Head of Late Stage Formulations

Job ref: HOLS300926 Job type: Permanent Location: Newry Closing date: Wednesday 14 Oct 2026 17:00 Main Activities/Tasks Responsible for the development of Late-Stage formulation studies for veterinary drug products in accordance with relevant current (V)ICH guidelines. Transfer small-scale laboratory processes from early-stage development for scale-up and technology transfer. Apply quality by design principles to aid process understanding and strengthen risk assessments, while optimising and locking down critical process parameters (CPP) to ensure a robust, commercially viable manufacturing process. Liaise cross-functionally with Operations, Quality and other teams to support scale-up activities and ensure the smooth handover of new products and technologies into manufacturing. Responsible for reverse engineering activities, product characterisation and stability studies. To maintain an awareness of current trends and developing technologies, including collaborations with universities and external laboratories / partners. To maintain an awareness of the status of patents/intellectual property rights affecting the development of pharmaceutical products and provide technical input to the patent/intellectual property portfolio. Preparation and support of submission documents and regulatory response in consideration of (V) ICH guidelines, Ph. Eur., BP, USP monographs and appropriate guidance documents such as CDER. Authors and review of technical documents, such as protocols, reports, batch records in support of Regulatory submissions. To identify areas for continuous improvement within the team and bring to Head of R&D for review and approval To ensure that the Late Stage Formulation Section operate to a high quality standard, including the generation and adherence to appropriate SOP's and associated documentation Ensure a clean and safe working environment within the laboratories, following all COSHH and other Health and Safety requirements; liaise with the company Health and Safety teams as required in line with departmental and company-wide SOPs. Training of laboratory staff in SOP's, manufacturing processes and operation techniques and responsible for maintaining and reviewing team's training curriculum Any other duties as deemed necessary by management Essential Criteria: Post graduate Degree in a relevant field e.g. Chemistry, Pharmaceutical Sciences, Pharmacy related discipline. At least 5 years experience of drug product formulation development, manufacture, scale-up and analytical processes of a variety of dosage forms within human or veterinary. Excellent computer skills including Microsoft Office suite. Working knowledge of GMP and regulatory requirements, including FDA, EMEA, VICH/ICH regulations. Enthusiastic and hard-working individual, highly motivated to achieve technical targets. Ability to multitask. Strong communication skills with a demonstrable record of working cross functionally. Proven experience in leading, developing, and motivating scientific teams, with a strong track record of effective people management. Duration: Permanent Location: Newry Benefits: Free life assurance Company pension scheme Healthcare cash plan 32 days annual leave Wedding leave Company sick pay Employee well-being initiatives Employee assistance programme On-site free parking Subsidised canteen facilities WeCare programme - supporting the local community Employee perks scheme Employee recognition scheme Career development opportunities To Apply Please forward your CV via the APPLY Now button below. TPBN1_NI