Description
Senior Research Scientist I - Process Safety and Development
KEY RESPONSIBILITIES
Manage site process safety operations including :
Providing training and guidance to process chemistry personnel in hazards evaluation of chemical processes in the laboratory,
Acting as process safety SME for other departments across all areas and levels,
Providing process safety assessments for active pharmaceutical ingredient (API) manufacturing performed under cGMP including documentation related to batch records and specifications.
Continue to develop the process safety evaluation system and procedures for the site, and act as a corporate resource on process safety issues.
Participate in the recruitment, selection, management, development, and evaluation of staff. Strong emphasis on developing colleagues, including mentorship of individuals and project teams.
FOCUS AREAS
Responsible for process safety assessments and investigations for the manufacturing of drug substances, including :
Use of appropriate methods and techniques (e.g., DSC, ARC, RC1) to support process development activities and other project goals,
Interpretation of data and presentation of process hazard evaluation results.
Responsible for the continuous improvement of process safety systems on site, and at the corporate level as required, with a particular focus on personnel and process safety.
Maintain alignment with corporate process safety goals, and direct personnel with interpretation of and compliance with process safety requirements.
Maintain full working knowledge of up-to-date, state-of-the art principles and theories, and regulatory guidance, and applying such knowledge to the development of personnel and systems.
Develop, manage, and promote site process safety programs and systems, including development of process safety assessment tools, training programs, and other tools to support site safety culture and performance.
QUALIFICATIONS
Ph.D. in chemistry (or related science or engineering) and 2+ years of relevant experience, or MS / MA in a related scientific discipline with 8+ years’ industry experience;
or BS / BA in a related scientific discipline with 10+ years’ industry experience
Pharmaceutical / fine chemical industry experience in process safety and development is preferred
Application of sound and scientific judgment to make timely decisions
Strong collaboration, communication, and writing skills are required
For Current Gilead Employees and Contractors :
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