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Pharmaceutical Process Development Engineer
2 months ago
Gilead Sciences, Inc. in Edmonton, Alberta, Canada is seeking a highly skilled professional to assume a full-time employment role as Senior Research Associate I, Process Development in the Manufacturing Science and Technology (MSAT) department.
The ideal candidate will combine laboratory experimentation with engineering calculations and modeling to support the manufacturing of active pharmaceutical ingredients (API) by applying chemical engineering fundamentals in process development, characterization, optimization, risk assessments, technology transfer, and scale-up/scale-down models.
Key Responsibilities:- Demonstrate technical expertise, scientific creativity, and collaboration skills in research and development of API manufacturing processes.
- Provide subject matter expertise for cross-functional teams and collaborate across functional areas, including process development, analytical operations, quality assurance, engineering, and manufacturing to accomplish project goals.
- Apply chemical engineering knowledge to resolve issues encountered during process development and manufacturing of clinical and commercial API.
- Evaluate equipment equivalency and select equipment to guide process technology transfer to internal and external manufacturing sites.
- Follow established process engineering workflows and procedures to support process development, scale-up, and scale-down of unit operations.
- Present results effectively and draw independent conclusions, providing regular updates and proposing future research directions.
- Prepare clear and concise written work summaries, data analyses, and technical reports.
- Utilize engineering modeling and simulations to support process development of manufacturing processes and enabling manufacturing technologies.
- Provide technical support for manufacturing processes performed under cGMP in laboratory manufacturing and large-scale manufacturing operations.
- Strong desire to work in multi-disciplinary teams, learn new skills, and proactively solve problems.
- Excellent verbal and written communication skills and strong interpersonal collaboration skills.
- Critical thinking and creative problem-solving abilities, with the capacity to work independently.
- In-depth understanding of chemical engineering fundamentals.
- Experience in scale-up and scale-down of chemical process unit operations.
- Familiarity with statistical analysis, purification techniques, kinetic studies, and process analytical technologies (PAT).
- Experience with SAS-JMP, DynoChem, CFD simulation, or other statistical analysis software.
We offer a competitive salary range of $90,000 - $120,000 per annum, depending on qualifications and experience.
In addition to a generous compensation package, we provide comprehensive benefits, including health insurance, retirement plans, and paid time off.
