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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, functioning independently within the laboratory environment.

Key Responsibilities:

• Conduct evaluations of advanced analytical instruments or software, offering expert insights on their quality and applicability within the laboratory.
• Develop and validate analytical testing methodologies for both drug substances and drug products.
• Prepare protocols, draft methodologies, and compile technical documentation.
• Maintain accurate records and laboratory notebooks. Analyze testing data, input results into the company's electronic systems for certificates of analysis, and prepare reports as necessary.
• Provide guidance to 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, as well as participate in corrective and preventive actions (CAPA).
• Execute 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.
• Deliver expert technical support to clients and collaborate with internal SGS 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.
• Undertake additional laboratory duties as assigned.

Qualifications:

• Bachelor's degree in Biochemistry, Chemistry, Biology, or a related field.
• A minimum of 10 years of relevant experience, demonstrating the ability to manage complex responsibilities, or an equivalent combination of education and experience.
• Master's degree in Biochemistry, Chemistry, Biology, or a related field.
• A minimum of 5 years of relevant experience, showcasing the ability to handle more intricate roles, or an equivalent combination of education and experience.
• MBA or Doctorate degree in Biochemistry, Chemistry, Biology, or a related field.

Additional Information:

SGS is committed to equal opportunity employment and actively recruits, hires, trains, and promotes individuals in all job classifications without discrimination based on race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, veteran status, or any other characteristics protected by law.

To succeed in this role, candidates must be able to perform each essential duty satisfactorily, with or without reasonable accommodations. The qualifications listed above represent the knowledge, skills, and abilities required for this position.

This job description is intended to provide a general overview of the role 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 necessary.