Reporting to the Head of R&D, the VP Pharmaceutical and Technology Development will be responsible for the technical leadership of formulation development, process development, clinical trial manufacturing and technical operations teams at Midatech Pharma’s R&D site in Cardiff, ensuring corporate commercial and operational goals are delivered. As a key member of the Senior Management Team, this role has substantial influence over R&D strategy and development activities.
With responsibility for CMC activities across all of Midatech Pharma’s platform technologies, this role will provide technical leadership to the Pharmaceutical Development, Analytical Technology and Process Engineering teams. Acting as the primary technical interface with customers, the role will support the assessment of new opportunities and RFP’s, developing proposals and overseeing internal and partnered feasibility, development and manufacturing projects.
With an excellent knowledge of best practise pharmaceutical development, the role will drive and guide development of novel manufacturing processes from lab to early clinical phase through to market, will facilitate a solution-focussed, scientifically robust culture that meets quality and regulatory compliance requirements. With a major focus on drug delivery, the role requires knowledge of parenteral drug product development and manufacture. Familiarity with particulate-based (micro- and nano-particle) technologies is advantageous, particularly knowledge of polymer-based controlled release technologies. The role will grow the operational, process and analytical capabilities to complement the current and growing needs of the company. The post-holder will actively support the Quality and Compliance function, providing technical input on a range of drug development activities.
The role will provide a problem-solving mindset to help drive innovation, supported by established engineering, analytical and pharmaceutical development techniques. Accordingly, the post-holder will be familiar with interpretating and utilising ICH, GMP and GCP guidelines. Working knowledge of Quality by Design and quality risk management are required.
- Line management of CMC formulation, analytical and engineering teams in Cardiff
- Provision and support of experienced CMC technical representatives as functional leads on R&D project teams
- Facility management, including health and safety standards, for the laboratories in Cardiff
- Responsibility for the management of CMC activities to ensure delivery of pharmaceutical development and GMP clinical trial manufacturing aspects
- Providing technical leadership on the development of new drug products and development of proprietary drug delivery technologies
- Selection and management of CDMOs for development and manufacturing activities (GMP and non-GMP)
- Oversight of process scale-up and technology transfer activities
- Generation and capture of new IP, to include working with technical and legal experts to ensure a broad and robust IP position is maintained
- Ensuring all activities are conducted in line with the necessary health & safety, quality and regulatory compliance requirements, in accordance with company and external guidelines
- Ensuring adequate recruitment, training and employee development to maintain a highly motivated, skilled and efficient group to meet the needs of the business
- Development and management of project budgets
- Working with the Project Management to ensure the delivery of projects on time and budget
- Liaising closely with the Quality Function to drive capabilities around the management of Quality aspects
- Provide a smooth and safe operation of laboratories and identify opportunities for improvements in working practices and procedures
- Foster and maintain a high degree of innovation and forward-thinking within the team
- Anticipate technical blockers and act to address
- Provide regular progress updates to senior management team and attend board-level meetings as required
Other General Responsibilities
- 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.
- Business travel as required (UK, Europe and US)
|Minimum education level||PhD|
Senior level CMC experience in pharmaceutical development with extensive knowledge of secondary manufacturing of small molecule pharmaceuticals (injectables preferred). Knowledge and experience of API manufacture and large molecule development and manufacturing would be advantageous.
Excellent knowledge, through experience, of the relevant CMC and supply chain aspects of developing, manufacturing and commercialising pharmaceutical products along with a good working knowledge of the pharmaceutical industry, relevant regulations and requirements.
Experience of FDA/EMA interactions as needed to support advancement of products through clinical development stages.
Experience creating and defending CMC development strategy, plans and data packages. Project leadership experience, specifically leadership of multi-disciplinary teams in a relevant pharmaceutical product development environment. Experience working at a senior level with both internal and external groups. Experience of sterile parenteral products and complex formulations.
|Supervision received by the role||The successful candidate will work as part of a multidisciplinary senior team, and report to the Chief Scientific Officer. Periodic 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 Pharmaceutical Development, Analytical and Engineering Teams, with responsibility for developing and growing these teams to support project and company growth.|
Willingness to work from the company’s office in Cardiff at least 4 days a week
Legally authorised to work in the UK
VP Pharmaceutical and Technology Development
Chief Scientific Officer
Cardiff, UK with travel as required
How to Apply
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