Production Unit Manager
Salary: Circa 35k.
We are looking for someone that is highly motivated, well organised and have been educated to degree level or equivalent or have substantial management experience within a GMP biopharmaceutical manufacturing facility. The candidate will be responsible for managing three teams which comprise of Seed Production, FPP Compliance and the FPP Support.
Applicants are strongly advised to use the criteria in the job description/person specification as sub-headings in their application to make it clear how they meet each of the selection criteria.
The successful candidate will be responsible for overseeing three teams which comprise of Seed Production, FPP Compliance and the FPP Support. The Seed Production team ensures the timely supply of seed for inoculation into the production bioreactor, meeting agreed production schedules and quality requirements. Generation and maintenance of both master and working cell banks for manufacture as required. The FPP compliance team ensures that BMRs are available for production use; raw materials are ordered and available for production use. Post manufacture, batch records are collated and initial review performed prior to sending to Quality. Downloading and storage of raw data files, and general ordering.
MAIN DUTIES AND RESPONSIBILITIES:
Responsible for the timely supply of seeds for the inoculation into production bioreactor for Erwinase to meet agreed production schedules.
Responsible for the compliant maintenance of master and working cell banks and have a thorough appreciation of the regulatory requirements involved.
Maintain a viable stock of working cell bank material by timely manufacture of new working cell banks from the master cell bank.
Ensure the unit is ready at all times for audit by any regulatory body.
Maintain requirements involved in controlling containment within FERA regulations.
Manage the FPP compliance team to ensure compliance is maintained during manufacture and that policies and procedures are applied when necessary.
Manage the FPP support team to ensure routine cleaning, monitoring and clothing supplies are completed in compliance with the agreed production schedules.
Liaise with engineering and validation to ensure the unit stays within compliance and is ready for operations when required.
Experience of working within a GMP quality system and responsible for Non Conformances, CAPA, Risk Assessments and Change Controls for the area. Ensuring SOPs and BMRs are available for use.
Ensuring staff are trained for their required area of work.
Degree in a biological sciences discipline or significant related experience.
Previous management experience of working in a GMP biopharmaceutical manufacturing facility.
Experience of aseptic techniques.
Understanding the regulatory requirements involved in controlling containment within DEFRA/APHA regulations.
Comprehensive understanding of critical utilities, calibration, validation and maintenance activities associated with GMP manufacturing
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- Production Management