Early Stage Formulations Chemist TLNT1_NI in Newry

The role involves the early-stage development and manufacture of veterinary pharmaceutical dosage forms, from pre-formulation through to regulatory submission, while ensuring compliance with VICH Guidelines and the Pharmaceutical Section Policy Document. The successful candidate will apply Quality by Design (QbD) principles and development strategies, ensuring adherence to global regulatory requirements and industry standards. The position offers the opportunity to work within a multidisciplinary team of scientists involved in the development of a broad range of pharmaceutical dosage forms, including oral tablets, suspensions and solutions, sterile injectable suspensions and solutions, topical formulations, and intra-mammary preparations.

Main Activities

• To develop and manufacture veterinary pharmaceutical dosage forms, from pre-formulation through regulatory submission, whilst adhering to the quality standards outlined in VICH Guidelines and the Pharmaceutical Section Policy Document.
• 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.
• Development and optimisation of manufacturing process for routine manufacture of pharmaceutical dosage forms.
• Provide support for Continuous Improvement efforts for existing products.
• Perform physical chemical analysis of API and drug product for new and existing projects.
• Assist development and validation of analytical methods for new and existing products.
• Assist with reverse engineering of commercial products.
• Develop product specifications for new products.
• Prepare Pharmaceutical Development reports in support of Regulatory submissions.
• Maintain accurate records and prepare reports for both group and R&D management.
• Ensure compliance with SOPs and GxP requirements.
• Prepare and maintain Standard Operating Procedures.
• Ensure proper maintenance of equipment including validation, cleaning and calibration as required.
• Train laboratory staff in SOP's and operation techniques.

Essential Criteria:

• Bachelor's degree (or higher) in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related scientific discipline.
• Minimum 2-3 years of hands-on experience in pharmaceutical drug product development and/or manufacturing within a research or pharmaceutical industry environment.
• Working knowledge of GMP and ICH/(V)ICH guidelines and regulatory requirements.
• Competent user of Microsoft Office applications, including Word, Excel, and PowerPoint.
• Experience in data analysis, trend identification, and interpretation.
• Strong written and verbal communication skills.
• Ability to work effectively within cross-functional teams in a regulated environment.

Desirable Criteria:

• Postgraduate qualification (MSc or PhD) in a pharmaceutical or chemistry-related discipline.
• Experience supporting ANDA and/or regulatory submissions.
• Knowledge and practical application of Quality by Design (QbD) principles.
• Experience using statistical analysis software such as Minitab or Design Expert.
• Experience in formulation development of solid and/or liquid oral dosage forms and/or sterile products.
• Understanding of pharmaceutical scale-up and technology transfer activities.

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.

To Apply, please forward your CV via the APPLY Now button below.