Principal Scientist, Biologics

SGS•Lincolnshire, IL

2d•$73,000 - $114,000

About The Position

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.

Requirements

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

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.
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.