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Title
Text copied to clipboard!CMC Senior Officer
Description
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We are looking for a dedicated and experienced CMC Senior Officer to join our team. The successful candidate will be responsible for overseeing and managing all Chemistry, Manufacturing, and Controls (CMC) related activities. This includes the development and implementation of strategies for the successful submission of CMC sections of regulatory filings, ensuring compliance with all applicable regulations and guidelines. The CMC Senior Officer will also be responsible for the management of CMC project teams, providing leadership and guidance to ensure the successful completion of projects. The ideal candidate will have a strong background in pharmaceutical development, with a particular focus on CMC. They will also have excellent leadership and project management skills, with the ability to effectively manage multiple projects and teams.
Responsibilities
Text copied to clipboard!- Oversee and manage all CMC related activities.
- Develop and implement strategies for the successful submission of CMC sections of regulatory filings.
- Ensure compliance with all applicable regulations and guidelines.
- Manage CMC project teams, providing leadership and guidance.
- Coordinate with other departments to ensure the successful completion of projects.
- Monitor and report on the progress of CMC projects.
- Identify and manage risks associated with CMC activities.
- Provide technical expertise and guidance on CMC related issues.
- Stay up-to-date with the latest developments in the field of CMC.
- Participate in regulatory inspections and audits.
Requirements
Text copied to clipboard!- Bachelor's degree in Chemistry, Pharmacy, or a related field.
- Minimum of 5 years of experience in pharmaceutical development, with a focus on CMC.
- Strong knowledge of CMC regulations and guidelines.
- Excellent leadership and project management skills.
- Ability to effectively manage multiple projects and teams.
- Strong problem-solving skills.
- Excellent communication and interpersonal skills.
- Ability to work under pressure and meet deadlines.
- Strong attention to detail.
- Proficiency in Microsoft Office Suite.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with CMC related activities?
- How do you manage multiple projects and teams?
- Can you describe a time when you had to solve a complex problem related to CMC?
- How do you stay up-to-date with the latest developments in the field of CMC?
- Can you describe your experience with regulatory inspections and audits?