JOB DESCRIPTION

Title:    Process Technician    

Reporting to: Manufacturing Team Lead    

1. PRINCIPAL DUTIES

Strategic Objectives:

• Manufacturing of Synthetic Vaccines:
  • Responsible for the day-to-day manufacturing operations ensuring that Phase I and Phase II clinical materials are manufactured on time in accordance with the agreed Manufacturing Plan.

• Technical Life Cycle Management:
  • Continuously supporting the manufacture of products through the product lifecycle management programmes, aimed at improving and optimising manufacturing processes.

• • Providing hands-on manufacturing support in the technology transfer of products being transferred from the main site to other future sites, partners and independent CMOs.

Quality Objectives:

• GMP Manufacturing
  • Responsible for Supporting manufacturing deviation investigations and root cause analysis meetings.

• • Responsible for carrying out daily checks in the Manufacturing and supporting areas.
    
  • Responsible for ensuring all procedures relating to the daily operations within the GMP manufacturing suite meet the current GMP requirements and associated guidelines.

• • Responsible for generating training plans, work-based training packages and training out all operators within the GMP manufacturing suite.

• • Responsible for ensuring that all equipment within the GMP Manufacturing Suite is within calibration, servicing, and qualification dates at all times.

Additional Objectives:

• Documentation:
  • Writing all required Manufacturing Documentation such as:

• • • Writing User Requirement Specifications (URS’s) for new equipment required for the manufacturing area.

• • • Writing Material Specifications required for chemical raw materials, starting materials and consumables required for the manufacturing process.

• • • Creating logbooks for facility activities & new equipment.

• • • Writing & updating SOPs for equipment used in the manufacturing area.

• • • Writing & updating Batch Manufacturing Records for all stages of the process.

• • • Writing safety related documentation such as COSHH assessments and process safety Risk Assessments.

• • • Write Changes Controls and CAPA Actions.

• Hands-on Manufacturing
  • Hands-on manufacturing of Base GNP and PepGNP processes involving use of Reactor vessels, Tangential Flow Filtration (TFF) System, final filtration of bulk solutions to cGMP standards. .

• • Responsible for ensuring that all consumable stock levels are maintained within the GMP manufacturing facility and ensuring all raw materials are within their expiry dates at all times.

• • Responsible for the daily operation of the GMP manufacturing site

• • Responsible for supporting the execution of Maintenance & Calibration Work Orders associated with the GMP manufacturing Area.

• • Responsible for maintain the cleanliness of the Grade C manufacturing rooms via good aseptic practices and scheduled cleaning activities

• Warehouse
  • Assist in the purchasing, receipt and issue of raw materials and consumables for use in the GMP manufacturing facility.

• • Responsible for the correct labelling, segregation and control of all raw materials and consumable required for the GMP manufacturing facility

• • Assist in co-ordinating the sampling of Raw Material Chemicals

• • Assisting the Warehouse Manager and QC in the packaging & shipment of final Drug Substance, QC samples, Environmental Monitoring Samples and intermediates

1. EXPERIENCE & QUALIFICATIONS

• Experience
  • At least 1 to 2 years’ experience in the pharmaceutical industry working to cGMP standards.

• Education:
  • Scientific / pharmaceutical degree or sufficient in role experience.

• Technical Skills:
  • Pharmaceutical production. Direct GMP experience
  • Experience in the operation of reactor vessels is desirable
  • Must have experience in downstream processing. Experience with Tangential Flow Filtration (TFF) System is desirable.

1. PROFILE OF THE CANDIDATE

This is a very small company so the ideal candidate has a willingness to try new skills and has a flexible nature.

   Computer Literacy:

• MS word
• MS Excel

Interpersonal Skills:

• Relevant experience with varied interaction in a task orientated environment
• Good communicator
• Prizes honesty and integrity

Written and oral communication skills:

• Written skills: accuracy
• Good attention to detail
• Oral communication: friendly, courteous, helpful and respectful

Dedication to task and delivery

• Service orientated
• Completes tasks with integrity and thoroughness
• Maintains high levels of accuracy
• Completes tasks efficiently
• Strives to achieve high standards

Organising/coordinating skills:

• Ability to plan and schedule tasks to meet deadlines
• Ability to deal with confidential matters
• Ability to multi-task without compromising on quality when completing tasks

Leadership skills:

• • Provide guidance and develop less experienced team members:

1. Train manufacturing team members in the use of key process equipment
2. Train the manufacturing team in the process being transferred ensuring it meets the required and current GMP requirements and associated guidelines.