Manufacturing Manager

An exciting and challenging opportunity has arisen for a Manufacturing Manager within a leading Contract Development and GMP Manufacturing Organisation in the ever-evolving field of Biologics and Regenerative Medicine.

As a commercially structured operation, the company displays considerable ambition in both leading the market and in building an effective physical model to meet the demand that is envisaged. This Edinburgh-based company operates at the leading edge of therapeutic discovery providing services for companies involved in European and US clinical trials.

This is a unique opportunity for an experienced Manufacturing Manager to manage the contract manufacturing operation, be a key member of the senior management team and report directly to the CEO.

This is a role for an effective leader to lead, motivate and develop the team of GMP Production Scientists in the field of Regenerative Medicine. My client aim is to work to the highest standards of quality and regulatory compliance and are looking for an individual who shares in these values. The individual must have a sound scientific knowledge of cell manufacturing and the ability to expand the Manufacturing operation and take the department to the next level on the new, state of the art facility.

The company is embarking upon an exciting journey of growth and is looking to fully support and develop its employees to ensure future career progression.

Specific Responsibilities:

  • To provide ongoing practical training and advice to staff particularly in cell biology and sterile manufacturing.
  • To create, review and approve quality documents such as SOPs, BRs, incident reports, change controls and risk assessments within agreed time scales.
  • To ensure that the Manufacturing clean rooms and equipment are maintained, serviced and validated to a GMP standard.
  • To ensure the standards of housekeeping within the facility are maintained to a high standard.
  • To create, review and approve technology transfer documentation and review processes for GMP manufacture both scientifically and for GMP compliance.
  • To work closely with customers to successfully transfer customer manufacturing processes
  • Develop and motivate the team to ensure they deliver on goals and achieve appropriate standards of work.
  • To ensure that all Manufacturing staff are fully trained for their responsibilities and review and sign off (where appropriate) their personal training records.

Desired Skills and Experience

The successful candidate will have:

  • A PhD or honours degree in a relevant life science or equivalent qualification
  • Experience of sterile manufacturing particularly within a GMP clean rooms operating at a Grade B level with Grade A cabinets
  • A sound working knowledge of GMP and the ability to lead others to maintain and uphold GMP standards across all manufacturing activities
  • A proven track record of successfully managing a team in a GMP environment.
  • Experience with technology transfer and process development would also be desirable.
  • Experience with Quality Management Software
  • Experience in the successful management in GMP Production

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+44(0)131 523 1370
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