Formulations Chemist

The holder of the role will utilise quality by design development strategies and adhere to the relevant regulatory requirements set by regulatory bodies globally.
Late-stage development and manufacture of veterinary pharmaceutical dosage forms, from Scale-Up, Technical Transfer, Pre-Approval through to regulatory submission.
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

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 Pharmacy, Pharmaceutical Sciences, Chemistry, or a related scientific discipline
• Minimum 2-3 year 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.
• Ability to work effectively within cross-functional teams in a regulated environment

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