Biotech Analyst

2 weeks ago


Mississauga, Canada SGS Full time

Company Description

WE ARE SGS - THE WORLD’S LEADING TESTING, INSPECTION AND CERTIFICATION COMPANY. WE ARE RECOGNIZED AS THE GLOBAL BENCHMARK FOR QUALITY AND INTEGRITY. OUR 96,000 EMPLOYEES OPERATE A NETWORK OF 2,600 OFFICES AND LABORATORIES, WORKING TOGETHER TO ENABLE A BETTER, SAFER AND MORE INTERCONNECTED WORLD.

**Job Description**:
This position is responsible for performing analytical testing and analysis of biopharmaceutical drug substance, drug products, and raw materials.
- Execute and perform testing as per methods, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines.
- Work as a team with other Analysts and communicate effectively with peers and superiors.
- Ensure that work order documentation is complete in every aspect and all results are entered into the electronic Laboratory Information System or the Client’s Certificate of Analysis before submission to the QA reviewer.
- Prioritize, schedule and plan daily work in order to maintain efficient workflow to assure completion of scheduled tasks and to meet established due dates.
- Report and Assist in the failure investigations as instructed.
- Ensure that equipment is maintained in good order; perform calibrations and qualifications as required.
- Record findings in standardized format, keeping all records and analyst notebook in good order.
- With supervision, prepare study protocols, study reports, forms and SOP’s.
- Record data in timely manner.
- 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.
- Perform additional assigned lab duties and periodically update Department Manager and/or Group/Scientific Leader on the status.
- Attend training sessions and inform the Department Manager and/or Group/Scientific Leader if there is any doubt regarding the ability to fulfill testing requirements satisfactorily.
- 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.
- Prepare and standardize Test solutions, Standard solutions and Volumetric solutions.
- Assist in the resolution of routine technical problems.
- 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 supervision.
- Strictly follows the latest approved version of methods, SOPs, QA manuals unless authorized by Department Manager and/or Group/Scientific Leader in writing.
- Show initiative in completing work orders and providing solutions for effective lab performance.
- Ensures full compliance with the company’s Health & Safety, Code of Integrity, and Professional Conduct policies.

**Qualifications**:

- Education: B.Sc. Chemistry, Biochemistry or equivalent.
- Experience: over 1 year with demonstrated ability to complete more complex role/duties.
- 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.
- 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 understanding of protein biochemistry, cell biology, molecular biology, and/or biophysics.
- Technical competency in two or more of the following.
- 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



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