Senior Director, CMC

Neuraxpharm Group; United States; Remote; USD 150,000 - 200,000; Full time

Job summary

A leading company in biologics is seeking a Director - Executive Director for CMC Management. This remote role involves leading projects, collaborating with clients, and providing strategic guidance on product development. Ideal candidates will have extensive experience in the pharmaceutical industry and strong project management skills.

Qualifications

• 8-20 years of relevant experience in cell line development, CMC process development, or GMP manufacturing.
• Strong understanding of pharmaceutical industry and large molecule drug development.

Responsibilities

• Provide technical and portfolio leadership to support IND and BLA submissions.
• Lead CMC projects, ensuring compliance with regulatory and ICH guidelines.
• Support business development efforts to expand service offerings.

Skills

Communication

Project Management

Problem Solving

Education

PhD in Biochemistry

PhD in Molecular Biology

PhD in Biochemical/Chemical Engineering

Job description

Requisition ID: 4828 - Posted: Work From Home - United States

Job Title: Director - Executive Director, CMC Management

Company: WuXi Biologics, United States (Remote)

Summary:

We offer opportunities for roles from Director to Executive level, depending on experience. The role involves leading projects from proposal to completion by collaborating with clients, technical teams, and business development. The position also includes business development activities such as client visits and representing WuXi Biologics at conferences and trade shows.

Responsibilities:

1. Provide technical and portfolio leadership to support IND and BLA submissions, enabling CMC activities.
2. Collaborate with CMC teams to ensure successful project execution within scope, time, and budget.
3. Offer strategic and technical guidance on product development and manufacturing strategies.
4. Lead CMC projects, anticipating technical challenges and ensuring compliance with regulatory and ICH guidelines.
5. Serve as the decision-maker for technical issues and solutions.
6. Coordinate communication and efforts between WuXi Biologics and clients.
7. Work with a high-performance team to ensure quality, IP, and EHS compliance.
8. Support business development efforts to expand service offerings and attract new clients.

Qualifications:

1. PhD in Biochemistry, Molecular Biology, Biochemical/Chemical Engineering, or related fields.
2. Experience in large pharma or biotech sectors.
3. 8-20 years of relevant experience in cell line development, CMC process development, analytical sciences, or GMP manufacturing, depending on the role level.
4. Strong understanding of pharmaceutical industry and large molecule drug development.
5. Knowledge of current regulations and industry trends for biologics and ADC products.
6. Experience in biologics manufacturing.
7. Excellent communication skills in English and Chinese, and ability to work across functions and locations.
8. Proven project management and problem-solving skills, with cross-functional collaboration experience.
9. Experience in regulatory documentation and multi-project management.
10. CRO or CMO experience is preferred but not required.
11. Self-motivated, organized, detail-oriented, and flexible, with 10-15% travel expected.