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The job holder is required to work on their own initiative and largely independently on key responsibilities under the supervision of Senior Scientists or Pharmaceutical Development Managers.

The role is responsible for timely work on all aspects of their assigned pharmaceutical development project or process/equipment train, including client and auditor facing meetings. They are also required to liaise with, and advise, project manager and Pharmaceutical technicians to facilitate the process.

The role requires the individual to lead complex FD projects for their assigned project, produce GMP documents and lead deviation investigations and advise on CAPEX or CI improvements and support those improvement initiatives.
  • To lead Pharmaceutical drug product development, Technology Transfer and optimisation/scale-up of new projects coming from clients, external sending sites, or other PCI sites/departments.
  • To have regular liaison with Planning and Project Management to ensure project plans are accurate, and that their projects adhere to the currently agreed timelines.
  • To act as SME for their assigned project/expertise to support all internal and external technical requirements including attendance at required client and other meetings (in all forms including telephone, video link or face to face).
  • To conduct or supervise experimental work (in Operations or Laboratory) in accordance with client requirements and site standards.
  • To lead failure investigations (which may be complex) to determine root cause and support CAPA implementation (e.g. GMP Deviations or failures).
  • To ensure that production schedules are adhered to 100% of the time and where this is not possible that root causes are captured and improvements proposed and actioned (within the scope of own projects/tasks).

Some experience (equivalent to 2+ years) within a similar level role in Pharmaceutical/Chemical/Regulated processing environment, ideally OSD (Oral Solid Dosage) and Potent molecules.

Drug product development and/or Technology Transfer/scale up experience is essential

Degree educated in a suitable scientific discipline (e.g. chemistry, pharmacy, microbiology, engineering), or equivalent experience.

A higher degree in pharmaceutical processes/chemical engineering is advantageous.

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Deadline: 14-06-2024

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