- Accountable for technical leadership of the formulation development of NME currently in late stage clinical development.
- Work as part of the cross functional CMC team under the leadership of the Director, CMC.
- Scope development programmes to be executed by CMOs ensuring scientific rigour.
- Review and approve GMP documents such as validation protocols, master batch records etc.
- Onsite support for the Head of Quality Management with audits of CMOs.
- Contribute to the creation of a Quality Management System (GMP) and subsequently ensuring compliance with all SOP’s and regulatory requirements.
- Work with CMOs and regulatory writers to author sections of regulatory submissions; IMPD, IND in the short term leading to NDA, MAA.
- Work with CMOs on post approval inspection readiness activities including preparation of playbooks.
- As part of F2Gs Breakthrough Therapy designation prepare for and contribute to meetings with the FDA to establish the CMC development plan for initial launch and post launch commitments.
- BSc Hons or PhD in chemistry, chemical engineering, pharmacy or pharmaceutical sciences.
- 10+ year experience in formulation development roles.
- Phase 3 and/or new product introduction (launch)
- NDA/MAA module authorship desirable
- QbD experience desirable
- Proven experience of delivery through CMOs.
- Experience of working with poorly soluble small molecules and associated enabling technologies.
- Experience on solid oral and parenteral formulation development and manufacturing essential.
- Experience of authoring IMPD and/or IND modules.
- Thorough understanding of GMP and relevant regulatory guidelines.
- Professional membership (e.g. Academy of Pharmaceutical Sciences) desirable.
- Paediatric formulation development experience desirable.
- Experience of commercial primary and secondary packaging configuration desirable.
- Strong quality focus, experience in a GMP environment.
- Understanding of regulatory expectations and profound scientific knowledge in pharmaceutical development.
- Work collaboratively with energy and enthusiasm as part of a team and broader network.
- Self-motivated, able to identify opportunities for improvement, build a case for change and then lead the change implementation.
- Conscientious with a can-do attitude with excellent attention to detail.
- Comfortable operating in a business that is hands on, flexible and proactive and demonstrate Intellectual rigour, insightfulness and sound judgement.
- Excellent verbal, written and presentation skills.
- Able to think creatively, provide innovative solutions.
To apply please send your CV and covering letter
stating current salary to:
Suzi Powell, Office Manager, F2G Ltd, Lankro Way, Eccles, Manchester M30 0LX