SGS · 1 day ago
Principal Scientist, Biologics
SGS is the global leader and innovator in inspection, verification, testing and certification services. The Principal Scientist in Biologics will execute and perform testing as per methods, ensuring adherence to Standard Operating Procedures and cGMP guidelines, while also engaging in method verifications and validations.
Responsibilities
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 here 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
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 standardized format, keeping all records and analyst note book in good order
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 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 work flow to assure completion of scheduled tasks and to meet established due dates
Report and Assist in the failure investigations as instructed
Ensure that equipment are maintained in good order; perform calibrations and qualifications as required
With supervision, prepare study protocols, study reports, forms and SOP’s
Constantly look for ways to improve analytical techniques, documentation and daily work duties
Conduct trouble shooting where testing/analytical failures occur in liaison with Group/Scientific Leader and designate
Inform the Department Manager and/or Group/Scientific Leader, as far in advance as possible, if the assigned work order cannot be satisfactorily completed within established scheduled time and quality of work expectations
Qualification
Required
Bachelors, Masters/MBA or Doctorate degree in Biochemistry, Chemistry, Biology, or equivalent
Minimum 5-10 years of experience respectively with demonstrated ability to complete more complex role/duties OR equivalent combination of education and experience
Must have experience working with MS, LC-MS, LC-MS/MS, MALDI-TOF, N-term sequencing and other Mass Spec related projects
Knowledgeable in all regulatory guides impacting their specialized field, such as ICH, FDA, TPP, pharmacopeias
Must possess very strong communication skills allowing them to navigate sensitive and often complex matters with both clients and SGS staff
Company
SGS
SGS is the inspection, verification, testing and certification company.
H1B Sponsorship
SGS has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (9)
2023 (13)
2022 (15)
2021 (18)
2020 (19)
Funding
Current Stage
Public CompanyTotal Funding
unknown2023-04-12IPO
Recent News
2026-01-07
2026-01-06
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