SGS_USA_EN_LSS_Biologics Scientist at SGS North America Inc.

Posted in Other 25 days ago.

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Location: Lincolnshire, Illinois





Job Description:
The scientist position is responsible for method development, validation and transfer of methods used in testing of biopharmaceutical products or raw materials. Responsible for complex decision making and re-evaluation, optimisation and troubleshooting of methodologies as required by clients. Responsible for providing guidance to and overseeing analysts within the Analytical Operations regarding the performance of their activities related to department. Responsible for leading technical discussions with clients and managing small to mid-sized projects to ensure completion in a timely manner to the satisfaction of both SGS and client management. Overall, the Scientist role presents the employee with an opportunity to contribute in many ways to the long-term success of both the Biologics Services Laboratory and the company as a whole.

Follow Training SOP for training and training records.

REPORTING LINE

An employee working as Scientist at SGS reports to the Department Manager and/or Scientific Leader

SPECIFIC RESPONSIBILITIES

OUR PROMISE TO OUR CUSTOMERS

At all times, comply with SGS Code of Integrity and Professional Conduct, and to conduct all our testing to to the highest level of cGMP compliance.

SERVICE RESPONSIBILITIES TO CUSTOMERS

• Ensure that all reasonable client requests pertaining to the conduct of a given test are met in a timely and ultimately effective manner.
• Ensure that all client requests for information pertaining to analytical testing (or any of SGS other services) are met in a timely and effective manner.
• Ensure that routine testing submitted by clients is completed within established parameters governing turnaround time, quality specifications, etc.
• 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-wise projects designed to improve the nature of SGS client services.

SERVICE RESPONSIBILITIES TO INTERNAL CUSTOMERS

• Provide technical support and feedback to clients and other SGS groups.
• Liaise with clients to establish project timelines and with SGS management to assess resource requirements.
• Coordinate method transfers between clients, the Research and Development group, and the RM/Finished Products departments
• Assist in the failure investigations within other SGS groups and design investigation protocols and suggest corrective actions.
• Oversee, train, mentor and guide Analysts/Scientists in their work
• Participate in departmental or company-wide projects designed to improve the internal efficiency and overall quality of work performed at the laboratory.
• Act as a specialised technical resource to the team members around potential courses of action to resolve complex problems.
• Knowledgeable in all regulatory guides impacting their specialized field, such as ICH, FDA, TPP, pharmacopeias.
• Perform evaluation of sophisticated analytical equipment or software, providing expert opinion on quality and feasibility with respect to their use in the Laboratory
• Organizes and schedules the testing with the Scientific Leader/Department Head.
• Feedback to Scientific Leader/Department Head and client to support the decision making on any technical and procedure issues

TECHNICAL RESPONSIBILITIES

• Perform the development and validation of analytical testing procedures for drug substances and drug products
• Write protocols, drafts methods and technical reports.
• Ensure that equipment is maintained properly. Also perform calibrations and qualifications as required.
• Executes experiments, 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, adequacy of testing documentation, proper application of test procedures, proper techniques for data capture and recording and preparation of the final report of analysis.
• Write and Review technical data, documents, SOPs and proposals as required.
• In case of a testing failure, immediately report to the Department Head or the designee before proceeding further with the test, lead/assist failure investigations to identify the cause of failure and prepare a deviation report and/or Corrective Preventative Actions (CAPA) if it is appropriate.
• Ensure that work order documentation is complete in every respect and all results are entered into the Electronic Laboratory Information System or client's Certificate of Analysis before submission to the QA reviewer.
• 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.
• Perform other assigned lab duties as requested.
• Utilizes advanced analytical techniques to identify root causes and determine courses of action
• Inform the Department Head if the assigned work order cannot be satisfactorily completed within established scheduled time and quality-of-work expectations.

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

PROFILE

• Education: BSc or MSc/PhD in Biochemistry, Chemistry, Biology (or equivalent experience or training)
• Experience: 5+ years with demonstrated ability to complete more complex role/duties

REQUIRED SKILLS

Specific technical skills:
• Hand/Eye coordination, ability to stand out, think outside the box.
• Able to read, understand and follow work instructions in a safe, accurate and timely manner.
• Must be 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.
• Extended hours and shift work may be required from time to time.
• Travel to other SGS locations or client location may be required from time to time or lead a group of individuals at Client's site.
• Ensures full compliance with the company's Health & Safety, Code of Integrity, and Professional Conduct policies.

OTHER 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.



Qualifications:

• Degree in molecular biology, biochemistry, immunology or related field with broad bioanalytical background
• Must have BA, MS, or PhD with minimum of 4 years of or equivalent professional experience, preferably obtained in a laboratory or research and development setting.
• Previous Study Director and/or supervisory experience in a GLP/GMP/GCP environment.
• Experience working with biological samples such as plasma and serum.
• Previous immunochemistry laboratory experience
• Must have expertise in two or more of the following platforms: ELISA, MSD, Luminex multiplex assays, RIA)
• Prior supervisory or lead experience required.
• Flexible to accept new duties, assignments and responsibilities and should be willing to conduct tasks which eventually will be performed by different level employees.
• Solid grasp of intermediate to advanced scientific language required.
• Critical thinking skills appropriate for advanced problem-solving activities required.
• Must have intellectual aptitude for analyzing data and drawing conclusions based on current guidelines, practices, and SOPs.
• Computer proficiency preferred.
• Must produce adequate documentation of all testing according to SGS Standard Operating Procedures.
• Must provide thorough and complete review of test documentation.
• Commitment to quality

ADDITIONAL INFORMATION:

• 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, 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 EOE AA M/F/Vet/Disability employer.

Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, protected veteran status or disability.

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 be called back shortly. 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.