’s GLP system
- GMP representative
- Driven all European R&D projects including new product development and farm trials
- Presented my work internationally at R&D conferences (USA, Argentina, Germany)
- Competent in routine testing including titration, HPLC and GC, FT-IR and UV-Vis
- Method Validation
- Competent and practiced working under Good Laboratory Practices and Good Manufacturing Practices
- Coordinated regulatory studies concerning Biocidal products for registration
- Ensured that products manufactured by my team met quality and cost as per the production plan and ensured KPIs were achieved.
- Championed health, safety and quality.
- Provided training, instruction, guidance and advice to ensure the competence of employees, and ensure that allocated tasks were within their skills, knowledge and ability to perform safely
Pharmaceutical Scientist
Vectura Ltd
06.2010 - 08.2014
- Established and competent pharmaceutical scientist that specialises in dry powder inhaler technologies
- Experience working autonomously and as part of a team
- Competent in the use, management and maintenance of an analytical laboratory
- Follow Health and Safety regulations and comply and assist in Risk & COSHH assessments.
- Competent in the use and maintenance of HPLC, UV, Karl Fisher, FTIR
- Able to perform analysis in accordance with defined analytical methods and procedures within strict timelines
- Advanced knowledge of reviewing and reporting of data for QC release, Stability and Validation Procedures
- Able to competently amend and draft analytical methods, including operating procedures and analytical methods
- Competently write out of specification, deviation and corrective action documents
- Conduct all laboratory activities according to relevant protocols and operating procedures
- Work in a GMP environment and comply with regulatory requirements and have experience and knowledge of FDA, MHRA and ICH guidelines
- Advanced numeracy/ literacy skills including the use of a number of statistical packages
Cosmetic Laboratory Technician
LF Beauty
10.2009 - 06.2010
- Laboratory Technician within a Research and Development environment
- Responsible for the formulation of small scale pilot cosmetic products to larger scale bulk process batches
- Perform QC tests on received raw materials including FTIR and microscopic analysis
- Perform stability tests on stored small batch cosmetic samples
- Knowledge and routine use of LIMS system
Asbestos Analyst
Environmental Contamination Services Ltd
09.2008 - 06.2009
- Routine analysis of asbestos samples accumulating in an industry recognised P401 qualification
- Routine use of polarised light microscope for sample analysis
- Liase with external clients, including local councils and construction organisations regarding reporting of samples.
- Use of LIMS systems in the logging and reporting of data
Education
Bachelor of Science - Forensic Science
De Montfort
Leicester09-2008
Skills
- Quality assurance
- Regulatory compliance
- Data analysis
- Process validation
- Laboratory management
- Problem solving
- Technical writing
- Attention to detail
- Team leadership
- Method validation
Professional Qualifications
- Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management
- BOHS P401 - Identification of Asbestos in Bulk samples (PLM)
Timeline
Quality Control Manager
GlassPharms
06.2024 - Current
Senior/Lead Scientist
Vectura Fertin Pharma
01.2022 - 04.2024
Study Director
CEM Analytical Services
01.2018 - 12.2021
Research and Development Chemist and Production Supervisor
GEA UK Ltd
08.2014 - 12.2018
Pharmaceutical Scientist
Vectura Ltd
06.2010 - 08.2014
Cosmetic Laboratory Technician
LF Beauty
10.2009 - 06.2010
Asbestos Analyst
Environmental Contamination Services Ltd
09.2008 - 06.2009
Bachelor of Science - Forensic Science
De Montfort