Senior Scientist, Process Development

Responsible for developing chemical processes for the manufacturing of drug substances

Demonstrates technical knowledge, scientific creativity, and collaboration skills in the development and execution of research for the preparation of novel chemical substances

Plans, executes and analyzes laboratory experimentation to advance the knowledge of production and quality attributes of drug substances

Proposes alternative chemistry, including new route selection and step optimization

Provides 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

Prepares and reviews technical documents including research reports, process development reports, and documentation for the manufacturing of chemical substances e.g. Master Batch Records (MBRs)

Collaborates 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

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

PhD in Organic Chemistry (or related discipline) and 2+ years of relevant experience minimum required. We prefer a PhD with 2-10 years ideally, level will be commensurate with experience OR

MSc/BSc degree with extensive industry experience (6-8+ 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

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

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

Experience with project and people management is an asset