CMC Statistician

We're seeking an experienced CMC Statistician to provide high-impact statistical support across the development and manufacturing of biological and gene therapy products. You'll be a key partner to process scientists, analytical experts, and regulatory teams - designing experiments, interpreting complex data, and ensuring that manufacturing and control strategies are scientifically and statistically sound. Key Responsibilities Design and analyze experiments (DOE) to optimize product and process development. Provide statistical input for method validation, process comparability, and robustness studies. Support specification setting, stability trending, and process control strategy. Prepare and review technical reports and statistical justifications for internal teams and regulatory submissions. Collaborate cross-functionally with R&D, Manufacturing, QA, and Regulatory Affairs. Mentor colleagues on the appropriate use of statistical tools and methodologies. Manage multiple CMC projects simultaneously while meeting agreed timelines. What You'll Bring MSc or PhD in Statistics 2 - 4 years' experience as a Statistician within pharmaceutical or biotech development. Proven expertise in: Design of Experiments (DOE) Regression and variance analysis Process capability & control charts Multivariate and equivalence testing Proficiency with R, JMP, and/or SAS; knowledge of Python is a plus. Interested? Apply now for immediate consideration or contact Lloyd Broomes – LBroomes@planet-pharma.co.uk We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Business providing Global Staffing services.