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Title

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CMC Officer

Description

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We are looking for a dedicated and experienced CMC Officer to join our team. The CMC Officer will be responsible for overseeing all aspects of Chemistry, Manufacturing, and Controls (CMC) for our pharmaceutical products. This includes the development and implementation of strategies for the manufacture and control of drug substances and products, ensuring compliance with regulatory requirements, and managing relationships with external partners and suppliers. The successful candidate will have a strong background in pharmaceutical manufacturing and a deep understanding of regulatory requirements for CMC. They will be a strategic thinker with excellent problem-solving skills and the ability to work effectively in a fast-paced, dynamic environment.

Responsibilities

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  • Develop and implement CMC strategies for drug substances and products
  • Ensure compliance with regulatory requirements for CMC
  • Manage relationships with external partners and suppliers
  • Oversee the manufacture and control of drug substances and products
  • Work closely with internal teams to ensure the successful execution of CMC strategies
  • Monitor industry trends and developments in CMC
  • Provide expert advice and guidance on CMC issues
  • Prepare and review regulatory submissions for CMC
  • Manage and mentor a team of CMC professionals
  • Ensure the continuous improvement of CMC processes and systems

Requirements

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  • Bachelor's degree in Chemistry, Pharmacy, or a related field
  • Minimum of 10 years' experience in pharmaceutical manufacturing
  • Deep understanding of regulatory requirements for CMC
  • Strong strategic thinking and problem-solving skills
  • Excellent communication and interpersonal skills
  • Ability to work effectively in a fast-paced, dynamic environment
  • Strong leadership and team management skills
  • Experience with regulatory submissions for CMC
  • Proficiency in Microsoft Office and other relevant software
  • Willingness to travel as required

Potential interview questions

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  • Can you describe your experience with regulatory submissions for CMC?
  • How do you ensure compliance with regulatory requirements for CMC?
  • Can you describe a time when you had to develop and implement a CMC strategy?
  • How do you manage relationships with external partners and suppliers?
  • Can you describe a time when you had to solve a complex problem related to CMC?