Head of Pharmaceutical Development - Formulations

We are delighted to be recruiting for this fantastic opportunity of Head of Pharmaceutical Development for Formulations with a global leader in the pharmaceutical industry based in Newry.

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

o Identification and evaluation of product Critical Material Attributes (CMAs)

o Identification and evaluation of Critical Process Parameter (CPPs) o Development of robust, scalable Manufacturing Processes

o 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

Essential Criteria:

Applicants must demonstrate the following essential criteria on their application form in order to be considered:

• 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:

Due to the nature of the role preference will be given to applicants demonstrating the following 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.
• This role is based in a site that produces penicillin products and as such would not be suitable for those with a penicillin allergy

We are unable to sponsor or take over sponsorship of a Visa at this time.

Benefits:

• Free Life Assurance
• Company Pension - salary sacrifice scheme
• Healthcare cash plan
• 32 days annual leave
• Wedding Leave
• Company Sick Pay
• Company Maternity / Paternity
• Paid bereavement leave
• Cycle to Work Scheme

• Tech Purchase Scheme

• Employee Savings scheme

• Employee well-being initiatives

• Employee Assistance Programme • On-site free parking

• Subsidised Canteen Facilities

• Employee Perks scheme

• Employee Recognition scheme

• Career development opportunities