SEDA Talent
Formulations Chemist
SEDA Talent have partnered with a pharmaceutical manufacturer, to recruit for a Formulations Chemist to join their team in Co. Down. This company leads the field in veterinary products, their portfolio of products is distributed across the world, and they have a total commitment to innovation & quality and delivering value to their customers.
The Formulations Chemist will be responsible will be responsible for the development of a pharmaceutical product from target product profile to prototype manufacture and supporting technology transfer to manufacturing suites
Responsibilities
- Development and optimisation of pharmaceutical dosage forms.
- Identification and evaluation of Product Critical Quality Attributes through risk assessment
- Manufacturing Process Development and
- Assessment of Critical Material Attributes of API/excipients
- Support Scale up and Tech Transfer of NPD projects into Operations
- Perform laboratory-based manufacture and analysis to drive formulation/product development
- Preparation and support of submission documents and regulatory response in consideration of (V) ICH guidelines, Ph. Eur., BP, USP monographs and appropriate guidance documents such as CDER
- Evaluation and justification of product in-process controls and specifications including compilation of a control strategy
- Lead preparation of Pharmaceutical Development reports in support of Regulatory submissions
- Maintenance of accurate records, preparation of protocols and reports for both group and R&D management
- Preparation and maintenance of Standard Operating Procedures (SOPs) and ensuring SOPs and Formulation Records are being adhered to at all times
- Training and mentoring of laboratory staff in SOP’s, manufacturing processes and operation techniques
- Liaise with staff across R&D and partner groups in Operations and QC to effectively progress new product development and continuous improvement initiatives
Ideal Candidate
- Bachelor’s Degree in a chemistry or pharmacy related discipline
- At least 3 years’ hands on experience related to formulation and product development
- Excellent computer skills including Microsoft Office suite in particular ability to trend data using an appropriate statistical package e.g. Minitab, Excel
This role comes with a comprehensive rewards package, for more details please apply directly below or Call the Team at SEDA Talent today on 02896016225
