The R&D Manager will take responsibility for leading all R&D activities including formulation development and analytical development / validation
SPECIFIC RESPONSIBILITIES
- Develop and manage the R&D function to support the company operations, including but not limited to:
- Formulation Development
- Analytical Method Development
- Analytical Method Validation
- Assist in Manufacture / Sampling / Testing of Clinical / Pivotal Stability batches
- NPI Transfer / Scale-up of products
- Lead the day to day activities of R&D function to ensure delivery of the goals and objectives of the function.
- Develop and manage the R&D documentation and reporting systems so that R&D activities are effectively documented and reported.
- Provide technical guidance and training to R&D group.
- Liaise with other departments including Laboratory, QA, Production as appropriate to ensure delivery of the R&D programme.
- Assist in the introduction and development of new technologies and equipment to support NPI from R&D into clinical / commercial as required.
- Assist with external R&D collaborations and with the evaluation of the R&D pipeline including input to feasibility, regulatory strategy and clinical strategy.
- Provide regulatory input and assistance including generation of regulatory submission documentation
- Provide assistance and liaise with the external consultants on the IP strategy, including preparation of documentation for patent applications, as appropriate.
- Assist with the preparation of reports and other documents to support funding support applications including grants, R&D tax credit applications etc.
- Submit monthly reports to summarise progress, key challenges and issues to be addressed.
- Manage the R&D budget.
KEY SKILLS / EXPERIENCE REQUIREMENTS
Degree in Pharmacy or Chemistry or similar qualification.
5+ years R&D formulation experience in pharmaceutical GMP environment, preferably within oral, non-sterile dosage forms
Relevant analytical experience is desirable but not essential
Knowledge and experienced of equipment used for the manufacturing of Drug Product.
Highly flexible, works well in a team environment, and has necessary skills to organize, mobilize, communicate, influence and lead.
Excellent critical thinking and problem-solving abilities.
Excellent Project Management Skills
Strong interpersonal and communication skills
Experience in leading, managing and motivating teams
Interested? Send an up to date CV to Sean.Barron@peglobal.net or call 0214297900 for more information.
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