Job title:
Formulations Chemist
Company
Norbrook Laboratories
Job description
Job Description:Development of veterinary pharmaceutical dosage forms. The successful candidate will be responsible for the development of a pharmaceutical product from target product profile, to prototype manufacture and supporting technology transfer to manufacturing suites. The holder of the role will employ quality by design principles whilst adhering to the quality standards outlined in VICH Guidelines and the relevant requirements set by regulatory bodies globally.Main Activities/Tasks
- Development and optimisation of Pharmaceutical dosage forms for veterinary use to include, but not limited to, oral tablets, suspensions and solutions, sterile injectable suspensions and solutions, topical suspensions and solutions, and intra-mammary preparations.
- Identification and evaluation of Product Critical Quality Attributes through risk assessment
- Manufacturing Process Development and Optimisation including identification and evaluation of Critical Process Parameters
- 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
- Other duties as requested by management
Essential Criteria:
- Bachelor’s Degree in a chemistry or pharmacy related discipline
- At least 3 years’ experience, post undergraduate qualification, in industry or academia 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
- Enthusiastic and hard-working individual, highly motivated to achieve technical targets with ability to multitask
- Strong problem solving and troubleshooting skills
- Strong communication skills with a demonstrable record of working as a team and cross-functionally
- Experience of physical test analysis
Desirable Criteria:
- Masters or PhD in pharmaceutical sciences
- Working knowledge of GMP and (V)ICH requirements
- Experience in new product introduction
- Experience of supporting ANDA regulatory submission
- Experience of Quality by Design
Additional Information:
Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.
We regret that applications received after the closing date and time will not be accepted.
Expected salary
Location
Newry
Job date
Sat, 12 Oct 2024 05:36:14 GMT
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