As the senior engineer leading a team of engineers, you will be integral to the development of the manufacturing processes for Midatech Pharma’s product pipeline.
This will include taking a major role in the technical decision making with regard to the manufacture of selected drug product candidates and acting as the primary resource for addressing the engineering and manufacturing challenges which arise as candidates are taken from R&D, through the clinical phases and into commercial manufacture.
You will provide a problem-solving mindset and drive innovation, supported by utilising established engineering techniques and processes and a Quality Risk Management approach. Accordingly, you will be familiar with interpretating and utilising the guidelines detailed in ICH Q8 & 9 to support early to late clinical stage drug product development and manufacture.
You will also be responsible for developing cutting edge manufacturing processes for new drug product candidates, applying the experience gained from previous manufacturing processes and delivering a continual improvement in the application of the Q-Sphera platform in particular.
- Inhouse Technical Lead on design and fabrication of bespoke manufacturing equipment
- Develop and manage technology transfer (process) to contract manufacturers to establish GMP-compliant capability
- Planning the engineering department’s work schedule and making accurate assessment of resource and budget requirements
- Managing the engineering department overall budget, to include; staff costs, R&D costs, equipment maintenance and engineer training costs
- Growth and development of engineering department to meet resource and technical requirements
- Assigning work, providing direction and evaluating the technical output of members of the engineering department ahead of consumption by external stakeholders
- Overseeing the development of the engineering department staff skillset through regular performance reviews according to Midatech’s internal appraisal system
- Developing and implementing policies, standards and procedures for the engineering department and wider pharmaceutical and technology development function
- Performing administrative functions such as reviewing and writing reports, approving expenditures, approving leave, managing sickness absences and making decisions about the purchase of materials or services
- Complying with responsibilities as defined in the Group’s Health, Safety & Environment Policy and ensure compliance with the same throughout the team.
- Liaising with R&D and analytical teams
- Liaising with external equipment and service suppliers
- Project lead for process development and technical transfer projects
- Provision of status reports, analyses and engineer project plans to senior management
- Travel to other sites (UK and Europe)
|Minimum education level||Bachelors Degree in Chemical Engineering, Mechanical Engineering or other related subject.|
|Industrial experience||The candidate is required to have a background in pharmaceutical manufacturing process development, with experience of sterile parenteral products and complex processes highly desirable. Experience of technology transfer and overseeing outsourced manufacturing activities is required.|
|Supervision received by the role||The successful candidate will work as part of a multidisciplinary team, and report directly to VP Pharmaceutical and Technology Development. Regular performance reviews will be held but after initial orientation it is expected that the candidate will perform duties in a very self-sufficient fashion.|
|Supervisory responsibility||The position will supervise the Engineering Team, with responsibility for developing and growing the team to support project and company growth.|
VP Pharmaceutical and Technology Development
Cardiff, UK with occasional travel as required
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