Formulations Chemist

Job Overview

Late-stage development and manufacture of 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
• Development and optimisation of manufacturing processes for routine manufacture of various pharmaceutical dosage forms employing Quality by Design principles
• Provide support for remediation/Continuous Improvement efforts for existing products
• Perform physical and chemical analysis and assessments of API and drug product for new and existing projects
• Assist with reverse engineering of commercial products
• Support Development of product specifications for new products
• Prepare Pharmaceutical Development reports in support of Regulatory submissions
• To ensure all equipment is adequately maintained and to carry out qualification, cleaning and calibration of equipment as required
• Preparation and maintenance of Standard Operating Procedures (SOPs) and ensuring SOPs and Formulation Records are being adhered to at all times
• Maintenance of accurate records, preparation of protocols and reports for both group and R&D management.
• To assist the regulatory affairs department in responses to regulatory bodies related to pharmaceutical development to ensure successful submission of new products.
• To ensure adequate stocks of consumables are available as required
• Other duties as requested by management

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

• Bachelor’s Degree or higher in a chemistry or pharmacy related discipline
• At least 1 years hands on experience of drug product development and/or manufacture
• Excellent computer skills including Microsoft Office suite
• Working knowledge of GMP and (V)ICH requirements

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

• Post Graduate Qualification in a chemistry or pharmacy related discipline
• Experience of supporting ANDA regulatory submission
• Experience of Quality by Design
• Use of statistical software e.g. Minitab

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.

Benefits:

• Free Life Assurance
• Company Pension Scheme
• Healthcare cash plan
• 31 days annual leave
• Wedding Leave
• Company Sick Pay
• Employee well-being initiatives
• Employee Assistance Programme
• On-site free parking
• Canteen Facilities
• Employee Perks scheme
• Discounted Car Insurance
• Annual Employee raffle
• Employee Recognition scheme
• Career development opportunities