Executive Director, CMC

WuXi Biologics Group; United States; Remote; USD 150,000 - 250,000; Full time

Job summary

A leading company in biologics is seeking an Executive Director for CMC Management. This role involves leading project progression, providing technical leadership for CMC activities, and ensuring high-quality service while collaborating with clients and internal teams. The ideal candidate will have extensive experience in the pharma/biotech industry and strong communication skills in English and Chinese.

Qualifications

• 10-20 years of relevant experience in pharma/biotech.
• Experience in regulatory document writing and managing multiple projects.

Responsibilities

• Lead project progression from proposal to completion.
• Provide technical and portfolio leadership for IND and BLA CMC activities.
• Ensure high-quality service, IP protection, and EHS compliance.

Skills

Communication

Project Management

Problem Solving

Education

PhD in relevant fields

Job description

A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.

Discover information about the various drug development services we provide for this product type

Recombinant Proteins / Enzymes / Cytokines

Discover information about the various drug development services we provide for this product type

High quality, expert services for biologics produced from microbial fermentation.

Discover information about the various drug development services we provide for this product type

Industry-leading expertise, state-of-the-art facilities, and multiple antibody generation technology platforms for the discovery of novel monoclonal, bispecific and multispecific antibodies, immunocytokines and other biologics.

Specializing in monoclonal, bispecific, and multi-specific antibodies, fusion-proteins, cytokines, enzymes, and other biologics, we offer high productivity and high-quality antibody and protein production services for research needs.

We combine expert protein engineering with high throughput, research-scale protein production to support R&D initiatives.

WuXi Biologics offers extensive expertise in cell line engineering and strain development, as well as analytical testing, process development, and regulatory support, all tailored for your product needs.

Our services include late-stage development, process characterization, GMP manufacturing, drug product formulation, fill, labelling, packaging, and biosafety testing, with global regulatory compliance and a strong track record.

We support over 370 INDs/CTAs, 20+ BLAs/MAAs/NDAs/EUAs, and 150 Module 3 CMC packages since 2015, with dedicated teams for regulatory affairs and quality assurance.

Our facilities operate under cGMP standards for biologics and vaccines, with multiple large-scale and flexible manufacturing sites worldwide.

Additional services include assay development, analytical testing, viral clearance, and specialized testing throughout the product lifecycle to ensure readiness for commercialization.

Our teams uphold the highest quality standards, embedding compliance and risk management across all functions to ensure product efficacy and safety.

We provide innovative platforms for antibody discovery and development, including WuXiBody, WuXiHybrid, SDARBody, SKYBody, and VAST-B, enabling rapid and flexible biologic development.

Our advanced bioprocessing platforms, including continuous and intensified fed-batch technologies, deliver high yields and cost efficiencies.

We also offer custom protein generation, high-concentration formulation, and robust biomanufacturing solutions, supporting the full spectrum from research to commercial production.

Job Title - Executive Director, CMC Management

WuXi BiologicsUnited States (Remote)

Summary:

Leads project progression from proposal to completion, collaborating with clients and internal teams, and participates in business development activities such as client visits and conference representation.

Responsibilities:

• Provide technical and portfolio leadership for IND and BLA CMC activities.
• Coordinate with CMC functions to ensure project success, on time and within budget.
• Offer strategic and technical guidance for product development and manufacturing strategies.
• Lead projects, addressing technical challenges and regulatory compliance.
• Facilitate communication and alignment with clients.
• Ensure high-quality service, IP protection, and EHS compliance.
• Support business development efforts to expand service offerings and acquire new clients.

Qualifications:

• PhD in relevant fields (Biochemistry, Molecular Biology, Engineering).
• Experience in pharma/biotech industry, especially in cell line development, process development, analytical sciences, or GMP manufacturing.
• 10-20 years of relevant experience, depending on the level.
• Strong understanding of large molecule drug development, regulations, and industry trends.
• Biologics manufacturing experience required.
• Excellent communication skills in English and Chinese.
• Strong project management, problem-solving, and interpersonal skills.
• Experience in regulatory document writing and managing multiple projects.
• Self-motivated, flexible, organized, and detail-oriented, with about 10-15% travel.

The job description does not list all duties; additional responsibilities may be assigned based on expertise and business needs.

We are an Equal Opportunity Employer, considering all qualified applicants without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.