Senior Research Associate I (Chemical Engineer)

Senior Research Associate I (Chemical Engineer)

Gilead Sciences in Edmonton, Alberta, Canada is seeking a knowledgeable and motivated professional capable of working effectively in a multi-disciplinary team environment. The successful candidate will assume a full-time employment role in the capacity of Senior Research Associate I, Process Development in Gilead Alberta’s Manufacturing Science and Technology (MSAT) department.

Combining laboratory experimentation with engineering calculations and modeling, the successful candidate supports 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.

Essential Duties and Job Functions:

• Demonstrates technical proficiency, scientific creativity, and collaboration skills in the research and development of API manufacturing processes.
• Acts as a process engineering subject matter expert for cross-functional teams and collaborates across functional areas including: process development, analytical operations, quality assurance, engineering and manufacturing to accomplish project goals.
• Applies chemical engineering knowledge to provide solutions to issues that are encountered during process development and manufacturing of clinical and commercial API.
• Completes equipment equivalency and equipment selection evaluations to guide process technology transfer to internal and external manufacturing sites.
• Follows established process engineering workflows and procedures to support process development, scale-up, and scale-down of unit operations.
• Effectively presents and discusses results, and draws conclusions independently. Provides regular updates (written and verbal) and proposes future research directions.
• Prepares clear and concise written work summaries, data analyses, and technical reports.
• Applies engineering modeling and simulations to support process development of manufacturing processes and enabling manufacturing technologies.
• Provides technical support for manufacturing processes performed under cGMP in laboratory manufacturing and large-scale manufacturing operations.
• Ensures that all experimentation is carried out in accordance with appropriate standard operating procedures (SOPs), maintaining quality, safety, and environmental standards.

Knowledge, Experience and Skills:

• 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.
• Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
• In-depth understanding of chemical engineering fundamentals.
• Experience in scale-up and scale-down of chemical process unit operations.
• Familiarity with statistical analysis to evaluate correlations, shifts and trends of chemical processes, and experience of Design of Experiments (DOE) is an asset.
• Familiarity with purification and analytical techniques, including HPLC, LCMS and NMR is an asset.
• Experience with kinetic studies or process analytical technologies (PAT) is an asset.
• Experience with continuous manufacturing is an asset.
• Experience with SAS-JMP, DynoChem, CFD simulation or other statistical analysis or simulation software is an asset.
• Familiarity with process validation and cGMP guidelines is an asset.

Minimum Qualifications:

• MSc in chemical engineering OR
• BSc in chemical engineering or chemistry with chemical engineering training, and 2+ years of relevant pharmaceutical experience.