Lead Process Scientist Drug Substance

Proclinical is seeking a Lead Process Scientist Drug Substance to support the transfer and optimization of drug substance manufacturing processes. This role focuses on ensuring process readiness, regulatory compliance, and addressing any gaps in process design or control strategies. You will collaborate with cross-functional teams to ensure the successful transition of new products from development to manufacturing.

Responsibilities

• Lead the transfer of drug substance manufacturing processes from development to production.
• Ensure process knowledge and control strategies are robust, cost-effective, safe, and compliant.
• Prepare and review documentation to support process design for regulatory submissions.
• Identify and address gaps in process design and control strategies prior to commercial manufacturing.
• Analyze process data to identify areas for improvement or concern.
• Provide technical reviews of upstream and downstream drug substance processes.
• Guide the remediation of process design gaps using scientific principles and product knowledge.
• Present findings and proposed actions to stakeholders, including leadership and global teams.
• Communicate project status to management and key stakeholders through appropriate channels.
• Influence and align stakeholders to drive informed, data-driven decisions.

Key Skills and Requirements

• Strong understanding of drug substance unit operations and CMC activities.
• Ability to analyze complex data and regulatory expectations to make informed decisions.
• Skilled in process monitoring, data analysis, and identifying improvement opportunities.
• Effective communicator with the ability to present clear, structured messages to diverse audiences.
• Proven ability to influence cross-functional teams and leadership.
• Degree in a scientific, pharmaceutical, or engineering discipline (MSc or PhD preferred).
• Proficiency in English.

If you are having difficulty in applying or if you have any questions, please contact Numhom Sudsok at .

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Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Science

Industries

• Professional Services

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