Process Scientists, Technical Operations Biologics

2 weeks ago

Windsor, Canada BioVectra Inc. Full time

BIOVECTRA Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents.

**BIOVECTRA Inc.** has openings for
** Process Scientists, Technical Operations, Biologics. **These are permanent, full-time positions located in
**Windsor, NS.**
- Monitoring bioprocess steps in the production of pilot scale biopharmaceutical products.
- Monitoring the work according to required SOPs for engineering runs (documentation, developing sample plans, labeling, equipment use and cleaning).
- Taking ownership over the process transfer, facility fit experiments, and scale up parameters.
- Preparation and presentation of process data internally and externally.
- Establishing a thorough understanding of lab and available process information to enable the writing and or review of pilot scale Batch Production Records.
- Taking ownership for the pilot scale BPRs by ensuring the data collected supports process transfer plan.
- Supporting the development of BPRs for new processes and changes to existing processes.
- Creating the initial statistical process control file.
- Writing technology transfer risk assessments, tech transfer protocols and summary reports for internal and external use.
- Analyzing and reviewing process data, reports for scale-up, process control, annual reviews, and investigations.
- Performing field tests in the pilot or production environment as required to minimize process scale up risk.
- Interacting with process readiness teams for new processes as well as process modifications.
- Working within the quality system, assisting in the resolution of CSIR or non-conformance issues with respect to production.
- Maintaining proficiency in the operation of all relevant pieces of process equipment.
- Create and collaborate on process specific training.
- Adhering to BIOVECTRAs Health and Safety Policy as outlined in CP0010 Occupational Health and Safety Policy, Statements of Principle, and Responsibilities.
- Additional duties assigned, based on business needs and the department supervisor’s request.
- Bachelor of Science, Chemistry or Engineering preferred.
- Master of Science in Engineering, Biotechnology, Chemistry or similar an asset.
- Three years of industrial experience.
- Knowledge of analytical methodology.
- Computer word processing and spreadsheet software.

**BIOVECTRA offers a competitive salary and benefit package.

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