| Description: | I am currently working with a major pharmaceutical organisation based in the North West. Please take time to read this advert.
Develop an understanding, constructive and interactive critique of all Development projects / programmes and an in-depth understanding of clinical development programmes, via informal and formal collaboration.
Demonstrate and excellent in-depth understanding of Good Manufacturing Practices (GMPs) in Product Development and Discovery of NCEs and biopharmaceuticals.
Develop a good understanding of contractual frameworks to govern practices at third party sub-contractors, to minimize risk to Renovo and maximize flexibility to accommodate programme and priority changes. Interact proactively and in a timely fashion with Research, Commercial and Financial Management in drawing up such agreements.
1. Establish validated manufacturing process with contractors / partners for bulk drug substance and / or finished product
2. Ensure FDA/EMEA approval of manufacturing dossiers
3. Establish scaled up manufacturing process with full documentation and validation for recombinant proteins and small molecules
4. Prepare CMC submissions for biological and chemical drugs
5. Global technical development planning, budgeting and coordination
6. Technology transfer from licensing partners and CROs
7. Technology transfer to manufacturing partners
8. Discussions with external consultants / bodies as appropriate
PRIOR EXPERIENCE & PERSONAL TRAITS:
1. Prior experience in Pharmaceuticals preparing CMC submissions for biotechnological and chemical drugs (IND/CTA/NDA/BLA and variations/SUPACs)
2. Experience with external manufacturers (including US)
3. Experience with biologics
4. Sound working knowledge of regulatory affairs and quality control
5. Relevant and recognised professional qualification
6. Ability to work within and lead a project team(s)
7. Proven track record in multi-disciplinary project team management / leadership
8. Ability to train / supervise junior staff; good team leadership / motivational skills
9. Excellent planning, time management and organisational skills
10. Excellent verbal and written communication skills
11. Excellent presentation skills
12. Solution orientated with excellent problem solving skills
13. Ability to negotiate and liaise with investigators / sub-contaactors and non-company people in a professional manner
14. Good computer skills with good working knowledge of a range of computer packages e.g., Microsoft Word, Excel, PowerPoint, Project, email
15. Demonstrate the ability to multi-task to a very high level
16. Highly self-motivated and proactive.
Please email your Cv for immediate consideration. |
