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Chromatography Scientist at SGS North America Inc.

Posted in Other 30+ days ago.

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Location: Lincolnshire, Illinois





Job 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 95,000 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.

Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.

Life Sciences Services (LSS) from SGS - optimize your development timelines to get medicines and medical devices to market quickly and safely. As a result, we are often a preferred partner for the top 20 pharmaceutical and biotechnology companies.

Job Summary:
The Senior Scientist position is responsible for method development, validation and transfer of methods used in testing of biopharmaceutical products or raw materials. Responsible for complex decision making and re-evaluation, optimization and troubleshooting of methodologies as required by clients. Responsible for providing guidance to and overseeing analysts within the Analytical Operations regarding the performance of their activities related to department.

Additionally, you'll be leading technical discussions with clients and managing small to mid-sized projects to ensure completion in a timely manner to the satisfaction of both SGS and client management. With aid from the Department head and/or Group Leader, managing performance of group, resource allocation and scheduling.

Overall, the Scientist role presents the employee with an opportunity to contribute in many ways to the long-term success of both the Biologics Services Laboratory and the company as a whole.

Primary Responsibilities

Service Responsibility to Clients:
• Develop, implement, and maintain systems to ensure that SGS clients receive top-notch customer service.
• Ensure that all client requests for analytical testing information or time and materials estimates for quotation purposes (or information regarding any of SGS other services) are met in a timely and effective manner.
• Develop, implement, and maintain systems to ensure that established parameters governing turnaround time and quality expectations are met on a consistent basis in the Analytical Services Laboratory.
• Ensure that client requests pertaining to the development and completion of specialized studies 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.
• Represent Company and Company policies as needed during client visits and regulatory agency inspections.

Service Responsibility to Internal Stakeholders:
• Oversee, train, mentor and guide Analysts in their work.\
• Liaise with clients to establish project timelines and with SGS management to assess resource requirements.
• Coordinate method transfers between clients, the Research and Development group, and the RM/Finished Products departments.
• Perform evaluation of sophisticated analytical equipment or software, providing expert opinion on quality and feasibility with respect to their use in the Laboratory.
• Utilizes advanced analytical techniques to identify root causes and determine courses of action.
• Participate in departmental or company-wide projects designed to improve the internal efficiency and overall quality of work performed at the laboratory.
• Act as a specialized technical resource to the team members around potential courses of action to resolve complex problems.
• Knowledgeable in all regulatory guides impacting their specialized field, such as ICH, FDA, TPP, pharmacopeias.

Technical Responsibilities:
• Perform the development and validation of analytical testing procedures for drug substances and drug products.
• Write protocols, drafts methods and technical reports.
• Write and Review technical data, documents, SOPs and proposals as required.
• Make complex decisions and perform activities relating to method development and validation of analytical testing procedures.
• Ensure that equipment is maintained properly. Also perform calibrations and qualifications as required. Participate in and lead investigations for OOS, OOT, and deviations. Participate and execute CAPA.
• Executes experiments, following the company's Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines.
• Duties here include preparation for testing by using good time management skills for each assigned task, adequacy of testing documentation, proper application of test procedures, proper techniques for data capture and recording and preparation of the final report of analysis.
• In case of a testing failure, immediately report to the Department Head or the designee before proceeding further with the test, lead/assist failure investigations Preventative Actions (CAPA) if it is appropriate.
• Ensure that work order documentation is complete in every respect and all results are entered into the Electronic Laboratory Information System or client's Certificate of Analysis before submission to the QA reviewer.



Qualifications:

Education, Required Skills & Competencies:
• B.S., M.S or PhD in Biochemistry, Chemistry, Biology (or equivalent in experience and training).
• 2-5 years' relevant previous laboratory experience in a regulated industry with demonstrated ability to complete more complex role/duties.
• Demonstrated understanding of cGMP/GLP.
• Must be proficient in using various types of computer software (Word, Excel. PowerPoint & Outlook).
• Travel to other SGS locations or client location may be required from time to time or lead a group of individuals at Client's site.
• Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
• Capable of interacting with all levels of management, suppliers and clients

Additional Information:
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, skill, and/or ability 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.

SGS is an EOE AA M/F/Vet/Disability employer.

Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, protected veteran status or disability.

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 be called back shortly. 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.