Head of Pharmaceutical Development – Formulations

Job title:

Head of Pharmaceutical Development – Formulations

Company:

Norbrook Laboratories

Job description

Job Description:

• 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 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
• Support the introduction and maintenance of key performance indicators within Pharmaceutical Development – Formulations delivering projects on time and on budget
• 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.
• Play a key role representing Chemistry, Manufacturing and Control on Project Teams.
• Support the compilation of budgets for the Pharmaceutical Development Formulations teams and to ensure continual review of actual spend vs budget
• Support compilation and review of CMC sections of regulatory dossiers and where required provide technical input to regulatory queries.
• Ensure all work undertaken within the group complies to current guidance (USP, Ph Eur, (V)ICH), and industry best practice.
• Oversee Formulations manufacturing and formulations analytical Laboratories and ensure they are kept in a state of audit readiness at all times
• 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.
• 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.
• 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 .

Expected salary

Location

Newry

Job date

Wed, 16 Oct 2024 04:46:04 GMT

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