Company: Biopharmaceutical Contract Research Organization (CRO)
Location: Manchester, United Kingdom
About Us: A Biopharmaceutical Contract Research Organization (CRO) in Manchester is dedicated to advancing scientific research and innovation in the biotechnology and pharmaceutical industries.
They provide comprehensive GMP analytical and research services to support client biopharmaceutical development efforts.
They are seeking a highly motivated and skilled chromatography scientist to join their team and contribute to cutting-edge research projects.
Position Overview: As a chromatography scientist at our CRO, you will play a crucial role in supporting client research by utilizing various chromatographic techniques such as SEC-HPLC, RP-HPLC, and IEX, alongside other analytical methods.
Your primary responsibilities will include method development, optimization, and validation, as well as the analysis of biopharmaceutical samples to ensure high-quality data generation.
- Chromatographic Method Development:
- Develop and optimize chromatographic methods (SEC-HPLC, RP-HPLC, IEX, etc.) for the analysis of biopharmaceutical samples.
- Collaborate with clients and internal teams to tailor methods to specific project requirements.
- Method Validation:
- Perform method validation studies according to regulatory guidelines (ICH, FDA, etc.).
- Generate validation protocols and reports, ensuring compliance with industry standards.
- Sample Analysis:
- Execute analytical assays using various chromatographic techniques on client samples.
- Maintain detailed and organized records of sample analysis and results.
- Instrument Maintenance:
- Perform routine maintenance and troubleshooting of analytical instrumentation.
- Coordinate instrument calibration and qualification activities.
- Data Analysis and Reporting:
- Analyze and interpret analytical data, providing accurate and reliable results to clients.
- Prepare comprehensive reports summarizing analytical findings and data.
- Quality Assurance:
- Adhere to strict quality control and quality assurance procedures.
- Ensure compliance with regulatory guidelines and documentation standards.
- Collaborate with cross-functional teams, including research scientists and project managers, to meet project objectives and timelines.
- Actively participate in project meetings and discussions.
- A Bachelor's or Master's degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field.
- Prior industry experience utilising these chromatographic techniques including SEC-HPLC, RP-HPLC, and IEX.
- Proficient in data analysis software and analytical instrument operation.
- Excellent communication skills and the ability to work effectively in a collaborative team environment.
- Detail-oriented with a strong commitment to data integrity and quality.
- Experience with biopharmaceutical analysis, including proteins antibodies and Antibody-drug conjugates
- Knowledge of software for chromatographic data analysis (e.g., Empower, Chromeleon).
- Familiarity with GMP and GLP principles.
- Hands on experience with method development, optimization, and validation to ICH guidelines
- Competitive salary commensurate with experience.
- Comprehensive benefits package, including healthcare and retirement plans.
- Opportunity for professional development and growth within the organization.
- A collaborative and innovative work environment focused on advancing scientific knowledge.