Company Description

SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services.

Job Description

The Manager, Biologics (Biophysical Characterization) will act as the 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 required. In this position, you will conceive, implement, analyze experiments to produce fully independent data. Furthermore, you will be responsible for overseeing method development, validation, and transfer of methods used in the testing of biopharmaceutical products or raw materials. This position will be a primary contact for the client(s) and will lead technical discussion and be responsible for making complex decisions regarding evaluation, optimization, and troubleshooting of methodologies. In addition, this position will involve managing a group of 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. With global visibility and a clear vision for revenue-producing activities, the Principal Scientist will be held accountable for the team's delivery.

• Oversee, train, mentor, and guide Analysts in their work
• 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
• Coordinate method transfers between clients and SGS
• Participate in and lead 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
• Liaise with clients to establish project timelines and with SGS management to assess resource requirements
• 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
• Ensure that client complaints are dealt with effectively according to applicable SGS SOPs
• Ensure that all client requests for analytical testing information or time and materials estimates for quotation purposes (or information regarding any of SGS's other services) are met in a timely and effective manner
• Play a lead role in departmental and/or company-wide projects designed to improve the nature of SGS client services
• Participate in departmental or company-wide projects designed to improve the internal efficiency and overall quality of work performed at the laboratory
• Organizes and schedules the testing with the Group Leader/Department Head
• Feedback to Scientific Leader/Department Head and client to support the decision making on any technical and procedure issues
• Perform other assigned lab duties as requested.

Qualifications

• Ph.D. degree in Chemistry, Biology, or related sciences
• 7+ years experience performing advanced testing, analysis, and data interpretation in a regulated, commercial lab environment OR equivalent combination of education and experience

• 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

• Experience in the analysis of protein quaternary structure and aggregates using SEC-MALS, svAUC, and/or DLS

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.

To 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 callback. 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.