Head of Formulation Development Vacancy

Key Responsibilites:

  1. Accountable for technical leadership of the formulation development of NME currently in late stage clinical development.
  2. Work as part of the cross functional CMC team under the leadership of the Director, CMC.
  3. Scope development programmes to be executed by CMOs ensuring scientific rigour.
  4. Review and approve GMP documents such as validation protocols, master batch records etc.
  5. Onsite support for the Head of Quality Management with audits of CMOs.
  6. Contribute to the creation of a Quality Management System (GMP) and subsequently ensuring compliance with all SOP’s and regulatory requirements.
  7. Work with CMOs and regulatory writers to author sections of regulatory submissions; IMPD, IND in the short term leading to NDA, MAA.
  8. Work with CMOs on post approval inspection readiness activities including preparation of playbooks.
  9. 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.

Skills/Experience Required:

  1. BSc Hons or PhD in chemistry, chemical engineering, pharmacy or pharmaceutical sciences.
  2. 10+ year experience in formulation development roles.
  3. Phase 3 and/or new product introduction (launch) experience
    1. NDA/MAA module authorship desirable
    2. QbD experience desirable
  4. Proven experience of delivery through CMOs.
  5. Experience of working with poorly soluble small molecules and associated enabling technologies.
  6. Experience on solid oral and parenteral formulation development and manufacturing essential.
  7. Experience of authoring IMPD and/or IND modules.
  8. Thorough understanding of GMP and relevant regulatory guidelines.
  9. Professional membership (e.g. Academy of Pharmaceutical Sciences) desirable.
  10. Paediatric formulation development experience desirable.
  11. Experience of commercial primary and secondary packaging configuration desirable.
  12. Strong quality focus, experience in a GMP environment.
  13. Understanding of regulatory expectations and profound scientific knowledge in pharmaceutical development.
  14. Work collaboratively with energy and enthusiasm as part of a team and broader network.
  15. Self-motivated, able to identify opportunities for improvement, build a case for change and then lead the change implementation.
  16. Conscientious with a can-do attitude with excellent attention to detail.
  17. Comfortable operating in a business that is hands on, flexible and proactive and demonstrate Intellectual rigour, insightfulness and sound judgement.
  18. Excellent verbal, written and presentation skills.
  19. 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