Head Of Early Stage Formulations

Job Overview

Norbrook are recruiting a technical expert in the field of formulation development to manage the Early-Stage Formulation team to create development strategies for new veterinary drug products within the R&D department. Conduct pre-formulation and manufacturing process development across a number of pharmaceutical dosage forms whilst adhering to the quality standards outlined in VICH Guidelines incorporating Quality by Design principles. Develop strategies to accelerate formulation development.

Main Activities

• Oversee the design and execution of early-stage formulation studies for veterinary drug products in accordance with relevant current (V)ICH guidelines.
• Applies key API physicochemical data to support development process.
• Lead the evaluation of product Critical Quality Attributes (CQAs), applying structured risk assessments and Quality by Design (QbD) principles including optimisation and evaluation of critical process parameters (CPP) to ensure robust, science driven formulation development.
• Transfer of small (lab) scale processes to late-stage formulations and operations for scale-up and commercialisation.
• Liaise with the formulation analytical team to support early-stage method development while initiating prototype stability programmes to enable early formulation progression.
• To liaise with Regulatory Affairs with regard to the regulatory requirements for new product development and follow agreed regulatory strategy making G submissions on time.
• Support Continuous Improvement efforts to accelerate early-stage development.
• To maintain an awareness and make timely submissions on the status of patents/intellectual property rights affecting the development of pharmaceutical products and provide technical input to the patent/intellectual property portfolio.
• Management of staff to ensure that they acquire, and apply, the skills necessary for undertaking their duties in an effective manner.

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 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: Full Time

Location: Newry, Co. Down

Remuneration: Salary Attractive

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.

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.