Head of Early-Stage Formulations

Head of Early-Stage Formulations Overview

A leading global pharmaceutical manufacturing organisation is seeking a Head of Early-Stage Formulations to lead its team within R&D. This role is responsible for defining and executing formulation development strategies for new veterinary drug products, from pre-formulation through to late-stage development and scale-up.

The successful candidate will act as a technical expert in formulation science, applying Quality by Design (QbD) principles and regulatory best practices to accelerate development timelines while ensuring robust, compliant product design.

Key Responsibilities

• Lead the design and execution of early-stage formulation studies for veterinary drug products in line with current (V)ICH guidelines
• Apply API physicochemical data to support formulation and process development strategies
• Define and evaluate Critical Quality Attributes (CQAs) using structured risk assessments and QbD principles
• Identify, optimise, and evaluate Critical Process Parameters (CPPs) to ensure robust, science-driven formulation development
• Transfer laboratory-scale formulations and processes to late-stage development and manufacturing for scale-up and commercialisation
• Collaborate with formulation analytics teams to support early-stage analytical method development
• Initiate and oversee prototype stability programmes to enable early formulation progression
• Work closely with Regulatory Affairs to ensure alignment with agreed regulatory strategies and timely dossier submissions
• Drive continuous improvement initiatives to accelerate early-stage formulation development
• Maintain awareness of patents and intellectual property considerations impacting product development, providing technical input to IP strategy
• Lead, develop, and mentor scientific staff, ensuring skills development and effective team performance

Essential Criteria

• Postgraduate degree in a relevant discipline (e.g. Chemistry, Pharmaceutical Sciences, Pharmacy, or related field)
• Minimum 5 years' experience in drug product formulation development, manufacturing, and analytical processes across a range of dosage forms (human or veterinary)
• Strong working knowledge of GMP and regulatory requirements, including FDA, EMA, and VICH/ICH guidelines
• Excellent IT skills, including proficiency in Microsoft Office
• Highly motivated, proactive individual with the ability to manage multiple priorities
• Strong communication skills with a proven ability to work cross-functionally

Demonstrated experience leading, developing, and motivating scientific teams