Head of Development

1 week ago

Newry, United Kingdom Next Phase Recruitment Full time

Head of Pharmaceutical Development – Formulations


Job Overview:

We are seeking a Head of Pharmaceutical Development – Formulations to lead our R&D Pharmaceutical Development team, including Early and Late-Stage Formulations, and the Formulations Analytical Laboratory. In this role, you will oversee the development, scale-up, and characterization of new product formulations. You will ensure all activities align with the company's Quality Manual, Standard Operating Procedures, and quality standards.


Key Responsibilities:

  • Provide strategic leadership to the Formulations teams to support new product introductions.
  • Act as the primary contact for assessing new product candidates and providing cost estimates for associated work.
  • Develop chemical and physical analytical methods for early-stage product development.
  • Implement the Quality by Design (QbD) approach in Pharmaceutical Development.
  • Identify and evaluate Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs).
  • Develop robust, scalable manufacturing processes.
  • Reverse engineer commercial reference products.
  • Manage and lead the teams to ensure goals and objectives are met in accordance with quality, regulatory, and contractual standards.
  • Oversee the manufacture of products for clinical evaluations, ensuring timely delivery.
  • Lead risk analysis to support the tech transfer process for formulations, manufacturing, and analytical methods.
  • Establish and maintain key performance indicators for delivering projects on time and within budget.
  • Drive capacity analysis within the team to optimize the use of resources and equipment.
  • Work cross-functionally to improve team performance and meet project goals.
  • Conduct performance reviews to retain and enhance staff skills.
  • Play a key role in Chemistry, Manufacturing, and Control (CMC) on project teams.
  • Prepare budgets for the Formulations teams and monitor spending against budgeted costs.
  • Troubleshoot technical issues using innovative solutions.
  • Support the preparation and review of technical documents and Standard Operating Procedures.
  • Contribute to the compilation and review of CMC sections of regulatory dossiers and address regulatory queries as needed.
  • Ensure a safe working environment in line with Health and Safety requirements.
  • Manage interfaces with contract facilities and maintain progress on programs, ensuring adherence to quality and contractual standards.
  • Ensure all work complies with current guidelines (USP, Ph Eur, (V)ICH) and industry best practices.
  • Oversee the audit-readiness of the Formulations and Formulations Analytical Laboratories.
  • Maintain an awareness of trends and emerging technologies in pharmaceutical manufacturing and analytical methods.
  • Manage timesheet system resources and ensure proper logging of hours.
  • Conduct 1:1 meetings with direct reports and manage their performance.
  • Drive a culture of ownership and accountability within the team.


Essential Criteria:

  • PhD in Pharmacy, Chemistry, or Pharmaceutical Sciences.
  • Minimum of 10 years of relevant experience in the pharmaceutical industry, particularly in product development or manufacturing environments.
  • At least 5 years of experience managing large teams with formulation and analytical capabilities.
  • Strong understanding of formulation and process development technologies across dosage forms.
  • Competent in chemical and physical analytical methods for formulation development.
  • Expertise in dosage form development, particularly for orals and injectables.
  • Proven experience in technical transfers to Manufacturing Operations.
  • Strong project management and leadership skills.
  • Excellent written and verbal communication skills.
  • Experience with Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) and regulatory compliance.


Desirable Criteria:

  • Experience with AI applications in formulation development.
  • Expertise in in-vitro method development to demonstrate in-vitro/in-vivo correlations.
  • 15+ years of experience in the pharmaceutical industry.
  • Knowledge of EU and US regulatory environments.


Additional Information:

  • Full-time, permanent role.
  • Proof of the right to work in the UK is required.
  • This role is based at a site that produces penicillin products and may not be suitable for those with a penicillin allergy.
  • Applications received after the closing date will not be accepted. Visa sponsorship is not available for this role.

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