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Head of Pharmceutical Development

Contract Type: Permanent
Location: Unknown
Contact Name: Director of The RFT Group
Contact Email: gerry@rftgroup.ie

Job Description

Head of Pharmaceutical Development

Our client is a global leader in veterinary medicine. With an established presence in over 130 countries the business has grown dramatically over the past fifty years through a combination of outstanding innovation from its own research and development team as well as its own organic growth.

Head of Pharmaceuticals Development, offers an exciting opportunity to lead the R&D pharmaceutical development team (Formulations, Analytical Laboratories and R&D Technical Services) in the development, scale-up and characterisation of new product formulations and where required participate in the troubleshooting of product/method issues as part of lifecycle management. Leading a team of over 60 staff operating to GMP standards, all activities will be executed in accordance with the Company’s Quality Manual, Standard Operating Procedures, and the quality standards set by the company.

Job Spec

To provide strategic leadership to both formulation and analytical teams in the support of new product introduction and in the lifecycle management of existing products

To act as primary contact for assessment of all new candidates for development whether NP, LCM or business continuity, including provision of costings for the conduct of all associated work

To support and implement the QbD approach to Pharmaceutical Development

To identify areas for continuous improvement within the team and highlight to department

To oversee Pharmaceutical Development GMP Laboratories and ensure they are kept in a state of audit readiness at all times.

Oversee laboratory activities within the Formulations Laboratories to ensure SOPs, protocols, and where applicable principles of GMP are being adhered to.

To support the introduction and maintenance of key performance indicators within the Pharmaceutical Development GMP Laboratories and Formulation Laboratories.

To drive capacity analysis within the Pharmaceutical Development Department to ensure optimal use of resource.
  • To drive risk analysis in support of the Tech Transfer process within the Pharmaceutical Department in-regards-to formulations, manufacturing processes and analytical methods not limited to
    • Identification and evaluation of Critical Material Attributes (CMAs)
    • Reverse engineering of commercial reference products
    • Identification and evaluation of Product Critical Quality Attributes (CQAs)
    • Manufacturing Process Optimisation
    • Identification and evaluation of Critical Process Parameter (CPPs)
  • To support the compilation of budgets for the Pharmaceutical Development teams and to ensure continual review of actual spend vs budget
  • To lead an active role in troubleshooting technical issues cross functionally.
  • 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
  • Coordinate with partner lines to effectively progress new product development and maximize resources (staff and equipment)
  • To ensure all work undertaken within the group complies to current guidance (USP, Ph Eur, (V)ICH), and industry best practice.
  • To maintain an awareness of current trends and developing technologies in the manufacture of pharmaceutical dosage forms and analytical methods
  • Manage and mentor groups to ensure work is carried out in support of projects to agreed timelines
  • To conduct 1:1 meetings with all direct reports and take responsibility for performance management including PDP’s
  • 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.

Person Spec

Essential Criteria:
  • Degree in in chemistry, analytical chemistry, pharmacy or related subject
  • At least 10 years practical lab experience within a regulated environment with demonstrable experience in formulating both sterile and non-sterile dosage forms and demonstrable experience in developing and validating analytical methods
  • At least 8 years lab management experience within a regulated environment
  • Thorough understanding of pharmaceutical quality management systems
  • Experience in the use of QbD principles for pharmaceutical development
  • Knowledge of FDA/EMA practices and guidelines
  • Significant experience of HPLC, UPLC techniques
  • Experience in generating documentation to support the CMC component of regulatory filings
  • Experience in the setting of specifications for drug products
  • Experience in Technology Transfer with scale up from laboratory to commercial
  • General experience of clinical trials
  • Thorough understanding of pharmaceutical quality management systems
  • Excellent oral and written communication skills

Desired criteria:
  • Advanced degree in chemistry, analytical chemistry, pharmacy or related subject
  • Experience of managing multi-functional formulations and analytical teams and scheduling within these teams
  • Experience using the statistical software package Minitab
  • Experience supporting the lifecycle management of products
  • Experience of compiling/managing budgets
  • Significant experience in the trending and interpretation of analytical data
  • Experience of preparing responses to regulatory queries

CV to Gerry Kennedy The RFT Group gerry@rftgroup.ie 01 2302400
Head of Pharmaceutical Development

Our client is a global leader in veterinary medicine. With an established presence in over 130 countries the business has grown dramatically over the past fifty years through a combination of outstanding innovation from its own research and development team as well as its own organic growth.

