SGS North America
Biologics Analyst 2
At a glance
Location: US-IL-Lincolnshire Map
Posted: 11/30/2019
Closing: 12/29/2019
Degree: Not Specified
Type: Full-Time
Experience: Not Specified
SGS North America
Job description
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 90,000 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.

Life Sciences Services (LSS) from SGS – optimize your development timelines to get medicines and medical devices to market quickly and safely. As a result, we are often a preferred partner for the top 20 pharmaceutical and biotechnology companies.

Job Summary:


The Analyst 2 is expected to be thoroughly knowledgeable in and will be responsible for all of the routine and complex analytical testing and analyses of biopharmaceutical finished products or raw materials. They will also be able to take on a more diverse mix of testing assignments and will be expected to play a lead role in more advanced or demanding analytical studies. The Analyst 2 may be asked to participate in the preparation and review process of key department documents such as SOPs, forms, worksheets and study protocols. Training of incoming analytical staff, and general laboratory duties pertaining to equipment maintenance and calibration, for instance, may also be applicable to this position. Overall, the Analyst 2 position presents the employee with an opportunity to contribute to the company’s success through both technical knowledge and expertise as well as quality customer service.



Primary Responsibilities



• Ensure that all client requests for information pertaining to analytical testing (or any SGS other services) are met in a timely and effective manner.

• Ensure that routine testing submitted by client is completed within established parameters governing turnaround time, and quality expectations.

• Ensure that client requests pertaining to the development and completion of specialized studies are met in a timely and effective manner. May act as staff liaison for certain specialized testing elements performed routinely for selected clients.

• Participation in departmental and/or company-wide projects designed to improve the nature of SGS client services.

• Ensure that all reasonable client requests pertaining to the conduct of a given test are met in a timely and ultimately effective manner.
SERVICE RESPONSIBILITIES TO INTERNAL CUSTOMERS


• Work as a team with other Analysts and communicate effectively with peers and superiors.

• Report and Assist in the failure investigations as instructed.

• With limited supervision, prepare study protocols, study reports, forms and SOP’s.

• Is comfortable leading and/or participating in technical conversations with SGS clients. Inform the Department Manager and/or Group Leader/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.

• Perform additional assigned lab duties and periodically update Department Manager and/or Group Leader/Scientific Leader on the status.

• Keep the work area clean and organized; immediately clean up spills, dispose of waste according to laboratory procedures and place used glassware in designated locations for cleaning.

• Maintain clean and organized workbench area ensuring spills are immediately cleaned; disposal is according to laboratory procedures, glassware is appropriately handled and lab solutions are replaced.

• Assist in the resolution of routine, as well as non-routine technical problems.

• Ability to step in when the Group/Scientific Leader is not available to be able to answer technical queries as well as help fellow Analysts.

• Assist the Department Manager/Scientific Leader to manage large projects and programs.

• Trouble shooting instrument malfunction or method execution problems; assist the junior analyst with the difficulties in testing.

• Possess the ability to make procedural and technical recommendations for improvement with a firm understanding of the regulatory framework.

• Contact Department Manager and/or Group/Scientific Leader if there are any doubts regarding incumbent’s ability to fulfill test requirements satisfactorily.

• Based on sound knowledge of methods/procedures/policies conduct trouble shooting and investigations to the point of presenting cause identification and solution to Department Manager and/or Scientific Leader.

• Attend training sessions and inform the Department Manager and/or Group Leader/Scientific Leader if there is any doubt regarding the ability to fulfill testing requirements satisfactorily.

• Show initiative in completing work orders and providing solutions for effective lab performance.





TECHNICAL RESPONSIBILITIES



• Execute and perform testing as per methods, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines.

• 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.

• Strictly follows the latest approved version of methods, SOPs, QA manuals unless authorized by Department Manager and/or Group/Scientific Leader in writing.

• Prepare and standardize Test solutions, Standard solutions and Volumetric solutions.

• Ensure that equipment are maintained in good order, perform calibrations and qualifications as required.

• Perform routine and more complex analysis/testing of pharmaceutical and biopharmaceutical finished products and raw materials.

• Ability to execute method verifications, validations, transfers based on signed protocols with little supervision.

• Record data in timely manner.

• Has a high technical aptitude with an understanding of the techniques and procedures employed as well as a background understanding of the analyte of interest.

• Capable of multi-tasking with great accuracy and efficiency

• Be capable to execute new, and/or complicated method development with minimal guidance.

• 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.

• 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.

• Record findings in standardized format, keeping all records and analyst notebook in good order.



ADMINISTRATIVE RESPONSIBILITIES



• Adherence to relevant SGS SOPs governing documentation and reporting.

• Adherence to applicable SGS personnel policies regarding time clock, telephones, sick days, vacation days, etc.

• Compliance with applicable SGS SOPs related to the handling of client complaints.

• Participation in general staff training sessions as these are scheduled.

• Participate in training sessions in the proposal, investigation and introduction of new technologies and services for SGS

• Ensures full compliance with the company’s Health & Safety, Code of Integrity, and Professional Conduct policies.




Job requirements


Education, Required Skills & Competencies:
  • B.S. Chemistry, Biochemistry or equivalent.
  • Over 3 years of analytical laboratory experience with demonstrated ability to complete more complex role/duties with demonstrated ability to complete more complex duties.
  • Demonstrated understanding of protein biochemistry, cell biology, molecular biology, and/or biophysics.
  • Hand/Eye coordination, ability to stand out, think outside the box
  • Micropipette usage (single/multi/repeater)
  • Visual Acuity to conduct visual inspection for colour, clarity, opalescence, and particulates.
  • Able to read, understand and follow work instructions in a safe, accurate and timely manner.
  • Proficient in using various types of computer software (Word, Excel. PowerPoint & Outlook).
  • Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
  • Demonstrates excellent verbal and written communication skills.
  • Ability to work well with others & independently.
  • Proven time management skills and a strong attention to detail.
  • Works well under pressure.
  • Demonstrated basic understanding of protein biochemistry, cell biology, molecular biology, and/or biophysics.
Technical competency in two or more of the following is preferred:

• HPLC, UPLC, and general chromatography experience.
• Ion exchange, size exclusion, reversed phase, hydrophobic interaction.
• Capillary Isoelectric Focusing, and 2D-Gel Electrophoresis
• SDS-PAGE, Native PAGE, cSDS, Western Blot
• ELISA
• Enzyme assay
• DNA isolation, restriction enzyme digestion, PCR, qPCR
• Cell culture, Cell based bioassay
• Protein expression and purification.
• Structure and Function Biochemistry



Additional Information:

• Safety is a top priority within SGS. Every employee within the organization has defined HSE Duties and Responsibilities to ensure that the organization meets its objectives of no harm to personnel, damage to equipment, or harm to the environment.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability 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.
• SGS is an Equal Opportunity Employer.




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Biologics Analyst 2