Science, Pharmaceutical & Food

R&D Manager

  • Full Time
  • Remote
  • Dublin City Centre
  • 41828752

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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