We are currently seeking qualified candidates for a Director of Process Optimisation & Validation role with a leading global biopharmaceutical company. This is a permanent position that will be based out of Nottingham, United Kingdom.
The Director of Process Optimisation and Validation will lead the development of scalable manufacturing processes and support of downstream processing, with particular emphasis on scalable solid dose techniques. Additionally, the Director will coach and mentor technical team to develop their scientific and quality understanding in the field of process optimisation and validation.
- Development 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)
- Manage the streamlined transfer of processes from formulation development to GMP manufacturing
- Ensure 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
- Write and review technical documentations such as technical reports, manufacturing batch records, protocols and risk assessments
- Procurement and validation of key solid dose processing equipment
EDUCATION, SKILLS & EXPERIENCE
- Minimum of a degree in Pharmaceutical Science, Chemistry, Chemical Engineering or equivalent required.
- Experience of late stage 2- phase 3 and commercial manufacture
- Experience in QBD, risk based development.
- 10+ years of experience in drug product development with extensive knowledge and practical experience in development of ‘Fit for Phase’ solid dosage forms.
- Broad knowledge of formulation development across several dosage forms.
- Excellent organizational, interpersonal and communication skills are required.
- Enthusiastic and passionate about pharmaceutical development
- Have a high attention to detail
- Excellent numerical skills