Job Description

The Scientist, Biologics (Biophysical Characterization) will act as a subject matter expert in higher-order-structure (HOS) and biophysical characterization of protein and peptides and operate in the lab as an independent researcher. Knowledge and experience in the analysis of primary, secondary, tertiary protein/peptide structure using amino acid analysis (AAA), N-terminal sequencing, circular dichroism (CD), FTIR, and/or DSC and analysis of protein quaternary structure and aggregates using SEC-MALS, svAUC, and/or DLS is highly desired. **** In this position, you will conceive, implement, analyze experiments to produce fully independent data. Furthermore, you will be responsible for participating in method development, validation, and transfer of methods used in the testing of biopharmaceutical products or raw materials. This position will require interaction with clients and involve presenting data in meetings in clear and concise manner. In addition, this position will involve managing lower-level analysts in their daily activities to ensure completion of small- to mid-size projects in a timely manner to the satisfaction of both SGS and the client.

• Perform evaluation of sophisticated analytical equipment or software, providing expert opinion on quality and feasibility with respect to their use in the Laboratory
• Perform the development and validation of analytical testing procedures for drug substances and drug products
• Write protocols, drafts methods, and technical reports
• Keep all records and lab notebooks in good order. Analyze testing data, enter the testing results into the company’s electronic system for a certificate of analysis and prepare reports, if required, in a timely manner
• Guide Analysts in their work
• Coordinate method transfers between clients and SGS
• Participate in investigations for OOS, OOT, and deviations. Participate and execute CAPA
• Executes experiments, following the company’s SOPs, Deviations, and Change Control programs and cGMP guidelines
• Ensure that equipment is maintained properly; perform calibrations and qualifications as required
• Provide expert technical support to clients, internal and other SGS groups
• Represent Company and Company policies as needed during client visits and regulatory agency inspections
• Ensure that client requests pertaining to the development and completion of specialized studies are met in a timely and effective manner
• Participate in departmental or company-wide projects designed to improve the internal efficiency and overall quality of work performed at the laboratory
• Perform other assigned lab duties as requested.

Qualifications

• Bachelors degree in Biochemistry, Chemistry, Biology, or equivalent.
• 10+ years of experience respectively with demonstrated ability to complete more complex role/duties OR equivalent combination of education and experience (Required)
• Masters degree in Biochemistry, Chemistry, Biology, or equivalent.
• 5+years of experience respectively with demonstrated ability to complete more complex role/duties OR equivalent combination of education and experience
• MBA or Doctorate degree in Biochemistry, Chemistry, Biology, or equivalent.

Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons 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.

o perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability

All your information will be kept confidential according to EEO guidelines.