Duties. Manager to 9 Bioprocess Engineers, bringing ADC's from development to cGMP, phase I-III and commercialisation. Client Facing. Responsible for: • Day to day management of the technical transfer team • Organising and running training sessions for the team • Recruitment and resource management to meet the siting of new process introduction • Client communication: Progress updates, trouble shooting • Writing and reviewing URS / Process Descriptions /SOP’s / Reports / Deviations/ Change Controls • Standardisation of equipment, consumables and documentation • Sourcing alternative components considering process suitability, MOC, E&L and vendor status • Training and participating in programing process recipes for automated process skids. • Proposal request for new business • Scale up design • CPV data gathering and data analysis

Piramal Pharma Solutions | Nov 2019 - May 2021

Continuous Improvement Manager

As a Continuous Improvement Manager I am responsible for managing the operational excellence projects across site. The projects vary in size and complexity but ultimately fall into the typical CI categories i.e. Kaizen, Lean, TOC and Six Sigma. I manage between 10 and 20 CI projects at a time with my time split between managing the projects and working on the projects personally. Responsible for: • Developing a Continuous Improvement Culture. • Managing the CI projects across site. • CI communications across site. • Training and development in CI • Managing the CI projects across site. • Route cause analysis expertise. • Manufacturing advisor on the site expansion project panel.

Piramal Pharma Solutions | Nov 2018 - Nov 2019

Manufacturing Process Improvement Manager

managing projects to standardise manufacturing equipment, consumables and documentation and drive efficiencies. The projects in this role included: 1. Standardising the documentation used to sanitise process equipment. 2. Standardising the documentation used to sanitise vessels and TFF systems for use in the manufacture of biopharmaceutical bulk drug substances. 3. Writing, re-writing and updating existing SOP’s in alignment with current practice; documentation tidy up. Day to day tasks and responsibilities were: • Project management of assigned projects. • Writing documentation (SOP’s, Bath Manufacturing records, Reviews, Change Controls etc.). • Chairing meetings. • Change management. • Managing change controls. • Working to project timelines to ensure the batch documentation is in place in time for manufacture. • Writing training packages. • Practical training staff on new processes. • Provide technical support to manufacturing.

Symbiosis Pharmaceutical Services Limited | Oct 2017 - Nov 2018

Manufacturing Team Leader

As Manufacturing Team Leader I am responsible for the routine operation of all manufacturing activities of sterile pharmaceutical on site. I establish the day-to-day priorities in pursuance of established production programs, and motivate my team in the successful execution of the tasks required to achieve the targets whilst maintaining high standards of safety and cGMP. In addition I also work myself in the cleanrooms to help and to supervise the manufacture of sterile pharmaceuticals. Responsible for: • Man management of 8 technicians and 2 senior technicians. • Micro scheduling with Microsoft project. • Problem solving. Finding ad hoc solutions to manufacturing problems at line in line with cGMP compliance, quality and technical guidelines. • Writing non-conformances using root cause analysis techniques such as DMAIC, fishbone and 5 whys. • Complex formulations • Client interaction/communications. • Sterile fill and finish. • Prioritisation of work through spreadsheets. • Updating existing documentation and writing new documentation (continuous improvement). • Holidays/absenteeism/disciplinary process/one to one sessions with staff. • Attending and chairing meetings. • Ensuring timely and accurate completion of batch records. • Training staff. • Team building/ Motivating staff.

Piramal Pharma Solutions | Jan 2014 - Oct 2017

Shift Team Leader

Shift Team Leader (STL) Jan 2014 - Present Duties. In my current role as Shift Team Leader I am responsible for the routine operation of all manufacturing activities of Antibody Drug Conjugates on site. I establish the day-to-day priorities in pursuance of established production programmes, and motivate my team in the successful execution of the tasks required to achieve the targets whilst maintaining high standards of safety and cGMP. Responsible for: • Man management of 8 technicians and 2 senior technicians. • Writing deviation/investigations, using root cause analysis techniques such as DMAIC, fishbone and 5 whys. • Updating existing documentation and writing new documentation (continuous improvement). • Scheduling. • Holidays/absenteeism/disciplinary process/one to one sessions with staff. • Conducting handovers. • Attending and chairing meetings. • Ensuring timely and accurate completion of batch records. • Training staff. • Team building/ Motivating staff.

Piramal Pharma Solutions | Jul 2012 - Jan 2014

Senior Manufacturing Technician

The Senior Manufacturing Technician role provides on the floor supervision to a team of manufacturing technicians during the production of Bulk Formulated Antibody Drug Conjugates. Responsible for: • Day to day on the floor man management of a team of 5 manufacturing technicians. • Implementation and maintenance of manufacturing schedules. • Overtime control. • Performing process deviation investigations using root cause analysis techniques (Ishikawa fishbone, DMAIC, 5 Whys) in a timely manner to prevent reoccurrence. • Managing document updates to support Quality Management System improvements by continuous improvement. • Working with a team in compliance with Standard Operating Procedures. • Ensuring safety requirements are adhered to (COSHH, ESH). • Providing leadership within the shift to establish the most efficient work practices. • 5S implementation and review. • Communicating with customers.

Piramal Pharma Solutions | Jul 2010 - Jul 2012

Manufacturing Technician

Manufacturing Technician (MT) Jul 2010 – Jul 2012 As a manufacturing technician I carried out the synthesis of Highly Potent and Cytotoxic Bulk Formulated Antibody Drug Conjugates and small molecule Active Pharmaceutical Ingredients under cGMP conditions. Responsible for: • cGMP requirements (from early phase clinical trial to commercial manufactures). • HPLC technology – AKTA and K-Prime. • TFF systems – Sartorious, Millipore, Pall. • Equipment Qualification (URS, DQ, IQ, OQ). • Analytical techniques (HPLC, UV, Endotoxin, Conductivity, pH). • Cleanroom technologies and Aseptic Handling. • Handling highly potent materials (Isolators and Barrier Technologies). • Working within Biosafety Cabinets. • Fork Lift Truck driving (licence held). • Environment, Safety and Health regulations.

Express Microbiology | May 2010 - Jul 2010

Asisstant Microbiologist

Streaked and transferred samples onto appropriate media, organised samples in designated incubators. Maintained sterility through aseptic technique. Constantly working to control contamination.

Alcontrol Laboratories | Mar 2010 - May 2010

Laboratory Technician

Worked in a fast pace micro lab. Prepared samples for various assays. Enumerations, plate pouring, preparing growth media and stored samples in their appropriate incubators. General lab tidying was also a component.

Aptuit | Mar 2008 - Aug 2008

Prodution Associate

Worked under GMP, GLP. Wrote SOP’s, operated autoclave and oven, sterilised lab equipment. Clean room preparation (Completed 2 successful gowning procedures for sterile manufacture), prepared and transferred materials for entry into clean room through use of transfer hatches.

My Education

Take a look at my formal education

Data Scientist, Computer ProgrammingDataCamp | 2021

Bachelor’s Degree, MathematicsThe Open University | 2012

Honours Degree, Biochemistry and ImmunologyUniversity of Strathclyde | 2007

High School Calderhead High School | 2000

About Me

I am scientist working in the manufacture of Biopharmeceuticals.

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