An established pharmaceutical company has an exciting opportunity for a Formulation Development Manager to join its team. This is a new role with the focus being on leading formulation and prototype development activities. You will support early-stage solid oral dose formulation development and provide guidance and practical support to customers on formulation, regulatory and technical challenges. To be considered you must have demonstrated experience in solid dose formulation with working knowledge of early-stage regulatory approval.
The Formulation Development Manager leads fformulation and prototype development activity for customers, they support early-stage solid oral dose formulation development and provide guidance and practical support to customers on formulation, regulatory and technical challenges. The role will involve significant customer interface including travel to customer sites, discussing project requirements, supporting promotional activity, prospecting for new customers and identifying new opportunities. The role also provides technical leadership to colleagues on formulation best practices in the Formulation Development Centre (FDC) and engaging prospects in early development discussions
- Supports identifying and engaging suitable companies with assets at an early stage of formulation development where Company and help and support their excipient selection process. There will be travel to visit customers and promote Company formulation capability
- Formulation development.
- Leads introducing Company formulation development capability to new early stage customers
- Initial project review, screening activity and developing prototypes and data to support the API progression to clinical trials
- Management of new projects and formulation activity.
- Support Formulation and Prototype development promotional material development
- Preparation of new presentations
- Promotional material and training
- Presentation of project summary / data package to new customers
- Support development of early formulation development literature for internal and external use
- Formulation Capability / Expertise Promotion & Development
- Support events that promote Company's early-stage formulation development capability
- Creates and engages a network of small ETRX, Biotech, consultants & CROs
- Formulation / Industry Trends
- Track new delivery platforms / excipients and formulation habits in industry and looks to develop applications data that supports Company product selection
- Formulation leadership
- FPDC lab capability development and training and support of ATM projects
- BSc, ideally with a PhD in a Pharmaceutical Sciences related discipline.
- Formulation team leader with significant years prior solid oral dosage experience in pre-formulation, biopharmaceutics and material science with hands-on lab experience formulating novel drug substances at a small scale.
- Extensive knowledge of development pharmaceutics and understanding of how drug substance physical / chemical attributes affect formulation development options
- Demonstrable understanding of processes for oral solid dosage forms with proven ability to lead discussions on technology selection
- Experience with standard pharmaceutical techniques such as direct compression, granulation (HSWG, FBG), roller compaction, drug layering, spray drying, hot melt extrusion, encapsulation and coating of SODs.
- Prior knowledge of the early-stage regulatory approval process including experience of authoring CMC modules to support regulatory submissions, development of dossier components to support regulatory submissions, development of dossier components to support IMPDs and Investigational new drug applications (INDs/ CTAs).
- Experience working with or at a CRO to support pre-clinical formulation development and progression to clinical trials
- Excellent written and oral communication skills. Demonstrable ability to prepare and present highly technical information
- Excellent project planning and/or time and resource management skills/ prioritisation processes
- Proven leadership and self-development skills. Demonstrated ability to function within a matrix organizational structure
- Familiar with CRM systems and proficient in use of MS Teams, Excel, Word and PowerPoint.
You must have the right to work in the UK. Learn more
- Agency: Cranleigh Scientific
- Reference: 7077
- Updated: 28th September 2021
- Expires: 26th October 2021