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Position Overview
The Biologics Scientist specializing in Biophysical Characterization will serve as a key authority in the analysis of higher-order structure (HOS) and biophysical characterization of proteins and peptides, conducting independent research within the laboratory environment.
Key Responsibilities
- Utilize advanced techniques for the assessment of primary, secondary, and tertiary protein/peptide structures, employing methods such as amino acid analysis (AAA), N-terminal sequencing, circular dichroism (CD), FTIR, and/or DSC.
- Analyze protein quaternary structures and aggregates through techniques including SEC-MALS, svAUC, and/or DLS.
- Design, execute, and interpret experiments to generate independent data.
Method Development
- Engage in the development, validation, and transfer of analytical methods pertinent to biopharmaceutical products or raw materials.
Client Interaction
- Communicate findings effectively in meetings, ensuring clarity and conciseness.
Team Leadership
- Oversee the daily activities of junior analysts, ensuring timely completion of small to mid-sized projects that meet the expectations of both SGS and clients.
Technical Expertise
- Evaluate sophisticated analytical equipment or software, providing expert insights on quality and feasibility for laboratory applications.
- Develop and validate analytical testing procedures for drug substances and products.
Documentation and Reporting
- Prepare protocols, draft methods, and generate technical reports while maintaining accurate records and lab notebooks.
- Analyze testing data, input results into the electronic system for certificates of analysis, and prepare reports as necessary.
Method Coordination
- Facilitate method transfers between clients and SGS.
Investigative Participation
- Contribute to investigations regarding out-of-specification (OOS), out-of-trend (OOT), and deviations, executing corrective and preventive actions (CAPA) as required.
Compliance and Maintenance
- Conduct experiments in accordance with company SOPs, deviations, and change control programs, adhering to cGMP guidelines.
- Ensure proper maintenance of equipment, performing necessary calibrations and qualifications.
Client Support
- Provide expert technical assistance to clients and internal teams, representing SGS and its policies during client interactions and regulatory inspections.
Project Participation
- Engage in departmental or company-wide initiatives aimed at enhancing internal efficiency and overall quality of laboratory operations.
Additional Responsibilities
- Perform other laboratory duties as assigned.