Scientist, Biologics

SGSMississauga, ON, CA

Il y a 18 jours

Description de poste

Job Description

The Scientist is responsible for performing analytical testing and analysis of biopharmaceutical drug substance, drug products, and raw materials, as well as assisting other scientists in the completion of their tasks. Operates in the Lab as an independent researcher. Conceives, implements, and analyzes experiment to produce data independently. Supervises 1 (non-HR) or more junior scientists running a team, group, etc. Attends and contributes to Client-facing meetings. Has clear vision to revenue producing activities and is held accountable. A person at the Scientist 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.

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 notebook 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 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.

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.

Qualifications

Bachelors, Masters / MBA or Doctorate degree in Biochemistry, Chemistry, Biology, or equivalent is required.

Minimum 10+ / 5+ / 0 years of experience respectively with demonstrated ability to complete more complex role / duties OR equivalent combination of education and experience is required.