Proclinical is seeking an Analytical Expert to support Analytical Research & Development (ARD). This role is crucial for the characterization and analysis of Small Molecule Drug Substances and Drug Products, from discovery to commercial production. The successful candidate will need to be a motivated individual with a strong background in parenteral development.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
- Plan, interpret, and report results of scientific experiments for timely supply of drug substances and drug products.
- Write and review analytical documents such as methods, specifications, validation reports, stability reports, and batch records.
- Manage interactions with internal and external stakeholders, including outsourced activities, providing scientific and technical guidance.
- Identify scientific, technological, and GMP challenges, propose solutions, and communicate key issues to the project team.
- Work according to SOPs, GMP, Quality Directives, Health and Safety guidelines.
- Contribute to analytical CMC documents and support regulatory submissions.
- Lead analytical activities including impurity profiling, method development, validation, stability, and release testing.
- Provide scientific guidance to cross-functional and global project teams.
- Foster a collaborative and inspired attitude within project teams and stakeholders.
Key Skills and Requirements:
- PhD/Master's Degree in analytical chemistry with proven industry experience in GMP drug development
- Expertise in HPLC, LC-MS, and analytical documentation.
- Experience in RLT or parenteral drug development; peptide analytics a plus.
- Broad scientific knowledge in chemistry and analytical sciences.
- Familiarity with commonly used software and computer tools.
- Strong scientific and technical writing skills.
- Eagerness to develop new methods and assess new analytical techniques.
- Proven leadership and mentoring abilities.
- Strong coordination skills, collaborative spirit, and self-driven attitude.
- High level of learning agility and quality focus.
- Excellent communication skills and fluency in English.
If you are having difficulty in applying or if you have any questions, please contact Joshua Bye at [email protected]
Apply Now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, 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.
