Head of Pharmaceutical Development – Formulations

Job title:

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 .