Job Reference: JO-1912-64901_1593505650
- 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
- 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
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