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Product Development Manager

Quality & Laboratory
Dublin
Therese Keohane
Permanent
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Job Reference: JO-1912-64901_1593505650

Summary:


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


Minimum 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 time management skills are essential.

  • Results and Performance driven

  • Desirable Skills

  • Prior experience in designing preclinical studies and liaising with CROs




Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.


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Talent Consultant:
Therese Keohane
Therese Keohane
Business Unit Lead
Quality & Laboratory
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