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The Scientist, Biologics specializing in Biophysical Characterization will serve as a leading authority in the assessment of higher-order structures (HOS) and biophysical analysis of proteins and peptides, conducting independent research within the laboratory environment.

Key Responsibilities:

• Evaluate advanced analytical instruments or software, offering expert insights on their quality and applicability within the laboratory.
• Develop and validate analytical testing protocols for both drug substances and drug products.
• Draft protocols, methodologies, and technical documentation.
• Maintain meticulous records and laboratory notebooks. Analyze testing data, input results into the company’s electronic system for certificates of analysis, and prepare reports as necessary.
• Guide and mentor junior analysts in their daily tasks.
• Facilitate method transfers between clients and SGS.
• Engage in investigations for out-of-specification (OOS), out-of-trend (OOT), and deviations, executing corrective and preventive actions (CAPA).
• Conduct experiments in accordance with the company’s standard operating procedures (SOPs), deviations, and change control protocols, adhering to current Good Manufacturing Practices (cGMP).
• Ensure proper maintenance of equipment; perform necessary calibrations and qualifications.
• Provide expert technical support to clients and internal teams.
• Represent SGS and its policies during client visits and regulatory inspections.
• Ensure timely and effective responses to client requests regarding specialized studies.
• Participate in departmental or company-wide initiatives aimed at enhancing internal efficiency and overall quality of laboratory operations.
• Perform additional laboratory duties as assigned.

Qualifications:

• Bachelor’s degree in Biochemistry, Chemistry, Biology, or a related field.
• 10+ years of relevant experience demonstrating the ability to manage complex roles or an equivalent combination of education and experience.
• Master’s degree in Biochemistry, Chemistry, Biology, or a related field.
• 5+ years of relevant experience demonstrating the ability to manage complex roles or an equivalent combination of education and experience.
• MBA or Doctorate in Biochemistry, Chemistry, Biology, or a related field.

Additional Information:

SGS is committed to equal opportunity employment and does not discriminate based on race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, veteran status, or any other characteristic protected by law.

To successfully perform this role, individuals must be able to fulfill each essential duty satisfactorily, with or without reasonable accommodations. The qualifications listed above represent the knowledge, skills, and abilities required.

This job description is intended to provide a general overview of the position and does not encompass all duties, responsibilities, or requirements. The company reserves the right to assign or reassign duties and responsibilities as necessary.