Head of Development

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.