CMC Director

JR United Kingdom; Sheffield; On-site; GBP 70,000 - 120,000; Full time

Job summary

A leading company in the biotechnology sector is seeking a CMC Director in Sheffield. In this role, you will provide technical leadership and manage projects from proposal to completion, ensuring compliance and high-quality standards. The ideal candidate will have substantial experience in the biotech industry, particularly in CMC-related activities, and possess strong leadership and communication skills.

Qualifications

• 5-15 years of relevant experience in pharmaceutical or biotech industry.
• Good understanding of regulations for large molecules like bispecific antibodies.
• Ability to manage multiple projects effectively.

Responsibilities

• Oversee projects from proposal to completion.
• Collaborate to ensure successful project execution within budget.
• Lead CMC projects and anticipate technical challenges.

Skills

Leadership

Strategic Thinking

Problem Solving

Project Management

English Communication

Basic Chinese Knowledge

Education

Ph.D. or MSc. in Biochemistry, Molecular Biology, Biochemical/Chemical Engineering

Job description

Social network you want to login/join with:

CMC Director, Sheffield, South Yorkshire

Client:

WuXi Biologics

Location:

Sheffield, South Yorkshire, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Views:

3

Posted:

06.06.2025

Expiry Date:

21.07.2025

Job Description:

Summary:

Oversight of projects from proposal to completion by interacting with clients, technical teams, and business development teams. Participate in business development activities such as visiting clients and promoting WuXi Biologics’ services at conferences and trade shows.

Responsibilities:

• Provide technical and portfolio leadership to support IND and BLA, enabling CMC activities.
• Collaborate with CMC functional areas to ensure successful execution of projects within budget and timeline.
• Offer strategic and technical guidance for product development and manufacturing strategies.
• Lead CMC projects, understanding potential technical challenges and regulatory requirements.
• Coordinate efforts and facilitate communication between WuXi Biologics and clients.
• Ensure high-quality services, IP, and EHS compliance within a high-performance team.
• Support business development to expand current services and acquire new clients.

Qualifications:

• Advanced degree (Ph.D. or MSc.) in Biochemistry, Molecular Biology, Biochemical/Chemical Engineering, or related fields.
• 5-15 years of relevant experience in pharmaceutical or biotech industry, including cell line development, CMC process development, analytical sciences, or GMP manufacturing.
• Good understanding of regulations and industry trends for large molecules like bispecific antibodies and ADCs.
• Ability to work effectively across functions and sites, managing multiple projects.
• Excellent English communication skills; basic Chinese knowledge preferred.
• Leadership, strategic thinking, problem-solving, and project management skills.
• Self-motivated, organized, flexible, and capable of travel (~10-15%).
• Broad knowledge in biopharmaceutical development from discovery to commercialization.