Head of Early Stage Formulations

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.
• To schedule priorities and plan experimental work to meet or exceed project milestones in collaboration with analytical and other CMC colleagues. Provide consistent updates to stakeholders on progress, emerging challenges, and any risks to timelines.
• Management of staff to ensure that they acquire, and apply, the skills necessary for undertaking their duties in an effective manner.
• To maintain an awareness of current trends and developing technologies, including collaborations with universities and external laboratories / partners.
• 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.
• Preparation and maintenance of Standard Operating Procedures.
• Responsible for maintaining and reviewing their own and teams training curriculum in line with departmental and company-wide SOPs.
• Adheres to departmental and Norbrook EH&S requirements.
• Training of laboratory staff in SOP’s, manufacturing processes and operation techniques.
• Any other duties as deemed necessary by management
• 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.
• 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.

Desired criteria:

• PhD in a Chemistry, Pharmaceutical Sciences, or pharmacy related discipline
• Experience of physicochemical testing.
• Experience in new product introduction.
• Experience of supporting ANDA regulatory submission.
• Experience of Quality by Design.
• Experience of Design of Experiments.

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…