Resilience Biotechnologies Inc..
RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We’re building a robust, dynamic, and diverse network of manufacturing capability and talent – investing in innovation every step of the way.
We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need. This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines; as well as proteins and the next generation of medicines.
RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small.
We continuously invest in R&D; for next generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives.
We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities. Through manufacturing that’s faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the resilience of a vital supply chain.
The current role requires the application of advanced expertise and techniques to design, develop, and establish scientifically sound bioprocess methods for the development and manufacturing of biopharmaceutical products. The position supports technology transfer, process set-up and operation, non-GMP and GMP document creation and technical training. It also provides technical support, training, and troubleshooting to Drug Development and Manufacturing operations including but not limited to mammalian and insect cell cultures, seed trains, bioreactor operation, metabolite analysis, process optimization, as well as documentation and reporting of results.
· Promote innovative and rigorous thinking in execution of research tasks
· Participate in technology and technical transfer activities of client and internal processes
· Accountable to meet schedule completion dates or to provide timely feedback when dates cannot be met. Support project staff to accomplish specific task/team objectives within overall schedule.
· Lead project team presentations or demonstrations to clients or management
· Interact with project team members and peers to anticipate and resolve day to day issues. Interact with other divisions, customers and suppliers on routine matters to achieve results
· Prepare technical documentation such as experimental outlines, reports, BPRs and SOPs
· Execute experiments, analyze data and report results.
· Identify, offer, and implement contingency plans to prevent and overcome issues and perform method trouble shooting.
· Identify issues, solve problems and incorporate changes into ongoing development and production
· Design and implement mammalian cell culture and bioreactor processes;
· Develop, operate, optimize and troubleshoot processes with minimum supervision
· Train and mentor other team members when required as well as contribute to general shared lab functions to ensure high quality results and "state of the art" processes
· Document and report work to support preparation of patent applications, manuscripts, presentations and regulatory submissions
· Coordinate/execute factory and site acceptance tests and identify, investigate and resolve deviations from user specifications
· Keep abreast of relevant technology development and contribute to the implementation of new platform technologies and instrumentation that improve the quality and throughput of upstream processes
· Follow cGMP quality systems where required and Support execution of IQ, OQ and PQ protocols
· Routine maintenance of cell lines and research cell banks, Master cell banks and working cell banks
· Performs any other related duties as assigned
· Ph.D. or M.Sc. degree in a Bioprocess/Biochemical Engineering, Microbiology, Cell Biology or related fields
· M.Sc. with >5 years or Ph.D. with >3 years of recent scientific and preferably industrial experience in a high technology environment
· Thorough knowledge of bioreactor operation and theory
· Work well independently and in a team environment
· Excellent written and verbal communication skills
· Upstream Processing and experience with mammalian and insect cell culture
· Knowledge of analytical testing including but not limited to ELISA, SDS PAGE, HPLC
· Aseptic techniques knowledge and cGMP experience
· Operational knowledge of various bioreactors, including Single-Use systems
· Knowledge of scale-up strategies and equipment requirements
· Data analysis (cGMP and R&D;) and report preparation with knowledge of MS Word, Excel, PowerPoint and Outlook
· Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
· A detailed knowledge of the scientific method and its application to establish procedures in a logical progression
· Experience with design of experiments (DOE)
· Pre-employment medical and medical re-examination performed every 2 years will be required as per Therapure’s SOPs. Included as part of the medical is a respirator fit test (half mask), and pulmonary function test
· This position requires vaccination for Hepatitis A and B
While we appreciate your interest in this opportunity, only qualified candidates will be contacted. Resilience Biotechnologies Inc. (RESILIENCE), will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to directly Resilience Biotechnologies Inc. (RESILIENCE), or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Resilience Biotechnologies Inc. (RESILIENCE), Human Resources team.
NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted).
Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.
Job Types: Full-time, Permanent
- Dental care
- Employee assistance program
- Extended health care
- RRSP match
- Wellness program
- 8 hour shift
- Post-Doctorate (preferred)
- mammalian and insect cell culture: 3 years (preferred)
- Analytical testing in ELISA, SDS PAGE, HPLC: 3 years (preferred)
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