Scientist Ii
1 week ago
Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made.
We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visitPosition Summary & Role
The Scientist II Formulation and Analytical Development is responsible for establishing and maintaining a formulation development and analytical capability to support small molecule liquid Drug Product development including alum-containing, nanoparticle, and lipid-encapsulated small molecules.
Responsibilities are formulation assay and process development, transfer, and qualification support as needed, including formulation component and process design, screening, optimization, related testing, and execution and reporting, working closely with Manufacturing and Quality teams and clients.
The Scientist possesses knowledge of scientific principles and concepts in fields of small molecule, biomolecule, nucleic acid, lipid, and particle characterization, chemical structure/interaction, physicochemistry, and liquid formulation process design for bulk Drug Substance, and Drug Product in vials and syringes.
Experience with formulation process scale-up, qualification, engineering, and in-process/release analytical equipment is also desirable.Job Responsibilities
- Developing and performing smallscale, small molecule liquid formulation screening, optimization, and stability testing and assessing product chemical, solution, and physical properties with a range of study design and analytical tools.
- Performing small molecule and biomolecule analytical characterization, including assay development and testing solution, suspension, aggregate, and particle analyses in support of process and formulation optimization.
- Establishing and overseeing outsourced analytical testing where needed based on a strong knowledge of advanced methodology.
- Performing solubilization, mixing, transfer, filling, sampling, and storage, including UF/DF or dialysis/filtration to assess formulation process performance at small scale.
- Assisting in research, product, and process development for current and novel work.
- Participating in maintaining capabilities, databases, laboratories, equipment, and supplies.
- Writing and reviewing study protocols, SOPs, qualification protocols, reports, and other product development documents.
- Supporting Development, Manufacturing Sciences, Manufacturing and other departments as needed.
- All other tasks as needed or assigned by supervisor.
- Background in small molecule and biomolecule analytical and formulation.
- Strong writing, analysis, and communication skills including both oral and written.
- Ability to connect at all levels of the organization and in a teamwork environment.
- Must be proficient in managing multiple tasks and prioritizing workload with effective independent followup with timely results.
- Able to work in a fastpaced, resultsoriented environment.
- Must have excellent organizational, planning, and attention to detail skills.
- Experience in process development and/or manufacturing, use of software modeling, statistical, and analytical tools.
Additional Requirements:
- Preemployment medical and medical reexamination; inclusive of eye examination and colour blindness test, performed every 2 years or as required
- This position requires vaccination for Hepatitis A and B
- Job requires shift work, weekends and occasional extended shifts and possible short notice schedule shift changes
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential function of this job.
The employee will perform testing using equipment placed on work benches, will need to be able to work at the lab bench for the entire workday, and must be able to use both hands and use all digits.
Adequate eyesight is a must for operation of the equipment. The safety system includes audible alarms. Adequate hearing is therefore a requirement. Must be able to use the required safety equipment such as face masks, respirators and gowning.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.-
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