Principal Formulations Chemist

Job Overview

Subject matter expert in the field of Formulation with focus on Early Stage Pharmaceutical Development. 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. The post holder must ensure that all work is carried out in accordance with the Company’s Quality Manual, Standard Operating Procedures and H&S requirements as well as those set by regulatory bodies globally. Additionally this role will mentor and coach formulation chemists to ensure adoption of best practices, including application of Quality by Design, Design of Experiments, Statistical analysis and support of pharmaceutical process development

Main Activities

• Lead Early stage Development and optimisation of Pharmaceutical Dosage Forms for Veterinary use, activities to include but not limited to:
• Assessment of API/excipients to identify Critical Material Attributes
• Identification and evaluation of Product Critical Quality Attributes
• Manufacturing Process development and identification and evaluation of Critical Process Parameters and capability of processes and equipment
• Lead Scale up and Tech Transfer of NPD projects into Late stage formulations
• Evaluation and justification of Product in process controls and specifications
• Prepare Pharmaceutical Development reports
• Preparation and support of submission documents and regulatory responses in consideration of (V) ICH guidelines, Ph. Eur., BP monographs and appropriate guidance documents such as CDER
• Mentoring and support of formulation chemists
• Preparation and maintenance of Standard Operating Procedures (SOPs) ensuring that Standard Operating Procedures and Formulation Records are being adhered to at all times

Essential Criteria:

• Degree in in chemistry, analytical chemistry, pharmacy or related subject
• At least 5 years demonstratable experience in formulation/pharmaceutical product development industry or academia
• Experience in the use of QbD principles for pharmaceutical 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 cross functionally
• Experience of physical test analysis

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.
• We are unable to sponsor or take over sponsorship of a Visa at this time.

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.