Text copied to clipboard!
Title
Text copied to clipboard!CMC Senior Officer
Description
Text copied to clipboard!
We are looking for a CMC Senior Officer to join our pharmaceutical development team. The CMC (Chemistry, Manufacturing, and Controls) Senior Officer plays a critical role in ensuring that all aspects of drug development, manufacturing, and regulatory compliance are managed effectively and efficiently. This position requires a deep understanding of pharmaceutical processes, regulatory requirements, and quality assurance standards. The ideal candidate will be responsible for coordinating CMC activities across multiple projects, ensuring timely submission of regulatory documents, and maintaining high standards of product quality and safety.
The CMC Senior Officer will collaborate closely with cross-functional teams, including research and development, quality assurance, regulatory affairs, and manufacturing. Key responsibilities include preparing and reviewing CMC documentation for regulatory submissions (such as INDs, NDAs, and MAAs), managing change controls, and supporting technology transfer activities. The role also involves monitoring compliance with Good Manufacturing Practices (GMP), identifying process improvements, and ensuring that all CMC-related activities align with company and regulatory expectations.
Candidates should possess strong project management skills, attention to detail, and the ability to communicate complex technical information clearly to both internal and external stakeholders. Experience in working with global regulatory agencies and a thorough knowledge of ICH guidelines are highly desirable. The CMC Senior Officer will also be expected to stay updated on industry trends and regulatory changes to proactively address potential challenges in the development and manufacturing process. This is an excellent opportunity for a motivated professional to contribute to the successful development and commercialization of innovative pharmaceutical products.
Responsibilities
Text copied to clipboard!- Oversee CMC activities for pharmaceutical development projects
- Prepare and review CMC sections of regulatory submissions
- Ensure compliance with GMP and regulatory requirements
- Coordinate with cross-functional teams to support product development
- Manage change controls and technology transfer processes
- Monitor and improve manufacturing processes for quality and efficiency
- Stay updated on regulatory guidelines and industry best practices
- Support audits and inspections by regulatory agencies
- Identify and mitigate risks related to CMC activities
- Provide technical guidance to junior staff
Requirements
Text copied to clipboard!- Bachelor’s or Master’s degree in Pharmacy, Chemistry, or related field
- 5+ years of experience in CMC or pharmaceutical development
- Strong knowledge of GMP and regulatory requirements
- Experience with regulatory submissions (IND, NDA, MAA, etc.)
- Excellent project management and organizational skills
- Ability to communicate complex information clearly
- Attention to detail and strong analytical skills
- Experience working with cross-functional teams
- Familiarity with ICH guidelines
- Ability to manage multiple projects simultaneously
Potential interview questions
Text copied to clipboard!- What experience do you have with CMC regulatory submissions?
- How do you ensure compliance with GMP standards?
- Describe a challenging CMC project you managed.
- How do you stay updated on regulatory changes?
- What strategies do you use for effective cross-functional collaboration?
- Can you provide an example of process improvement you implemented?
- How do you handle tight deadlines and multiple projects?
- What is your experience with technology transfer?
- How do you approach risk management in CMC activities?
- What motivates you to work in pharmaceutical development?
