Job Title: Analytical Development Scientist – Drug Substance
Location: Hull
Role Summary
We are seeking an experienced analytical development scientist to support drug substance development for new small molecule compounds.
The role involves ensuring analytical methodologies meet regulatory and quality standards throughout pre-clinical and clinical phases.
Key Responsibilities
* Lead analytical development activities for drug substance projects.
* Conduct or oversee analysis, method development, validation, transfer, and stability studies.
* Solve complex analytical challenges and contribute to process improvements.
* Maintain laboratory compliance with GMP standards and review data accordingly.
* Author and review analytical reports and regulatory documentation.
* Participate in project planning, risk assessments, and stakeholder discussions.
* Mentor and support junior team members.
Qualifications & Experience
* Degree in chemistry or a related field (2.1 or higher preferred).
* Analytical development experience in pharmaceuticals, with expertise in drug substance analysis.
* Strong proficiency in HPLC, HPLC-MS, GC, GC-MS, FTIR, Karl Fischer analysis, and statistical data software.
* Knowledge of regulatory guidelines (ICH, EMA, FDA) and Quality by Design principles.
* Experience working in a GMP environment.
Key Competencies
* Strong problem-solving skills and ability to develop innovative solutions.
* Self-motivated, results-oriented, and collaborative team player.
* Excellent communication and organizational skills.
Benefits
* 25 days holiday + public holidays
* Flexible working hours
* Pension contributions
* Health and wellbeing support
* Volunteer time off and employee discounts