Text copied to clipboard!

Title

Text copied to clipboard!

CMC Senior Officer

Description

Text copied to clipboard!
We are looking for a highly skilled 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 drug substance and drug product processes, analytical methods, and product formulations. The CMC Senior Officer will also be responsible for ensuring compliance with all regulatory requirements and guidelines. This role requires a strong understanding of pharmaceutical development, manufacturing, and quality control processes. The ideal candidate will have a proven track record in CMC management, excellent leadership skills, and the ability to work effectively in a fast-paced, dynamic environment.

Responsibilities

Text copied to clipboard!
  • Develop and implement CMC strategies for drug substance and drug product processes.
  • Ensure compliance with all regulatory requirements and guidelines.
  • Manage CMC related activities and projects.
  • Coordinate with cross-functional teams to ensure project timelines are met.
  • Oversee the development and validation of analytical methods.
  • Manage the preparation and submission of CMC regulatory documents.
  • Ensure the quality and integrity of CMC data and documentation.
  • Provide technical guidance and support to the CMC team.
  • Monitor and evaluate the performance of CMC processes and systems.
  • Stay up-to-date with the latest developments in CMC regulations and industry best practices.

Requirements

Text copied to clipboard!
  • Bachelor's degree in Chemistry, Pharmacy, or related field.
  • Minimum of 5 years of experience in CMC management.
  • Strong knowledge of pharmaceutical development, manufacturing, and quality control processes.
  • Excellent leadership and project management skills.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a fast-paced, dynamic environment.
  • Strong knowledge of CMC regulations and industry best practices.
  • Proficiency in Microsoft Office Suite.
  • Ability to travel as needed.

Potential interview questions

Text copied to clipboard!
  • Can you describe your experience with CMC management?
  • How do you ensure compliance with CMC regulations and guidelines?
  • Can you describe a time when you had to manage a complex CMC project?
  • How do you handle pressure and tight deadlines?
  • Can you describe your experience with the preparation and submission of CMC regulatory documents?