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Title
Text copied to clipboard!CMC Senior Officer
Description
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We are looking for a highly skilled and experienced CMC Senior Officer to join our dynamic team. The ideal candidate will be responsible for overseeing and managing all Chemistry, Manufacturing, and Controls (CMC) activities related to pharmaceutical development and production. This role requires a deep understanding of regulatory requirements, quality control, and project management. The CMC Senior Officer will work closely with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure that all CMC activities are conducted in compliance with applicable regulations and standards. The successful candidate will have a proven track record in CMC project management, excellent communication skills, and the ability to lead and mentor junior staff. Key responsibilities include developing and implementing CMC strategies, managing timelines and budgets, and ensuring the successful submission of regulatory documents. The CMC Senior Officer will also be responsible for identifying and mitigating risks, troubleshooting issues, and continuously improving processes. This is a critical role that requires a high level of expertise, attention to detail, and the ability to work in a fast-paced environment. If you are passionate about pharmaceutical development and have the skills and experience we are looking for, we encourage you to apply.
Responsibilities
Text copied to clipboard!- Develop and implement CMC strategies for pharmaceutical development.
- Oversee and manage all CMC activities, including quality control and regulatory compliance.
- Collaborate with cross-functional teams to ensure project success.
- Manage timelines, budgets, and resources for CMC projects.
- Ensure successful submission of regulatory documents.
- Identify and mitigate risks related to CMC activities.
- Troubleshoot and resolve issues in CMC processes.
- Continuously improve CMC processes and procedures.
- Lead and mentor junior staff in CMC activities.
- Stay updated on regulatory requirements and industry trends.
Requirements
Text copied to clipboard!- Bachelor's degree in Chemistry, Pharmacy, or related field.
- Minimum of 5 years of experience in CMC project management.
- Deep understanding of regulatory requirements and quality control.
- Proven track record in managing CMC activities.
- Excellent communication and leadership skills.
- Strong project management skills.
- Ability to work in a fast-paced environment.
- Attention to detail and problem-solving skills.
- Experience with regulatory submissions.
- Ability to collaborate with cross-functional teams.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with CMC project management?
- How do you ensure compliance with regulatory requirements?
- Can you provide an example of a successful CMC project you managed?
- How do you handle risks and issues in CMC activities?
- What strategies do you use to improve CMC processes?
- How do you manage timelines and budgets for CMC projects?
- Can you describe your experience with regulatory submissions?
- How do you stay updated on industry trends and regulations?
- What is your approach to leading and mentoring junior staff?
- How do you collaborate with cross-functional teams?
