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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 organised 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 gain insights into the latest trends and challenges in the field.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements 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 past experiences where you successfully led multiple CMC projects. Highlight your ability to plan, prioritise, and navigate challenges, as these are crucial for the role of CMC Director.
✨Tip Number 4
If you have basic knowledge of Chinese, make sure to mention it during networking or interviews. This could set you apart from other candidates and show your willingness to engage with a broader range of clients and partners.
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 process development and project management. Use specific examples that demonstrate your leadership abilities and technical expertise.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role of CMC Director at WuXi Biologics. Discuss how your background aligns with their needs, particularly your experience with IND and BLA support, and your understanding of regulatory requirements.
Showcase Communication Skills: Since excellent verbal and written communication skills are essential for this role, ensure your application is well-written and free of errors. Consider including examples of how you've effectively communicated complex information in previous roles.
Highlight Strategic Thinking: Demonstrate your strategic thinking capabilities by providing examples of how you've successfully led projects or teams in the past. Discuss any challenges you faced and how you overcame them to achieve project goals.
How to prepare for a job interview at WuXi Biologics
✨Showcase Your Technical Expertise
As a CMC Director, you'll need to demonstrate your deep understanding of biochemistry and related fields. Be prepared to discuss specific projects you've led, the challenges you faced, and how you navigated regulatory requirements.
✨Highlight Leadership Experience
This role requires strong leadership skills. Share examples of how you've successfully managed teams and projects in the past, particularly in a matrix organisation. Emphasise your ability to motivate and guide others towards achieving project goals.
✨Demonstrate Strategic Thinking
Prepare to discuss your approach to strategic planning in CMC activities. Illustrate how you've contributed to product development and manufacturing strategies, and how your insights have led to successful outcomes in previous roles.
✨Communicate Effectively
Excellent communication skills are crucial for this position. Practice articulating complex technical concepts clearly and concisely. Be ready to explain how you've facilitated communication between different teams and clients to ensure alignment on project objectives.
