Research And Development Manager

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.
• GMP’s, 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.