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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.
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 organized and detail-oriented.
Opportunities:
- Broaden knowledge and experience in the field of biopharmaceutical industry from drug discovery, development and commercialization.
- 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 will help you understand the current trends and challenges in the field.
✨Tip Number 2
Familiarise yourself with the latest regulations and guidelines related to large molecules, particularly bispecific antibodies and antibody-drug conjugates. This knowledge will not only enhance your credibility but also demonstrate your commitment to staying updated in the industry.
✨Tip Number 3
Showcase your project management skills by discussing specific examples of how you've successfully led CMC projects in the past. Highlight your ability to coordinate teams and manage multiple projects simultaneously, as this is crucial for the role.
✨Tip Number 4
If you have any basic knowledge of Chinese, make sure to mention it during your interactions. This could be a valuable asset in a global company like WuXi Biologics, where communication with diverse teams is essential.
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 enthusiasm for the role and how your background in biochemistry or related fields makes you a strong candidate. Mention your experience with regulatory requirements and project management, as these are key aspects of the job.
Showcase Communication Skills: Since excellent verbal and written communication skills are essential, consider including examples of how you've effectively communicated complex information in previous roles. This could be through presentations, reports, or client interactions.
Highlight Strategic Thinking: Demonstrate your strategic thinking abilities by discussing past experiences where you successfully navigated technical challenges or contributed to business development. This will show that you can provide the technical guidance needed for the role.
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 effective collaboration across various teams. Share examples of how you've successfully led cross-functional teams in the past, ensuring alignment and communication between different stakeholders, including clients and technical teams.
✨Demonstrate Strategic Thinking
Prepare to discuss your approach to strategic planning in project management. Highlight instances where your strategic insights have led to successful project outcomes, particularly in relation to IND and BLA submissions.
✨Prepare for Business Development Discussions
Since the role involves business development activities, be ready to talk about your experience in promoting services at conferences or trade shows. Discuss how you've built relationships with clients and contributed to expanding service offerings in your previous roles.
