Job description
SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.
The Senior Scientist, Analytical Development will act as the subject matter expert and operate in the lab as an independent researcher. You will conceive, implement, and analyze experiments to produce fully independent data. You will be responsible for method development, validation, and transfer of methods used in the testing of biopharmaceutical products or raw materials. You will be responsible for complex decision-making and re-evaluation, optimization, and troubleshooting of methodologies as requested and will lead technical discussions with clients. In addition, this position will provide guidance to and oversee Analysts regarding their performance and will manage small to mid-sized projects to ensure completion 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 Scientist will be held accountable for the team's delivery.
- Execute experiments, following the company’s SOPs, Deviations, and Change Control programs and cGMP guidelines
- Perform development and validation of analytical testing procedures for drug substances, drug products, and raw materials
- Make complex decisions and perform activities relating to the writing of test protocols, method development, and validation of analytical testing procedures
- Participate in and lead investigations for OOS, OOT, and deviations. Participate and execute Corrective Preventative Actions (CAPA)
- Duties 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
- Utilize advanced analytical techniques to identify root causes and determine courses of action
- Provide expert technical support to clients, internal and other SGS groups
- Ensure equipment is adequately maintained; perform calibrations and qualifications as required
- 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 in identifying the cause of failure, and prepare a deviation report and CAPA if it is appropriate
- 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
- Ensure that client requests pertaining to the development and completion of specialized studies are met in a timely and effective manner
- Oversee, train, mentor, and guide Analysts in their work
- Organize and schedule testing with the Group Leader/Department Head
- Represent Company and Company policies as needed during client visits and regulatory agency inspections
- Perform other assigned lab duties as requested
- Bachelor's degree in Chemistry, Biochemistry, Biology, or a related field
- 7+ years of experience performing advanced method development and testing, analysis, and data interpretation in a regulated pharmaceutical or biopharmaceutical lab environment
- Master's degree in Chemistry, Biochemistry, Biology, or a related field
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 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.
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