Job Description
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.