We are currently recruiting for an experienced Head of Analytical Development to join our team in Q2/Q3 2020. The role is offered on a permanent, full-time basis however there is possible flexibility in hours for the right candidate. Work location is also flexible however the individual will be expected to travel to our offices in Eccles and to meetings at other locations within the United Kingdom and Europe as required. The successful candidate will be responsible for technical leadership of the analytical development of NME currently in late stage clinical development. This is a rare opportunity to join a company developing a truly novel drug to treat unmet medical need where you will be able to grow and further develop your own knowledge and expertise.
- Accountable for technical leadership of the analytical 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, stability protocols 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 F2G’s 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 or analytical chemistry.
- 10+ year experience in analytical development roles working in both drug substance and drug product.
- Phase 3 and/or new product introduction (launch)
- NDA/MAA module authorship desirable
- QbD experience desirable
- Proven experience of delivery through CMOs.
- Experience of authoring IMPD and/or IND modules.
- Thorough understanding of GMP and relevant regulatory guidelines.
- A sound knowledge of and a proven background in developing, validating and troubleshooting chromatographic methods and dissolution test procedures.
- Experience in designing regulatory acceptable stability studies supporting late stage clinical development leading to NDA / MAA.
- Experience in establishing and justifying small molecule product specifications for clinical release, shelf life and re-test periods, leading to NDA / MAA.
- Knowledge of drug substance and drug product development and manufacture is desirable
- Knowledge of establishing and qualifying reference materials is desirable.
- Professional membership (e.g. Royal Society of Chemistry) 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