Product Development Manager

Product Development Manager
Posted 2 months ago

The Role

The Product Development Manager will be based at the Dublin facility and this is a permanent role.

Principle Duties

The successful candidate will be involved in

  • Coordinate and manage multiple early-stage product development projects from preclinical up to Phase 1 clinical supply stage
  • Manage product development labs and manufacturing Phase 1 suite and all respective procedures and processes
  • Lead projects/processes – planning and delegating activities; time management
  • Manage product development team in overcoming technical challenges and developing pharmaceutical products in accordance with regulatory guidelines
  • Lead team developing formulations and processes suitable for manufacturing clinical trial supplies (IMPs) in cooperation with other relevant functions (e.g. analytical, QA, clinical groups)
  • Manage outsourcing of preclinical studies (GLP and non-GLP as required) for inclusion in Regulatory submissions. Develop and implement pre-clinical development plans and update as necessary
  • Oversee technical transfers of specified unit operations to support later stage clinical development (from Phase 2 on)
  • Responsible for the filings of high quality CMC dossiers
  • Promote scientific and entrepreneurial thinking, encourage creativity and manage quality and results with respect to science, time, budget and resources
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable while ensuring high level of morale in the CMC team
  • Ensure all work is carried out in compliance with company and regulatory standard
  • Communicate progress on actions to senior management and escalating issues as required
  • Good working knowledge of Microsoft Word, Excel, Powerpoint
  • Willingness to learn and ability to adapt to the needs of the business
  • Good interpersonal and team working skills
  • Strong written and verbal communication skills
  • Demonstrates a positive attitude to work and uses time efficiently and effectively

Minimium Requirements

  • Life Sciences Degree with minimum 3-5 years’ experience leading teams within a CMC/product development function required;
  • Experience, with past history of significant accomplishments, to effectively manage and direct product development activities with respect to science, technology, quality, regulatory and compliance requirements, budget and resources highly preferred.
  • CMC interdisciplinary experience and expertise
  • Knowledge of pharmaceutical theory and the drug development process
  • Strong knowledge of GMP requirements
  • Proactive, innovative with good problem-solving skills.
  • Excellent interpersonal, collaborative, communication (written and verbal) and timemanagement skills are essential.
  • Results and Performance driven

Desirable Skills

  • Prior experience in designing preclinical studies and liaising with CROs

How to apply

Suitable Candidates should submit a CV and cover letter by close of business, January 6th, 2020 to

The salary is negotiable and dependant on the experience of the successful candidate

Apply Online