Analyst II - Analytical and Quality Control

Job Overview

Job #: 3022901

Title:

Analyst II, Analytical and Quality Control

Client:
Biotechnology company

Contract/Perm & duration: 9-month contract (possibility of extension/conversion)

Location:

Toronto, Onsite Monday-Friday

Pay Rate: $28-33/hr (T4)

Description of Position:
The Toronto, ON site is seeking an Analyst 2 to join our Analytical Development (AD) team, a pillar of the greater Analytical and Quality Control (AQC) function that is responsible for the introduction, development, and life cycle management of novel assays and analytical technologies within AQC. As a central development resource at the company, the AQC team works closely with research, process development, non-clinical and clinical development, manufacturing and quality teams.

The successful candidate will be a key scientific contributor and technical leader as part of the larger Technical Operations organization in a dynamic and progressive team developing industry‑leading cell‑based analytics to characterize cell therapy products and manufacturing processes.

• Design and execute in vitro experiments to assess, develop and optimize novel molecular and cell‑based functional to characterize cell therapy products and raw materials
• Develop analytical testing solutions in support of raw material characterization and understanding, release, and stability
• Develop analytical tests for PAT, in‑process testing and controls, as well as release of drug products and process intermediates
• Ensure that assays meet requirements for the intended use of the assays, which includes characterization, lot release, stability and comparability testing of development and manufacturing batches and establish phase‑appropriate specifications
• Analyze experimental data to draw conclusions that support decision making and next steps within and across projects
• Perform other biochemical, cellular, and/or molecular assays as required
• Qualify assays as appropriate and provide training and further qualification/validation support as needed
• Prepare and present project plans and regular project progress updates and recommendations
• Document experimental data in electronic laboratory notebooks in a timely and accurate manner in accordance with the company quality management system
• Prepare, review, and approve experimental protocols, reports, standard operating procedures and other scientific and quality documents
• Requires hands‑on laboratory work in addition to training and supervision of junior staff members in supporting analytical activities within the AQC team
• Present scientific data to colleagues in group meetings, prepare and present internal and external presentations as required
• Contribute to building a culture that embraces scientific excellence, integrity, urgency, courage and community

• Advanced (BSc or MSc) degree in biological sciences, or similar with 2+ (BSc) or 0+ (MSc) years of relevant experience, preferably in an industry environment
• Hands‑on experience in developing, optimizing and qualifying chemical and biochemical assays for small molecules and proteins (HPLC, ELISA, BLI, SPR, FTIR, electrophoresis, etc) according to industry and best practice standards is preferred and required
• Hands‑on experience in mammalian cell culture and cell characterization experience is preferred
• Practical knowledge of statistical analysis of data is required
• Knowledge and understanding of statistical programming languages (R, python, etc.) and Design of Experiments (DoEs) is an asset
• Proven ability to structure, plan, and execute experiments and independently execute complex tasks in a fast‑paced environment
• Excellent organizational and problem‑solving skills, with demonstrated ability to work cross‑functionally
• Proficiency in technical scientific writing
• Excellent interpersonal, verbal and written communication skills
• Experience with GxP guidelines/documentation and general GxP experience in analytical development is an asset but not required

• Candidate will be working in office and controlled laboratory environments
• Risk of potential exposure to chemicals and biohazards consistent with somatic cell therapy culture