Sr Scientist, Process Development

Canada - Alberta - Edmonton Process/Product Development & Operations Regular

Job Description

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 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.

• Develop chemical processes for the manufacturing of drug substances.
• Plan, design, implement, and analyze laboratory experiments to advance knowledge of production and quality attributes of drug substances.
• Advise project teams in the initiation and execution of laboratory experimentation, considering various factors.
• Collaborate with more senior scientists or scientific directors to advance the development of economical, state-of-the-art techniques to isolate, characterize, purify, and mass-produce substances.
• Prepare and review technical documents including research reports and process development reports.
• Act as MSAT lead for one or multiple API projects; support commercial manufacturing as technical subject matter expert.
• Monitor key manufacturing activities and performance; provide regular updates and proactively communicate issues and improvement opportunities.
• Prepare and review manufacturing and transfer documents including contract manuals, batch records, continued process verification and validation protocols and reports.
• Lead technical transfers and process validation activities at internal and external manufacturing facilities.
• Understand and apply quality and compliance principles associated with cGMP manufacturing.
• Support investigations of manufacturing deviations, out-of-specifications and complaints as needed.
• Think critically and creatively; work independently; determine resources for problem resolution; maintain strong organizational and planning skills.
• Contribute to scientific literature and conferences through publication and presentation of research results when applicable.
• Develop methods, techniques, and evaluation criteria for obtaining results and interpreting experimental outcomes.
• Demonstrate excellent verbal and written communication skills and strong interpersonal abilities; foster collaborative problem solving.

• Basic Qualifications
• PhD in Organic Chemistry (or related discipline) with 2+ years of industry experience
• OR MSc in Organic Chemistry with 6+ years of industry experience
• OR BSc in Organic Chemistry with 8+ years of industry experience

• Preferred Qualifications
• Experience planning and executing multi-step synthesis of organic molecules
• Experience scaling up synthetic routes and developing safe chemical processes
• Familiar with commercial scale production of API and intermediates in plant or pilot plant facilities
• Experience with technical transfer, cGMP and statistical process control
• Knowledge of chemical engineering principles is an asset
• Familiarity with purification and analytical techniques required for drug substance manufacturing
• Strong desire to work in multi-disciplinary teams, learn new skills and 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
• Strong organizational and planning skills

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential; ensure employees receive feedback needed to grow and develop.
• Empower Teams - align goals, purpose, and organizational objectives; provide support to remove barriers and connect the team to the broader ecosystem.