Description:
We are looking for a Process Scientist to join our Technical Operations Team in Cork. The Process Scientist provides technical support and program management to Oral Solid Dosage (OSD) manufacturing operations, working as part of the Site Technology team and reporting to the Site Technology Manager. This is a 24 month fixed term contract.
Responsibilities:
- Provide technical support for the manufacture of existing OSD products.
- Troubleshoot and resolve complex manufacturing or technical issues by facilitating data-driven decision making.
- Identify and implement process, technology, and cost improvements across the product portfolio.
- Support all stages of the product lifecycle, including development, regulatory registration, clinical, and commercial manufacture.
- Support and, where applicable, lead programs for the introduction of new products into the commercial facility.
- Support the execution of validation activities within Site Technology’s scope.
Qualifications
- Third level degree or higher in Chemistry, Biotechnology, Engineering, or a related scientific discipline.
- 3+ years’ experience in manufacturing and/or process chemistry, with a background in batch processing, technology transfers, scale-up, commissioning and validation within a cGMP pharmaceutical environment.
- Detailed knowledge of cGMP and regulatory requirements related to pharmaceutical manufacturing preferred.
- Proven project management skills with a track record of delivering projects on schedule, within budget, and to predefined quality requirements.
- Demonstrated problem-solving ability.
- Strong technical writing and project management skills.
- Collaborative mindset with a willingness to take ownership of initiatives.
- Effective communication skills with experience building partnerships with both internal and external stakeholders.
- Experience applying Quality by Design (QbD) principles and risk assessment tools.