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- Tasks: Lead CMC activities for pharmaceutical products from development to manufacturing.
- Company: Join a dynamic pharmaceutical company based in Switzerland, focused on innovation.
- Benefits: Enjoy a competitive salary, potential contract extension, and the chance to work in a vibrant location.
- Why this job: Be at the forefront of drug development and make a real impact in healthcare.
- Qualifications: Must have experience in CMC leadership and a strong understanding of regulatory requirements.
- Other info: This is an on-site role, so applicants must be located in Europe.
The predicted salary is between 72000 - 108000 £ per year.
The CMC Director will provide strategic leadership and oversight for all CMC activities, from early-stage development through commercial manufacturing, for pharmaceutical drug products. This is an initial 16 month contract with the view to extend. All applicants MUST be situated in Europe. The opportunity is on-site in Switzerland.
Responsibilities:
- Develop and implement integrated CMC strategies aligned with overall business goals, timelines and budgets
- Lead CMC teams across process chemistry, analytical development, formulation development, manufacturing, quality, regulatory affairs, etc.
- Oversee development, qualification, validation, tech transfer and manufacturing of APIs and drug products
- Ensure manufacturing processes, test methods, facilities, equipment and materials comply with cGMP regulations
- Author and critically review regulatory documentation like INDs, NDAs, DSURs, CMC sections, etc.
- Interact with regulatory agencies on CMC and quality topics
- Drive continuous improvement initiatives to enhance efficiency and reduce costs
- Implement new technologies to improve manufacturing and supply chain capabilities
- Manage capital projects for new facilities, equipment, systems, etc.
- Select and manage relationships with contract manufacturing organisations
CMC Director employer: Barrington James
Contact Detail:
Barrington James Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CMC Director
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those who have experience in CMC roles. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends in CMC activities.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements in Europe, particularly cGMP regulations. Understanding these guidelines will not only enhance your knowledge but also demonstrate your commitment to compliance during interviews.
✨Tip Number 3
Prepare to discuss your experience with cross-functional teams, as collaboration is key in CMC roles. Be ready to share examples of how you've successfully led teams across different areas such as process chemistry and quality assurance.
✨Tip Number 4
Research StudySmarter's values and mission to align your application with our company culture. Highlight how your strategic leadership style and experience can contribute to our goals, making you a standout candidate for the CMC Director position.
We think you need these skills to ace CMC Director
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in CMC activities, particularly in pharmaceutical drug products. Emphasise your leadership roles and any specific achievements in process chemistry, analytical development, or regulatory affairs.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your strategic vision for CMC activities. Mention how your past experiences align with the responsibilities listed in the job description, such as leading teams and managing relationships with contract manufacturing organisations.
Highlight Regulatory Expertise: Since the role involves authoring and reviewing regulatory documentation, ensure you detail your experience with INDs, NDAs, and other regulatory submissions. This will demonstrate your capability to interact effectively with regulatory agencies.
Showcase Continuous Improvement Initiatives: Include examples of how you've driven continuous improvement initiatives in previous roles. Highlight any technologies you've implemented that improved manufacturing processes or supply chain capabilities, as this is a key aspect of the position.
How to prepare for a job interview at Barrington James
✨Understand CMC Fundamentals
Make sure you have a solid grasp of the core concepts related to Chemistry, Manufacturing, and Controls (CMC). Be prepared to discuss how these elements integrate into the drug development process and how they align with business goals.
✨Showcase Leadership Experience
As a CMC Director, you'll be leading diverse teams. Highlight your previous leadership roles and provide examples of how you've successfully managed cross-functional teams in the past, particularly in high-pressure environments.
✨Familiarise Yourself with Regulatory Requirements
Since the role involves interacting with regulatory agencies, brush up on the relevant regulations and guidelines, such as cGMP and documentation requirements for INDs and NDAs. Being able to discuss these confidently will demonstrate your expertise.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and decision-making abilities. Think of specific challenges you've faced in previous roles and how you overcame them, especially in relation to manufacturing processes and quality assurance.