Head of Pharmaceuticals Development, offers an exciting opportunity to lead the R&D pharmaceutical development team (Formulations, Analytical Laboratories and R&D Technical Services) in the development, scale-up and characterisation of new product formulations and where required participate in the troubleshooting of product/method issues as part of lifecycle management. Leading a team of over 60 staff operating to GMP standards, all activities will be executed in accordance with the Company’s Quality Manual, Standard Operating Procedures, and the quality standards set by the company.

Job Spec

To provide strategic leadership to both formulation and analytical teams in the support of new product introduction and in the lifecycle management of existing products

To act as primary contact for assessment of all new candidates for development whether NP, LCM or business continuity, including provision of costings for the conduct of all associated work

To support and implement the QbD approach to Pharmaceutical Development

To identify areas for continuous improvement within the team and highlight to department

To oversee Pharmaceutical Development GMP Laboratories and ensure they are kept in a state of audit readiness at all times.

Oversee laboratory activities within the Formulations Laboratories to ensure SOPs, protocols, and where applicable principles of GMP are being adhered to.

To support the introduction and maintenance of key performance indicators within the Pharmaceutical Development GMP Laboratories and Formulation Laboratories.

To drive capacity analysis within the Pharmaceutical Development Department to ensure optimal use of resource.


  • To drive risk analysis in support of the Tech Transfer process within the Pharmaceutical Department in-regards-to formulations, manufacturing processes and analytical methods not limited to
    • Identification and evaluation of Critical Material Attributes (CMAs)
    • Reverse engineering of commercial reference products
    • Identification and evaluation of Product Critical Quality Attributes (CQAs)
    • Manufacturing Process Optimisation
    • Identification and evaluation of Critical Process Parameter (CPPs)
  • To support the compilation of budgets for the Pharmaceutical Development teams and to ensure continual review of actual spend vs budget
  • To lead an active role in troubleshooting technical issues cross functionally.
  • 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
  • Coordinate with partner lines to effectively progress new product development and maximize resources (staff and equipment)
  • To ensure all work undertaken within the group complies to current guidance (USP, Ph Eur, (V)ICH), and industry best practice.
  • To maintain an awareness of current trends and developing technologies in the manufacture of pharmaceutical dosage forms and analytical methods
  • Manage and mentor groups to ensure work is carried out in support of projects to agreed timelines
  • To conduct 1:1 meetings with all direct reports and take responsibility for performance management including PDP’s
  • 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.

Person Spec

Essential Criteria:

  • Degree in in chemistry, analytical chemistry, pharmacy or related subject
  • At least 10 years practical lab experience within a regulated environment with demonstrable experience in formulating both sterile and non-sterile dosage forms and demonstrable experience in developing and validating analytical methods
  • At least 8 years lab management experience within a regulated environment
  • Thorough understanding of pharmaceutical quality management systems
  • Experience in the use of QbD principles for pharmaceutical development
  • Knowledge of FDA/EMA practices and guidelines
  • Significant experience of HPLC, UPLC techniques
  • Experience in generating documentation to support the CMC component of regulatory filings
  • Experience in the setting of specifications for drug products
  • Experience in Technology Transfer with scale up from laboratory to commercial
  • General experience of clinical trials
  • Thorough understanding of pharmaceutical quality management systems
  • Excellent oral and written communication skills

Desired criteria:

  • Advanced degree in chemistry, analytical chemistry, pharmacy or related subject
  • Experience of managing multi-functional formulations and analytical teams and scheduling within these teams
  • Experience using the statistical software package Minitab
  • Experience supporting the lifecycle management of products
  • Experience of compiling/managing budgets
  • Significant experience in the trending and interpretation of analytical data
  • Experience of preparing responses to regulatory queries


CV to Gerry Kennedy The RFT Group gerry@rftgroup.ie 01 2302400