Principal Scientist, Biologics

SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services.

Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.

• 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.

• Bachelors, Masters/MBA or Doctorate degree in Biochemistry, Chemistry, Biology, or PhD in Mass Spectrometry 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

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 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.