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The Biologics Scientist specializing in Biophysical Characterization will serve as a key authority in the assessment of higher-order structure (HOS) and biophysical analysis of proteins and peptides, functioning as an autonomous researcher within the laboratory environment.

Key Responsibilities:

• Conduct evaluations of advanced analytical instruments or software, offering expert insights on their quality and applicability in laboratory settings.
• Develop and validate analytical testing methodologies for both drug substances and drug products.
• Draft protocols, methods, and technical documentation.
• Maintain meticulous records and laboratory notebooks. Analyze testing data, input results into the company's electronic systems 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 related to out-of-specification (OOS), out-of-trend (OOT), and deviations, and participate in corrective and preventive actions (CAPA).
• Execute experiments in accordance with company 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 the company 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 work.
• Perform additional laboratory duties as assigned.

Qualifications:

• Bachelor's degree in Biochemistry, Chemistry, Biology, or a related field.
• 10+ years of relevant experience with a proven ability to undertake complex roles and responsibilities, or an equivalent combination of education and experience.
• Master's degree in Biochemistry, Chemistry, Biology, or a related field.
• 5+ years of relevant experience with a demonstrated ability to handle more complex roles and responsibilities, 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, recruiting, hiring, training, and promoting individuals in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To successfully perform this role, individuals must be able to fulfill each essential duty satisfactorily, with or without reasonable accommodations. The requirements outlined above represent the knowledge, skills, and abilities necessary for this position.

This job description is intended to provide a general overview of the position and should not be construed as an exhaustive list of duties, responsibilities, or requirements. The company reserves the right to assign or reassign duties and responsibilities as needed.