Lead Research Scientist

4 weeks ago

Edmonton, Alberta, Canada Gilead Alberta ULC Full time

Job Overview

Senior Research Scientist I - Process Safety and Development

KEY RESPONSIBILITIES

  • Oversee site process safety initiatives, including:
  • Delivering training and support to process chemistry teams regarding hazard assessments of chemical operations in laboratory settings,
  • Serving as the process safety Subject Matter Expert (SME) for various departments across all organizational levels,
  • Conducting process safety evaluations for active pharmaceutical ingredient (API) production under current Good Manufacturing Practices (cGMP), including relevant documentation associated with batch records and specifications.
  • Further develop the process safety evaluation framework and protocols for the site, while acting as a corporate resource on process safety matters.
  • Engage in the recruitment, selection, management, development, and assessment of personnel, with a strong focus on mentoring colleagues and project teams.

FOCUS AREAS

  • Accountable for process safety evaluations and investigations related to the production of drug substances, including:
  • Utilizing appropriate methodologies and techniques (e.g., DSC, ARC, RC1) to support process development initiatives and other project objectives,
  • Analyzing data and presenting findings from process hazard evaluations.
  • Responsible for the ongoing enhancement of process safety systems both on-site and at the corporate level, with a particular emphasis on personnel and process safety.
  • Ensure alignment with corporate process safety objectives, guiding personnel in the interpretation and adherence to process safety regulations.
  • Maintain comprehensive knowledge of contemporary principles, theories, and regulatory guidelines, applying this expertise to the development of personnel and systems.
  • Design, implement, and advocate for site process safety programs and systems, including the creation of process safety assessment tools, training initiatives, and other resources to bolster site safety culture and performance.

QUALIFICATIONS

  • Ph.D. in chemistry (or a related scientific or engineering discipline) with 2+ years of pertinent experience, or MS/MA in a related scientific field with 8+ years of industry experience; or BS/BA in a related scientific discipline with 10+ years of industry experience.
  • Experience in the pharmaceutical or fine chemical industry, particularly in process safety and development, is preferred.
  • Ability to apply sound scientific judgment for timely decision-making.
  • Strong collaboration, communication, and writing skills are essential.

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