Head of Pharmaceutical Development – Formulations
Job Overview:
Are you ready to take the lead in shaping the future of pharmaceutical formulations? We’re seeking a dynamic Head of Pharmaceutical Development – Formulations to spearhead innovation and excellence in our R&D Pharmaceutical Development team. This pivotal leadership role covers Early and Late-Stage Formulations and the Formulations Analytical Laboratory. You’ll oversee the development, scale-up, and characterization of ground-breaking product formulations while ensuring adherence to top-tier quality standards and operational protocols.
Your Impact:
As the strategic leader, you’ll play a key role in driving innovation, fostering collaboration, and ensuring successful delivery of projects from concept to market. Your contributions will directly shape the trajectory of our product pipeline, supporting critical advancements in healthcare.
Key Responsibilities:
* Strategic Leadership: Inspire and guide our Formulations teams to deliver new product introductions with excellence.
* Innovative Product Development: Assess new product candidates, reverse-engineer commercial products, and implement Quality by Design (QbD) principles to develop robust, scalable formulations and manufacturing processes.
* Analytical Mastery: Develop cutting-edge chemical and physical analytical methods for early-stage products and ensure thorough characterization of Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs).
* Tech Transfer Expertise: Lead risk analysis and ensure seamless transfer of formulations, manufacturing processes, and analytical methods to operational teams.
* Operational Excellence: Manage resources, conduct capacity analysis, and establish performance indicators to ensure on-time, within-budget project delivery.
* Collaborative Leadership: Work cross-functionally to optimize performance, troubleshoot technical issues with innovative solutions, and drive team ownership and accountability.
* Regulatory Leadership: Contribute to Chemistry, Manufacturing, and Control (CMC) submissions, regulatory dossier reviews, and address regulatory queries with precision.
* Safety and Compliance: Champion a safe working environment and ensure compliance with industry best practices and regulatory standards.
Essential Qualifications:
* Educational Foundation: PhD in Pharmacy, Chemistry, or Pharmaceutical Sciences.
* Industry Experience: Over 10 years in pharmaceutical product development or manufacturing, with 5+ years managing large, multidisciplinary teams.
* Technical Mastery: Strong understanding of formulation technologies across dosage forms, with proven expertise in oral and injectable product development.
* Regulatory and Quality Knowledge: Demonstrated experience with GMP, GLP, and global regulatory environments.
* Leadership Skills: Exceptional project management and team development capabilities, with excellent communication and decision-making skills.
Desirable Additions:
* Familiarity with AI-driven formulation development.
* Advanced expertise in in-vitro/in-vivo correlations.
* Over 15 years in the pharmaceutical industry with comprehensive knowledge of EU and US regulations.
Additional Information:
* Full-time, permanent role with flexibility to work from home.
* 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.
* Visa sponsorship is not available for this role.