Principal Scientist, Biologics

Lincolnshire, IL - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

Execute and perform testing as per methods following the companys 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 SOPs.
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.

Qualifications :

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

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 companys 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 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.

Remote Work :

Employment Type :

Full-time

Execute and perform testing as per methods following the companys 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...

Execute and perform testing as per methods following the companys 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 SOPs.
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.

Qualifications :

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

Additional Information :

Remote Work :

Employment Type :

Full-time

Key Skills

Machine Learning
Python
Data Science
AI
R
Research Experience
Sensors
Drug Discovery
Research & Development
Natural Language Processing
Data Analysis Skills
Toxicology Experience

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About Company

SGS

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 ... View more

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