Advanced Analytical Method Development Specialist
il y a 7 jours
Job Title: Advanced Analytical Method Development Specialist
About the Role:
We are seeking an experienced Senior Analytical Scientist to join our team at Approach People Recruitment. As a key member of our analytical team, you will be responsible for leading the development, optimization, and implementation of robust analytical methods using UPLC/HPLC systems.
Key Responsibilities:
- Analytical Method Development: Design and conduct experiments to create reliable chromatographic methods, employing risk assessment and Quality-by-Design (QbD) principles when applicable.
- Data Analysis: Compile, interpret, and present scientific data to guide decision-making and ensure method robustness.
- Project Management: Oversee experiments and ensure timely completion, either independently or by coordinating with team members.
- Documentation & Compliance: Develop, validate, and document chromatographic methods in alignment with company quality standards and ICH guidelines.
- Technical Writing: Write, update, and review SOPs related to equipment use and analytical procedures.
- Collaboration: Actively collaborate with cross-functional teams, such as R&D, regulatory affairs, and process development, to meet project objectives.
- Knowledge Transfer: Support the transfer of analytical methods to internal teams or external partners (e.g., CDMOs).
- Continuous Improvement: Drive lab process improvements, adopt best practices, and expand analytical capabilities by evaluating new technologies.
- Client Interaction: Participate in client meetings and teleconferences, effectively communicating in English.
Qualifications:
- MSc in Analytical Chemistry, Chemistry, or a related field, with at least 5 years of experience in UPLC/HPLC method development and pre-validation within an R&D setting.
- Proficient in using Empower3 software.
- Knowledge of DoE methodologies (e.g., S-Matrix Fusion QbD or similar software) is advantageous.
- Familiarity with QbD principles for analytical method development and validation is a plus.
- Understanding of complementary analytical techniques, particularly mass spectrometry (MS), is desirable.
- Experience working in GMP/GLP-compliant environments and knowledge of ICH guidelines is an asset.
Salary: We offer a competitive salary range of $90,000 - $120,000 per year, depending on experience.
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