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- Tasks: Lead CMC projects, ensuring timely delivery and regulatory compliance.
- Company: Join WuXi Biologics, a leader in biopharmaceutical services.
- Benefits: Enjoy remote work flexibility and opportunities for travel.
- Why this job: Make an impact in drug development while enhancing your leadership skills.
- Qualifications: Ph.D. or MSc. in relevant fields with 5-15 years of industry experience required.
- Other info: This is a home-based role with occasional travel; basic Chinese knowledge preferred.
The predicted salary is between 72000 - 108000 £ per year.
Oversight of projects from the proposal stage through project completion by interacting with the client, technical team, and business development team. The position will also participate in business development activities such as visiting clients and promoting WuXi Biologic’s services at conferences/trade shows.
Responsibilities:
- Provide technical and portfolio leadership to support IND and BLA, enabling CMC activities.
- Collaborate with CMC functional areas to ensure the successful execution of various CMC projects and the delivery of results on time and within budget.
- Provide strategic thinking and technical guidance for the project teams, in product development and manufacturing strategy.
- Lead CMC projects with a good understanding of potential technical challenges and meeting the regulatory requirements and ICH’s guidelines.
- Coordinate efforts and facilitate communication to ensure alignment between WuXi Biologics and clients.
- Work with a high-performance team to ensure the best quality services, IP, and EHS compliance.
- Support corporate business development to enhance the current service offering and develop new clients.
Qualifications:
- Advanced degree (Ph.D. or MSc.) in Biochemistry, Molecular Biology, Biochemical/Chemical Engineering or related discipline.
- A minimum of 5-15 years of relevant pharmaceutical or biotech industry experience in cell line development, CMC process development, analytical sciences, and/or GMP manufacturing.
- Demonstrates good understanding of current regulations and industry trends for large molecules including but not limited to bispecific antibody and antibody drug conjugates.
- Ability to effectively work in a matrix organization across functions and sites.
- Ability to plan & prioritise and handle multiple CMC projects at a time.
- Excellent verbal and written communication skills in English. Basic knowledge in Chinese is preferred.
- Strategic view and leadership abilities as well as hands-on problem-solving skills.
- Experience in project management is required.
- Must be a self-starter, self-motivated, and highly flexible in this home-based position with about 10%-15% travel.
- Must be organised and detail-oriented.
Opportunities:
- Broaden knowledge and experience in the field of biopharmaceutical industry from drug discovery, development and commercialisation.
- Develop and enhance leadership skills in people and project management.
- Strengthen interpersonal and communication skills.
- Build up business acumen and network collaboration.
CMC Director employer: WuXi Biologics
Contact Detail:
WuXi Biologics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CMC Director
✨Tip Number 1
Network with professionals in the biopharmaceutical industry, especially those who have experience in CMC roles. Attend relevant conferences and trade shows to meet potential colleagues and clients, as this can help you gain insights into the company culture and expectations.
✨Tip Number 2
Familiarise yourself with the latest regulations and industry trends related to large molecules, particularly bispecific antibodies and antibody-drug conjugates. This knowledge will not only enhance your discussions during interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 3
Showcase your project management skills by preparing examples of how you've successfully led CMC projects in the past. Be ready to discuss specific challenges you faced and how you overcame them, as this will highlight your problem-solving abilities and strategic thinking.
✨Tip Number 4
If you have any basic knowledge of Chinese, make sure to mention it during your conversations. This could be a valuable asset for the role, especially when collaborating with teams or clients that operate in Chinese-speaking regions.
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 the pharmaceutical or biotech industry, particularly in CMC activities. Emphasise your leadership roles and any specific projects that align with the responsibilities of the CMC Director position.
Craft a Compelling Cover Letter: In your cover letter, express your passion for biopharmaceuticals and detail how your background in project management and technical leadership makes you an ideal candidate. Mention your understanding of regulatory requirements and your ability to navigate complex projects.
Showcase Communication Skills: Since excellent verbal and written communication skills are essential for this role, consider including examples of how you've effectively communicated with clients and teams in previous positions. This could be through successful presentations or collaborative projects.
Highlight Strategic Thinking: Demonstrate your strategic thinking abilities by discussing past experiences where you provided technical guidance or led projects that required innovative solutions. This will show your potential employer that you can contribute to their business development efforts.
How to prepare for a job interview at WuXi Biologics
✨Showcase Your Technical Expertise
As a CMC Director, you'll need to demonstrate a strong understanding of biochemistry and regulatory requirements. Be prepared to discuss your previous experiences in cell line development and CMC process development, highlighting specific projects where you overcame technical challenges.
✨Emphasise Leadership and Collaboration
This role requires leading cross-functional teams. Share examples of how you've successfully coordinated efforts between different departments or stakeholders in past projects. Highlight your strategic thinking and ability to motivate a high-performance team.
✨Prepare for Business Development Discussions
Since the position involves promoting services and visiting clients, be ready to discuss your experience in business development. Think of ways you've successfully enhanced service offerings or developed new client relationships in your previous roles.
✨Demonstrate Organisational Skills
With multiple projects to manage, it's crucial to show that you're organised and detail-oriented. Prepare to explain your methods for prioritising tasks and managing time effectively, especially in a fast-paced environment.
