Job Description

GL Staffing Services is seeking an experienced Research and Development Manager to lead and oversee analytical and product development for various pharmaceutical dosage forms.

Range from 80k-85k a year

Key Responsibilities: Research and Development Manager

• Lead product development and transfer to manufacturing operations.
• Develop, qualify, validate, and transfer analytical test methods.
• Implement and manage a cleaning validation program.
• Manage a team of scientists, analysts, and technicians, providing guidance and support.
• GMPs, FDA/BOP guidelines and expectations, ICH standards.
• Scientific guidance on complex manufacturing investigations and resolution of out-of-specification and out-of-trend testing results.
• Ensure compliance with FDA, GMP, ICH, and company SOP standards.
• Author and review key documents, including SOPs, validation protocols, and reports.
• Provide technical support for manufacturing investigations and regulatory agency interactions.

Requirements: Research and Development Manager

• MS or Ph.D. in Chemistry with 5+ years of analytical development experience in pharmaceuticals.
• 2+ years of leadership experience in an analytical or pharmaceutical lab setting.
• Strong knowledge of analytical, organic, and physical chemistry.
• Experience with cGMP, FDA guidelines, and ICH standards.
• Excellent communication, leadership, and problem-solving skills.
• Proficiency in Microsoft Office and relevant lab software.

Physical Requirements:

• Ability to travel for business purposes.
• Flexible working hours to meet job demands.
• Ability to sit or stand for long periods and wear necessary protective equipment as a Researcher.

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