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Research And Development Manager
2 months ago
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.
