Looking to uncover insights that could revolutionize the future of medicine and drive breakthroughs in patient care?
Proclinical is seeking an Analytical Research Expert to support Analytical Research and Development (ARD) within the pharmaceutical development space. This role focuses on the characterization and analysis of small molecule drug substances and drug products. You will play a key role in driving method development, managing analytical activities, and supporting regulatory submissions.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Plan, analyse, and report results of scientific experiments for timely supply of drug substances and drug products.
- Write and review analytical documents, including methods, specifications, validation reports, stability reports, and batch records.
- Drive method development for peptide drug substances and radioligand therapy (RLT) drug products.
- Manage interactions with internal and external stakeholders, including outsourced activities to CROs, providing scientific and technical guidance.
- Identify scientific, technological, and GMP challenges, propose solutions, and communicate key issues to project leaders or teams.
- Ensure compliance with SOPs, GMP, quality directives, health and safety standards, and internal guidelines.
- Provide input to analytical CMC documents and support regulatory submissions.
- Lead analytical activities such as impurity profiling, method development, validation, stability, and release testing for RLT compounds.
- Offer scientific guidance to cross-functional and global project teams, driving the RLT portfolio.
- Collaborate effectively with project teams, stakeholders, and partners.
Key Skills and Requirements:
- Advanced degree in analytical chemistry or equivalent.
- Strong understanding in parenteral development, peptide analytics, and RLT dosage forms.
- Proficiency in documentation writing, including stability reports, validation, and regulatory modules.
- Broad scientific knowledge in chemistry, pharmaceutical, or analytical sciences.
- Experience with laboratory tools such as HPLC, LC-MS, and statistical evaluation tools.
- Familiarity with quality management systems and commonly used software.
- Excellent scientific and technical writing skills.
- Leadership experience in guiding and mentoring colleagues.
- Strong coordination skills, collaborative spirit, and self-driven attitude.
- High level of learning agility and quality focus.
- Fluent in English, both oral and written.
If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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