Scientist, Process Development

仕事内容

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 Scientist, Process Development, in Gilead Alberta’s Manufacturing Science and Technology (MSAT) department.

This individual will support Gilead’s commercial small-molecule drug substance manufacturing at both internal and external manufacturing facilities. These activities will include chemical process development and optimization, process characterization, risk assessments, scale-down and scale-up studies. In addition, this individual will be responsible for process technology transfer and process validation activities, continued process verification and manufacturing investigations.

Job Responsibilities

• Responsible for developing chemical processes for the manufacturing of drug substances.

• Plans, designs, implements and analyzes laboratory experimentation to advance the knowledge of production and quality attributes of drug substances.

• Advises members of project teams in the initiation and execution of laboratory experimentation, considering various factors.

• In collaboration with senior scientists or scientific directors, advances the development of economical, state-of-the-art techniques to isolate, characterize, purify and mass-produce substances.

• Prepares and reviews technical documents including research reports and process development reports.

• Acts as MSAT SME for one or multiple API projects. Experienced with manufacturing operations and responsible for supporting commercial manufacturing as technical subject matter expert.

• Monitors key manufacturing activities and manufacturing performance and provides regular updates. Proactively communicates issues and identifies improvement opportunities.

• Prepares and reviews manufacturing and transfer documents including contract manuals, batch records, continued process verification and validation protocols and reports.

• Able to support technical transfers and process validation activities at internal and external manufacturing facilities

• Understands both quality and compliance principles associated with cGMP manufacturing

• Able to support investigation of manufacturing deviations, out-of-specifications and complaints

• Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.

• May make contributions to scientific literature and conferences through publication and presentation of research results.

• Demonstrates ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes.

• Demonstrates excellent communication skills (both verbal and technical) and strong interpersonal skills.

• Demonstrates collaborative communication and problem solving spirit

Basic Qualifications

PhD in Organic Chemistry (or related discipline)

OR

MSc in Organic Chemistry with 6+ years of industry experience

OR

BSc in Organic Chemistry with 8+ years of industry experience