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.

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