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Title
Text copied to clipboard!CMC Officer
Description
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We are looking for a dedicated and detail-oriented CMC Officer to join our team. The CMC Officer plays a critical role in the pharmaceutical and biotechnology industries, ensuring that all aspects of Chemistry, Manufacturing, and Controls (CMC) are compliant with regulatory standards and support the development and commercialization of safe and effective products. This position requires a deep understanding of regulatory guidelines, manufacturing processes, and quality control measures. The CMC Officer will collaborate with cross-functional teams, including research and development, quality assurance, regulatory affairs, and manufacturing, to ensure that all CMC-related activities are aligned with project timelines and objectives.
The ideal candidate will have a strong background in pharmaceutical sciences, chemistry, or a related field, coupled with experience in regulatory submissions and manufacturing processes. They will be responsible for preparing and reviewing CMC documentation for regulatory submissions, managing technical data, and ensuring compliance with Good Manufacturing Practices (GMP). The role also involves troubleshooting manufacturing issues, optimizing processes, and staying updated on the latest regulatory requirements and industry trends.
This is an excellent opportunity for a professional who is passionate about contributing to the development of life-saving therapies and ensuring their quality and safety. If you have a keen eye for detail, strong organizational skills, and a commitment to excellence, we encourage you to apply.
Responsibilities
Text copied to clipboard!- Prepare and review CMC documentation for regulatory submissions.
- Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory standards.
- Collaborate with cross-functional teams to align CMC activities with project timelines.
- Troubleshoot and resolve manufacturing and quality control issues.
- Optimize manufacturing processes to improve efficiency and product quality.
- Stay updated on regulatory guidelines and industry trends.
- Manage technical data and ensure accurate documentation.
- Support audits and inspections related to CMC activities.
Requirements
Text copied to clipboard!- Bachelor's or Master's degree in pharmaceutical sciences, chemistry, or a related field.
- Experience in CMC documentation and regulatory submissions.
- Strong knowledge of Good Manufacturing Practices (GMP).
- Excellent organizational and project management skills.
- Ability to work collaboratively with cross-functional teams.
- Strong analytical and problem-solving skills.
- Attention to detail and commitment to quality.
- Familiarity with regulatory guidelines such as FDA, EMA, or ICH.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with CMC documentation and regulatory submissions?
- How do you ensure compliance with GMP and other regulatory standards?
- Can you provide an example of a manufacturing issue you resolved?
- How do you stay updated on the latest regulatory guidelines and industry trends?
- What strategies do you use to manage technical data and ensure accurate documentation?
- How do you handle tight project timelines and competing priorities?
- What experience do you have with audits and inspections related to CMC activities?
- Can you describe a time when you optimized a manufacturing process?