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