Division: Downstream platform of the Bioprocess R&D (BRD) department.
Reporting to : Platform leader, Downstream Bioprocess R&D
Job Type: 14 month contract - in house, M-F , 9-5
- Development of purification processes for the generation of clinical trials material (proteins and viruses) from microbial and animal cell culture for use as vaccines.
- The scientist will interface between Research, Analytical Research and Development, and Manufacturing Technology.
- Supervise, train, motivate and empower technical personnel to perform the experimental and processing tasks.
- Responsible for specific scientific, technical and compliance aspects of assigned project, ensure that objectives are met.
- Plan and supervise execution of product development activities (develop, improve, scale-up processes, and provide material and documentation for purified proteins or viruses) within platform for the project to ensure scientific and technical excellence.
- Keep abreast of the current developments in relevant scientific and technical disciplines and ensure current developments are implemented when appropriate.
- Prepare internal and external presentations, patent filings, research manuscripts and review articles as required.
- Manage and develop competencies of direct reports.
- Ensure compliance of direct reports with GxP and other quality and documentation requirements, such as preparation of SOPs and BPRs.
- Provide leadership for data input, standardized formats, database creation and management, and implementation of corporate standards.
- Ensure that direct reports are well-informed about current policies, new directions and training initiatives.
- Ensure teamwork and empowerment of all direct reports.
- Coach and motivate staff to perform efficiently and achieve objectives on time, on budget.
- Support regulatory submission by participating in preparation of regulatory submission documents (CTA, IND, CTD).
- In depth knowledge of experimental work and data analysis.
- Development of purification processes for vaccine candidate supply.
- Expertise required includes various chromatography separation, buffer exchange and tangential flow filtration, centrifugation, sonication, protein stabilization during the purification process and chemical treatment as required.
- Use of analytical methods for measuring purity, quality and process yield by assays such as protein content, SDS-PAGE, ELISA, HPLC, LAL et al.
- Development of appropriate in-process testing for the purification process development if needed.
- Support for GMP manufacturing including process technology transfer, equipment selection and validation, process flows, vendor and raw materials selection, and process trouble shootings
- PhD (Biochemistry, Biochemical Engineering, Microbiology, Chemistry) with
- 2+ years' experience, or MSc (Biochemistry, Biochemical Engineering, Microbiology, Chemistry) with 5+ years' experience, in protein purification, or vaccine development or relevant field.
- In-depth knowledge of protein purification, primary recovery processes, process analytical technology and quality by design.
- Working knowledge of microbiology, biochemistry, chemical engineering principles,
- In-depth knowledge of experimental design, execution and data analysis.
- Strong computer, scientific writing and presentations skills.
- Proven supervisory/management/people development experience is required.
- Highly organized and excellent communication, interpersonal and team leadership skills.
- Familiarity with strategic planning and budget process.
ownstream platform of our Bioprocess R&D (BRD) department
Job Types: Full-time, Contract
- vaccine: 3 years (Required)
- Bachelor's Degree (Required)
- North York, Toronto (Preferred)