A skilled and self-motivated process leader, with experience in manufacturing to cGMP and containment category 3 standards. Experienced in aseptic processing and working in class III microbiological safety cabinets, in both fermentation and downstream processing aspects of manufacture.

Self-aware and able to work confidently under own initiative and as a part of a team. First-class skills in writing of documents in line with industry standards, cGMP and regulatory standards. Dedicated to maintaining high quality standards through continual attention to detail. Able to confidently prioritise work loads whilst working under pressure and to deadlines. Computer literate.

5yrs experience gained whilst working in the manufacture of a biological vaccine in a newly built category 3 containment manufacturing facility. Directly involved in all aspects of the qualification of this facility leading to successful manufacture. Successfully manufactured thirteen batches of product that have met the required specification. Currently manufacturing the consistency batches for BLA submission.

Jun 2002 - dateIPSEN BIOPHARM LIMITED

Nov 2003 - dateProcess Leader - Downstream Processing

• Leading the Downstream Processing part of the production process by the planning and organising of all aspects of the production process.
• Excellent communication skills gained through liaising with both internal customers and suppliers and external representatives.
• Responsible for the generation of all training packages related to the manufacturing area and the formal training of all team members.
• Planning and performing routine GMP and Safety audits within the Production department and therefore maintaining an inspection ready status at all times. Responsible for the delegation and management of any corrective actions arising and ensuring that these are closed out in a timely manner.
• Responsible for raising any required process unplanned events and change controls using TrackWise®.
• Specifically chosen to be responsible for major changes in the format and content of batch manufacturing records due to a demonstrated high standard of attention to detail.
• Give guidance to junior members of the team on the generation of documents such as Risk assessments and basic equipment standard operating procedures.
• Participated in fault tree analysis for the production process.
• Provided technical input for the Performance Qualification of the microbiological safety cabinets, planned and organised the execution of this work.
• Responsible for the generation of the following documentation for the production process and the associated equipment:
  • Batch Manufacturing records / Standard Operating Procedures
  • Risk and Manual Handling Assessments ensuring they meet the current ACDP (Advisory Committee on Dangerous Pathogens) guidelines
  • Technical Protocols and Reports
• Responsible for reviewing and approving the following documentation for various pieces of production equipment:
  • Installation/Operation/Performance Qualification Protocols and Reports
  • Cleaning Validation Protocols and Reports
  • Technical Protocols and Reports
• Directly involved in the planning, generating and executing of a series of experimental studies to increase our product understanding and improve the production process.
• Directly involved and worked with our technical department in studies to improve the column packing process. Responsible for the organising of equipment and resources for this.
• Currently the departmental health and safety representative.
• Successfully completed both a Health and Safety (HSE) site inspection and a MHRA audit of the production facility. Directly involved in the preparing and maintaining the production facility for these. Also involved in preparing and maintaining the production facility for mock audits by ex FDA inspectors.

Dec 2002 - Nov 2003Senior Process Technician

· Writing of Standard Operating Procedures for various pieces of production equipment ensuring that these encompass cGMP, safety and industry standards.

· Writing of Risk assessments and manual handling assessments for individual process steps of the production process.

· Actively involved in the execution of qualification protocols with validation department on several pieces of equipment.

· Set up a safe and secure storage area for location of breathing apparatus sets. Planned, designed and purchased storage cupboards and accessories required for safe storage of compressed air cylinders.

· Ensured all safety equipment required in the production process was always available and tested.

· Through communication with external suppliers gathered certification for all product contact items. Liaised with supply chain department to set up all consumable items as store stock items.

· Generated equipment and reagent requests for the fermentation parts of the process. Ensured that these were submitted to the media preparation department with the required notice.

· Responsible for generating all sample and product labels and QC sample request forms required during the production process.

Jun 2002 - Dec 2002Process Technician

· Writing of Risk assessments and Manual Handling assessments for equipment.

· Checking and maintaining stock levels of consumables required for use in the production process.

· Routine cleaning of the production clean room suite in accordance with the relevant procedures.

· Maintaining all equipment log books. Ensuring completion to cGMP standards.

· Cleaning and setting up of microbiological safety cabinets for use.

Numerous courses undertaken, including but not limited to:

Principles of Fermentation (MBI, University College London)

Chromatography (MBI, University College London)

Sterilisation, Principles in Practice

Trainer training

Pharmaceutical cGMP

Representative of Employee Safety (RoES)

BSc. (Hons) 2.2 in Biochemistry at Lancaster University (2002).

4 A Levels: Chemistry [B], Biology [C], Mathematics [C],

General Studies [C]

9 GCSEs