CMC Director

CMC Director

Luton Full-Time 72000 - 108000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead CMC projects, ensuring timely delivery and regulatory compliance.
  • Company: Join WuXi Biologics, a leader in biopharmaceutical services.
  • Benefits: Enjoy flexible working conditions with opportunities for travel and networking.
  • Why this job: Make an impact in drug development while enhancing your leadership and communication skills.
  • Qualifications: Ph.D. or MSc. in relevant fields with 5-15 years of industry experience required.
  • Other info: Home-based role with occasional travel; ideal for self-starters.

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

WuXi Biologics is an exceptional employer that fosters a dynamic and collaborative work culture, where innovation and excellence are at the forefront of our mission. As a CMC Director, you will have the opportunity to lead high-impact projects in the biopharmaceutical industry while benefiting from extensive professional development and networking opportunities. Our commitment to employee growth, coupled with a supportive environment that values strategic thinking and technical expertise, makes WuXi Biologics a rewarding place to advance your career.
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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, such as bispecific antibodies and antibody-drug conjugates. This knowledge will not only enhance your understanding 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 CMC Director role.

✨Tip Number 4

If you have basic knowledge of Chinese, make sure to mention it during conversations or interviews. 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

Technical Leadership
Project Management
Regulatory Knowledge
Strategic Thinking
Communication Skills
Collaboration Skills
Problem-Solving Skills
Biochemistry Expertise
Molecular Biology Knowledge
GMP Manufacturing Experience
Analytical Sciences Proficiency
Cell Line Development Experience
Time Management
Detail-Oriented
Business Development Acumen

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: Write a cover letter that not only outlines your qualifications but also expresses your enthusiasm for the role. Mention how your background aligns with the responsibilities of overseeing projects and collaborating with various teams.

Showcase Communication Skills: Since excellent verbal and written communication skills are essential for this role, consider including examples of successful presentations or reports you've delivered in previous positions. This will help demonstrate your ability to communicate effectively across functions.

Highlight Strategic Thinking: In your application, emphasise your strategic thinking and problem-solving skills. Provide examples of how you've navigated challenges in past projects, particularly in relation to regulatory requirements and industry trends.

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 your experience with large molecules and any relevant industry trends.

✨Emphasise Leadership and Collaboration

This role requires strong leadership skills and the ability to work across various functions. Share examples of how you've successfully led teams in a matrix organisation and facilitated communication between different stakeholders. Illustrate your strategic thinking and problem-solving abilities.

✨Prepare for Business Development Discussions

Since the position involves business development activities, be ready to talk about your experience in promoting services and building client relationships. Discuss any past experiences where you've successfully enhanced service offerings or developed new clients, especially in a conference or trade show setting.

✨Demonstrate Organisational Skills

With multiple CMC projects to manage, showcasing your organisational skills is crucial. Prepare to explain how you prioritise tasks, manage timelines, and ensure project delivery within budget. Provide examples of how you've maintained attention to detail while juggling various responsibilities.

CMC Director
WuXi Biologics
Location: Luton
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