Job Description

PRIMARY RESPONSIBILITIES

In general, responsible for performing analytical testing and analysis of biopharmaceutical drug substance, drug products, and raw materials, as well as assisting other Analysts in the completion of their tasks.  Specific expertise with HPLC methods as applied to biologics (e.g. therapeutic proteins or antibodies) is highly desired.  General duties essential to an orderly, efficient and prepared Analytical laboratory will also be applicable to this position.  A person at the Analyst level may be asked to participate in the preparation and review process for laboratory SOPs and forms/worksheets.  Overall, this position presents the employee with an opportunity to play a key customer service role in the company while simultaneously learning the technical skills required to advance in the field of pharmaceutical analysis.

Follow Training SOP for training and training records.

REPORTING LINE

Reports to the Department Manager and/or Group 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 CLIENTS

·       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.

SERVICE RESPONSIBILITIES TO INTERNAL CUSTOMERS

·       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.

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

·       Assist in the resolution of routine technical problems.

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

·       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.

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

·       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.

TECHNICAL 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. 

·       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.

·       Record data in timely manner.

·       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.

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.

Qualifications

PROFILE

·       Education: B.S. Biochemistry, Chemistry, Biology, or equivalent.

·       Experience: Min 1 year, preferably in the biopharmaceutical industry, 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.

·       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:

·       Liquid Chromatography

·       Instrumental analysis of biologics

·       cGMP Compendial Testing

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.