SGS
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United States
Senior Scientist, Biologics
Toronto
CAD 100,000 – 125,000
Company Description
We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
Job Description
The Senior Scientist, Biologics will operate in the lab as an independent researcher and 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. As the primary contact for clients, this position will lead technical client discussions, make complex decisions, re-evaluate, optimize and troubleshoot methodologies as required by the client. With aid from the Department Head and Group Leader, you will help oversee the performance of the group, resource allocation, and scheduling along with managing small to midsized projects, ensuring completion in a timely manner to the satisfaction of the client and SGS.
- Execute and perform testing as per methods, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines as required by client submissions.
- Duties include preparation for testing by using good time management skills for each assigned task, such as confirming availability of resources (standards, equipment, etc.) and adequacy of testing documentation, proper application of test procedures, proper technique for data capture and recording, and preparation of the final report of analysis.
- Ability to execute method verifications, validations, transfers based on signed protocols with supervision.
- Perform routine and more complex analysis/testing of pharmaceutical and biopharmaceutical finished products and raw materials.
- Record data in a timely manner.
- Strictly follows the latest approved version of methods, SOPs, QA manuals unless authorized by Department Manager and/or Group/Scientific Leader in writing.
- Record findings in a standardized format, keeping all records and analyst notebooks in good order.
- Adheres to internal standards, policies, and procedures.
- Performs other duties as assigned.
- Ensure that all reasonable client requests pertaining to the conduct of a given test are met in a timely and ultimately efficient manner.
- Ensure that all client requests for information pertaining to analytical testing (or any of SGS’s other services) are passed on to appropriate company personnel in a timely and effective manner.
- Ensure that routine testing submitted by clients is completed within established parameters governing turnaround time and quality-of-work expectations.
- Participation in departmental and/or company-wide projects designed to improve the nature of SGS client services.
- Work as a team with other scientists and communicate effectively with peers and superiors.
- Prioritize, schedule, and plan daily work in order to maintain efficient workflow to assure completion of scheduled tasks and to meet established due dates.
- Report and Assist in the failure investigations as instructed.
- Ensure that equipment is maintained in good order; perform calibrations and qualifications as required.
- With supervision, prepare study protocols, study reports, forms, and SOP’s.
- Prepare and standardize Test solutions, Standard solutions, and Volumetric solutions.
- Assist in the resolution of routine technical problems.
Qualifications
- Ph.D. degree in Chemistry, Biology, or related sciences.
- 4-7 years experience performing advanced testing, analysis, and data interpretation in a regulated, commercial lab environment.
- OR Master’s degree in Chemistry, Biology, or related sciences with 10+ years experience performing advanced testing, analysis, and data interpretation in a regulated, commercial lab environment.
- OR B.S. degree in Chemistry, Biology, or related sciences with 15+ years experience performing advanced testing, analysis, and data interpretation in a regulated, commercial lab environment.
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 and Indigenous status, 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
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