Head Of Late Stage Formualtions

Job Overview

The successful candidate will be a technical expert in the field of formulation development to manage the Late-Stage Formulation team. Responsible for developing and optimising formulations for new veterinary pharmaceutical products taking account of quality by design principles, ensuring robustness, scalability, and readiness for commercial manufacture. Managing technical risk and cross-functional coordination is a key element of the role.

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. 

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

Additional Information:

• 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.
• We are unable to sponsor or take over sponsorship of a Visa at this time.
• This role is based on a site that produces penicillin and as such, would not be suitable for those with a penicillin allergy.

Contact: recruitment@norbrook.co.uk

Norbook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community.