Principal Scientist, Process Development

Gilead Sciences • Edmonton, AB

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About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Principal Scientist, Process Development at Gilead you will ... Be responsible for developing chemical processes for the manufacturing of drug substances Demonstrate technical knowledge, scientific creativity, and collaboration skills in the development and execution of research for the preparation of novel chemical substances Plan, execute and analyze laboratory experimentation to advance the knowledge of production and quality attributes of drug substances Propose alternative chemistry, including new route selection and step optimization Provide regular updates to supervision and proposes future research directions In collaboration with senior scientists, develops project strategy for manufacturing of drug substances to support clinical studies and commercialization Responsible for the day to day management of project team members and research assignments, including designing and interpreting of experimentation Prepare and review technical documents including research reports, process development reports, and documentation for the manufacturing of chemical substances e.g. Master Batch Records (MBRs) Collaborate across functional areas including analytical chemistry, quality assurance, and manufacturing to accomplish project goals. Acts as a subject matter expert for cross-functional teams and research personnel Provide technical support for manufacturing processes performed under cGMP in laboratory manufacturing and large-scale manufacturing operations Ensure that all experimentation is carried out in accordance with appropriate standard operating procedures (SOPs), maintaining quality, safety, and environmental standards

Requirements

• PhD in Organic Chemistry (or related discipline) and 5+ years of relevant experience minimum required. OR MSc degree with extensive industry experience (8+ years) OR BSc degree with extensive industry experience (10+ years)
• Experience in planning and executing multi-step synthesis of organic molecules
• Experience scaling up synthetic routes and developing safe processes
• Familiarity with purification and analytical techniques, including HPLC, LCMS and NMR
• 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

Nice To Haves

• Familiarity with pilot plant and/or plant operations, and experience with generating master batch records is an asset
• Familiarity with process validation, regulatory filings and cGMP regulatory guidelines is an asset
• Experience with project and people management is an asset

Responsibilities

• Be responsible for developing chemical processes for the manufacturing of drug substances
• Demonstrate technical knowledge, scientific creativity, and collaboration skills in the development and execution of research for the preparation of novel chemical substances
• Plan, execute and analyze laboratory experimentation to advance the knowledge of production and quality attributes of drug substances
• Propose alternative chemistry, including new route selection and step optimization
• Provide regular updates to supervision and proposes future research directions
• In collaboration with senior scientists, develops project strategy for manufacturing of drug substances to support clinical studies and commercialization
• Responsible for the day to day management of project team members and research assignments, including designing and interpreting of experimentation
• Prepare and review technical documents including research reports, process development reports, and documentation for the manufacturing of chemical substances e.g. Master Batch Records (MBRs)
• Collaborate across functional areas including analytical chemistry, quality assurance, and manufacturing to accomplish project goals.
• Acts as a subject matter expert for cross-functional teams and research personnel
• Provide technical support for manufacturing processes performed under cGMP in laboratory manufacturing and large-scale manufacturing operations
• Ensure that all experimentation is carried out in accordance with appropriate standard operating procedures (SOPs), maintaining quality, safety, and environmental standards

Benefits

• 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. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree