Job Description

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Job Overview

Late-stage development and manufacture veterinary pharmaceutical dosage forms, from Scale-Up, Technical Transfer, Pre-Approval through to regulatory submission. The holder of the role will utilise quality by design development strategies and adhere to the relevant regulatory requirements set by regulatory bodies globally. Working in a diverse team of scientists developing a wide range of Pharmaceutical Dosage Forms including but not limited to, oral tablets, suspensions and solutions, sterile injectable suspensions and solutions, topical suspensions and solutions, and intra-mammary preparations.

Main Activities

• Development and optimisation of Pharmaceutical dosage forms for veterinary use.
• Evaluation of critical material attributes of Drug Substance and Drug Product, employing risk assessment and quality by design principles.
• Materials Science background to support physical and chemical analysis of API and excipients
• Knowledge of a range of physico-chemical characterisation techniques and perform physical testing such as particle size, viscosity and spectroscopy
• Experience in method development and validation of physical methods
• Perform API technical reviews to support investigations and second sourcing program
• Work with external suppliers of API and excipients to support investigations and second sourcing program
• Assist with Reverse engineering of commercial reference products
• Support for Process development and Optimisation including identification and evaluation of Critical Process Parameters
• Support Remediation and Continuous Improvement efforts for existing products

Essential Criteria:

Applicants must therefore demonstrate the following essential criteria on their application form in order to be considered:

• Bachelor\xe2\x80\x99s Degree or higher in a chemistry physical and/or organic chemistry
• At least 3 years experience in industry or academia
• 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 cross functionally
• Experience of physical test analysis

Desirable Criteria:

Due to the nature of the role preference will be given to applicants demonstrating the following desirable criteria:

• Masters or PhD in a chemistry related discipline
• Working knowledge of GMP and (V)ICH requirements
• Experience in new product introduction
• Experience of supporting ANDA regulatory submission
• Experience of Quality by Design

Duration: Full time, permanent

Location: Newry

Additional Information:

This role will be based in a site that produces and handles penicillin, and as such, this role would not be suitable for those that have a penicillin allergy.
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.

Contact: recruitment@norbrook.co.uk

Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community.

Norbrook