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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 innovative drug development.
- Benefits: Enjoy a competitive salary, potential contract extension, and the chance to work in a vibrant location.
- Why this job: Be part of a crucial role that shapes drug development and impacts patient lives globally.
- Qualifications: Must have a BS/MS in chemical engineering or chemistry and 10+ years in pharmaceutical development.
- Other info: This is an on-site position; 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
- Ensure robust supply chain and inventory management for APIs and drug products
- Develop budget and resource plans for CMC activities
- Mentor and develop team members in CMC group
Requirements:
- BS/MS in chemical engineering, chemistry or related field
- 10+ years experience in pharmaceutical drug product development
- Deep knowledge of cGMP regulations and industry best practices
- Leadership skills with ability to influence cross-functional teams
- Excellent communication and problem-solving abilities
- Understanding of pharmaceutical quality systems and regulatory compliance
- Knowledge of drug manufacturing processes, analytical methods, quality control testing, etc.
- Experience with regulatory submissions and agency interactions
This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply immediately as it is likely that recruitment will close prematurely.
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 drug product development.
✨Tip Number 2
Familiarise yourself with the specific cGMP regulations and quality standards that are prevalent in Switzerland. Understanding local compliance requirements can give you an edge during interviews and discussions with hiring managers.
✨Tip Number 3
Prepare to discuss your leadership experiences in detail. Be ready to provide examples of how you've successfully led cross-functional teams and driven projects to completion, as this role requires strong leadership skills.
✨Tip Number 4
Stay updated on recent advancements in pharmaceutical technologies and manufacturing processes. Being knowledgeable about innovative solutions can demonstrate your commitment to continuous improvement and align with the company's goals.
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 pharmaceutical drug product development, particularly in CMC activities. Emphasise your leadership skills and any specific achievements related to cGMP regulations.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your motivation for applying for the CMC Director position. Discuss how your background aligns with the responsibilities listed in the job description and mention any specific projects that demonstrate your expertise.
Highlight Regulatory Experience: Given the importance of regulatory documentation in this role, ensure you detail your experience with INDs, NDAs, and interactions with regulatory agencies. This will show your familiarity with the compliance landscape.
Showcase Leadership Skills: In your application, provide examples of how you've led cross-functional teams and driven continuous improvement initiatives. This will help illustrate your capability to manage and mentor team members effectively.
How to prepare for a job interview at Barrington James
✨Showcase Your Leadership Experience
As a CMC Director, you'll need to demonstrate your leadership skills. Prepare examples of how you've successfully led cross-functional teams in the past, particularly in high-stakes projects. Highlight your ability to influence and motivate others.
✨Understand Regulatory Requirements
Given the importance of cGMP regulations in this role, make sure you brush up on the latest guidelines and best practices. Be ready to discuss your experience with regulatory submissions and interactions with agencies, as this will be crucial in the interview.
✨Prepare for Technical Questions
Expect to face technical questions related to drug manufacturing processes, analytical methods, and quality control testing. Review your knowledge in these areas and be prepared to discuss specific challenges you've encountered and how you overcame them.
✨Demonstrate Strategic Thinking
The role requires developing integrated CMC strategies aligned with business goals. Be prepared to discuss how you've approached strategic planning in previous roles, including how you managed budgets and timelines while ensuring compliance and quality.
