Head of Late Stage Formulations

Walker Cole International is partnering with a leading pharmaceutical company in their search for a Head of Late Stage Formulations.

This senior technical leadership role combines hands-on formulation expertise with people management. You'll lead the Late Stage Formulation team, develop and optimise formulations for new products using QbD principles, and make sure they're robust, scalable and ready for commercial manufacture.

Key responsibilities

• Lead late-stage formulation development studies for drug products in line with current ICH guidelines.
• Take small-scale lab processes from early-stage development through scale-up and technology transfer.
• Apply QbD principles to build process understanding, strengthen risk assessments, and define and lock down critical process parameters (CPPs).
• Work with Operations, Quality and other teams to support scale-up and the handover of new products into manufacturing.
• Oversee reverse engineering, product characterisation and stability studies.
• Write and review technical documents, including protocols, reports and batch records, to support regulatory submissions and responses.
• Give technical input on patents and IP, and build links with universities and external partners.
• Lead, develop and train the team, keeping laboratory work to high quality and safety standards.

Experience and qualifications

• A postgraduate degree in Chemistry, Pharmaceutical Sciences, Pharmacy or a related field.
• At least 5 years' experience in drug product formulation development, manufacture and scale-up across a range of dosage forms.
• Working knowledge of GMP and regulatory requirements, including FDA, EMA and ICH.
• A proven record of leading, developing and motivating scientific teams.
• Strong communication skills and experience working across functions.

Formulation Development | Late Stage Development | Drug Product | QbD | CPPs | Scale-Up | Technology Transfer | Stability Studies | Regulatory Submissions | ICH | GMP | Team Leadership