Production Team Leader

We are currently looking to hire a Deputy Head of Drug Product Manufacturing on a permanent basis. The role will be co-ordinating and managing scientists and technicians involved in the dispensing, manufacture and supply of oral and intravenous clinical products in accordance with GMP requirements and company procedures.

The role will be focussed on sterile manufacturing processes and technology , aseptic processing and regulatory requirements. The role will require a ‘hands on’ approach to ensure the drug products are manufactured on time to the correct quality and specification.

Main tasks and responsibilities

• Apply scientific expertise and experience to the manufacture and supply of oral and intravenous products for human use.
• Prepare, review and where appropriate approve, documentation associated with the manufacture and supply of Investigational Medicinal Products.
• Guide other team members of the GMP manufacturing team to ensure that products of the correct quality are manufactured and documented in compliance with relevant regulatory requirements, internal policies/procedures and client needs.
• Co-ordinate the cleaning, maintenance, validation, GMP material inventory stock control and upkeep of the GMP Drug Product manufacturing facility, utilities and equipment.
• Effectively lead the site media fill program, including operation training and qualification, site gowning practices, environmental monitoring program, sterilisation practices and aseptic technique.
• Responsible for contributing to the cleanroom operation and contamination (cGMP) in the performance of the day to day activities.
• Develop and maintain training programmes.
• Work with Formulation Development scientists to translate developed formulations/process’ to final clinical products.
• Collaborate and liaise with the other site support functions; Microbiology, Quality Control, Quality Assurance, Soft Services and Facility Management.
• Manage and support manufacturing investigations, including root cause analysis, CAPA generation and impact assessment.
• Advise clients and colleagues on GMP standards to be applied during drug product manufacture.
• Support the conduct of internal, client and regulatory agency audits of the GMP Drug Product manufacturing capabilities.
• Deputise for the Head of Production when appropriate to discharge the responsibilities of the ‘Head of Production’ on the site MIA (IMP) Licence and according to internal procedures.
• Work with due regards to health and safety of self and others.
• Work flexibly across the site to meet business needs.

Qualifications and experience required

• BSc (hons) or equivalent in a relevant scientific subject.
• Extensive knowledge and experience of pharmaceutical manufacturing including sterile manufacturing processes and technology and aseptic processing.
• Good awareness of the current GMP regulatory environment.
• Knowledge of the drug development process.
• Knowledge of SOPs, cGMPs and how to work and manage within a regulatory environment.
• Experience in guiding professional or technical staff.
• Demonstrate the ability to coach and lead change.
• Good written and oral communication skills.
• Have a flexible approach to new work challenges.

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