Head of Pharmaceutical Development - Formulations

Job Overview

To lead the R&D Pharmaceutical Development Formulations team (Early and Late stage Formulations, and the Formulations Analytical Laboratory) in the development, scale-up and characterisation of new product formulations. All activities will be executed in accordance with the Company’s Quality Manual, Standard Operating Procedures, and the quality standards set by the company.

Main Activities/Tasks

• To provide strategic leadership to the Formulation’s teams in the support of new product introduction
• To act as primary contact for assessment of all new candidates for new product development including provision of costings for the conduct of all associated work
• Development of chemical and physical analytical methods to support early stage product development
• To support and implement the QbD approach to Pharmaceutical Development
• Identification and evaluation of product Critical Material Attributes (CMAs)
• Identification and evaluation of Critical Process Parameter (CPPs)
• Development of robust, scalable Manufacturing Processes
• Reverse engineering of commercial reference products
• Manage, inspire and lead the teams, providing clear and focussed direction to ensure goals and objectives are met or if possible, exceeded in accordance with quality, regulatory and contractual standards.
• Manage manufacture of products for clinical evaluations and ensure on time delivery of test articles
• To drive risk analysis in support of the Tech Transfer process within the Pharmaceutical Department in regard to formulations, manufacturing processes and formulations analytical methods
• To support the introduction and maintenance of key performance indicators within Pharmaceutical Development – Formulations delivering projects on time and on budget
• To drive capacity analysis within the Pharmaceutical Development Formulations teams to ensure optimal and efficient use of resources and equipment
• Work closely with other R&D Management Team members to ensure project goals are met to the right quality, cost and on time.
• Working cross-functionally, establish appropriate practices to continuously improve personal and team performance.
• Actively manage performance review process to retain staff and improve skills within group
• Play a key role representing Chemistry, Manufacturing and Control on Project Teams.
• To support the compilation of budgets for the Pharmaceutical Development Formulations teams and to ensure continual review of actual spend vs budget
• Adopt proactive approach to problem solving, recommending or applying novel or innovative solutions taking a leading role in troubleshooting technical issues cross functional.
• Support preparation and review of technical documents and Standard Operating Procedures where required.
• Support compilation and review of CMC sections of regulatory dossiers and where required provide technical input to regulatory queries.
• 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.
• Where appropriate manage interface with contract facilities. Liaise with legal team and quality function to establish appropriate contracts and technical agreements. Ensure progress is maintained on each programme to meet defined timelines and that all activities are performed in accordance with quality and contractual standards.
• To ensure all work undertaken within the group complies to current guidance (USP, Ph Eur, (V)ICH), and industry best practice.
• To oversee Formulations manufacturing and formulations analytical Laboratories and ensure they are kept in a state of audit readiness at all times
• To maintain an awareness of current trends and developing technologies in the manufacture of pharmaceutical dosage forms and analytical methods
• Provide required governance ensuring resources are accurately logged within the Timesheet system.
• To conduct 1:1 meetings with all direct reports and take responsibility for performance management
• Drive a culture of ownership and accountability empowering all direct reports to manage and develop their teams to their full capability
• Any other duties as deemed necessary by Management.

Essential Criteria:

• Educated to at least PhD level in Pharmacy, Chemistry or Pharmaceutical Sciences
• A minimum of 10 years relevant experience within the pharmaceutical industry. Specific experience working within pharmaceutical product development or a process/manufacturing environment.
• At least 5 years’ experience managing a large team of people encompassing formulation and analytical capability
• An excellent understanding of technologies (and challenges) associated with formulation and process development over a range of dosage forms
• Competent in chemical and physical analytical methodology and testing procedures necessary for the development and approval of successful formulations
• Technical expert in dosage form development of orals and injectables
• Extensive proven knowledge of requirements associated with technical transfers to Manufacturing Operations.
• Proven project management, planning and influencing skills.
• Effective written and verbal communication skills.
• Experience of working to current Good Manufacturing Practice and/or Good Laboratory Practice and implementing policies and procedures in line with regulatory guidelines.

Desirable Criteria:

• Knowledge, understanding and/or application of AI within formulation development.
• Experience in in-vitro method development to demonstrate in-vitro/in-vivo correlations
• A minimum of 15 years relevant experience within the pharmaceutical industry.
• Fully conversant in EU and US regulatory landscape .

Duration: Full time, 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.

Contact: [email protected]

Norbrook 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.