Director of Process Optimisation and Validation
Based in Nottingham our client specialises in the formulation development, analytical services and clinical manufacturing for pharmaceutical clients globally. Working within the Formulation Process Optimization and Manufacturing functions this specific role will focus on the following activities:
- Manage the streamlined transfer of processes from formulation development to GMP manufacturing
- Develop strategies and manage the late stage process validation activity for commercial manufacturing of solid dose drug products
- Write and review technical documentations such as validation protocols, technical reports, manufacturing batch records, and risk assessments
- Contribute to the writing of CMC sections (2 and 3) of regulatory documents for IMPDs, INDs, NDAs and MAAs and / or responding to agency questions
- Lead the procurement and validation of key solid dose processing equipment
- Support the development and optimisation of scalable manufacturing processes and support of downstream processing, with particular emphasis on scalable solid dose techniques (Solid Dispersions (Spray-drying, Hot-Melt Extrusion/Spheronisation), Granulation, Milling, tablet-coating)
- Support the manufacture of clinical products in accordance with cGMP, agreed specifications and in-house Quality standards.
- To coach and lead junior members of the team
The ideal candidate will be/have:
- Minimum of a degree in Pharmaceutical Science, Chemistry, Chemical Engineering or equivalent required.
- Minimum of 5+ years of experience in drug product development with extensive knowledge and proven practical experience in the late stage optimisation and transfer into commercial manufacture of solid dosage forms.
- Experience of late clinical phase 2- phase 3 and small scale commercial manufacture
- Experience in leading implementation of risk-based development (Quality by Design) across multiple programs and technology platforms
- Broad knowledge of formulation and process optimisation across several dosage forms and technologies.
- Proven success and planning and executing process verification in accordance with FDA stage 1 – stage 3 criteria and EMEA guidance
- Proven expertise in implementing process capability analysis, statistical process control and product and process monitoring strategies to ensure appropriate product quality.
- Ideally exposure to pre-approval inspections and or routine cGMP inspection from major regulatory agencies
- Experience of working on small volume commercial processes and manufacturing strategies for rare diseases / breakthrough therapies
- Excellent organizational, interpersonal and communication skills are required
- Enthusiastic and passionate about pharmaceutical development
- Have a high attention to detail
- Excellent numerical skills
- Competitive salary
- Discretionary annual bonus
- Contributory Pension scheme
- 25 days holiday - plus bank holidays
- Death in service
- Healthcare provision
- Free parking
- Childcare vouchers
- Health Shield
- Learning & Development opportunities
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