Head of Pharmaceutical Development – Formulations

​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.