Senior Director, CMC

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

Job summary

A leading company in biologics is seeking an Executive Director for CMC Management. The role involves leading project progression, collaborating across functions, and ensuring timely execution of CMC activities. Candidates should have extensive experience in biologics and strong project management skills.

Qualifications

• 8-20 years in relevant industry areas, depending on title.
• Strong understanding of biologics and large molecule drug development.

Responsibilities

• Lead CMC projects, addressing technical challenges and regulatory compliance.
• Provide technical and portfolio leadership for IND and BLA CMC activities.

Skills

Communication

Project Management

Problem Solving

Education

PhD in relevant disciplines

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 and industry-leading timelines for cell line engineering and strain development, as part of our CMC development platforms.

Our analytical testing services include method development for in-process, release, and stability assays, supporting cell line, process, and formulation development, product characterization, and other IND- and BLA-enabling studies.

Multiple upstream and downstream labs facilitate fed-batch, intensified fed-batch, and continuous manufacturing approaches for diverse biotherapeutics, in early and late-stage development.

Late-Stage Development and Process Characterization services ensure GMP manufacturing and support rapid BLA filing.

We provide drug product development spanning biologics, vaccines, and small molecules, including formulation in various forms and container systems.

Our in-house, GMP-compliant cell banking and characterization services operate over 20 cGMP suites, ensuring capacity and timely execution.

Our laboratories are EMA, ISO (CNAS), and CMA-certified, with a proven track record for viral clearance studies accepted by global regulators.

Our regulatory team supports drug filings with extensive experience since 2015, including over 370 INDs/CTAs and 200+ Module 3 CMC packages.

We operate multiple GMP facilities for biologics drug substance and drug product manufacturing worldwide.

Our biosafety testing facilities and viral clearance capabilities support raw materials, cell lines, and bulk testing.

We offer assay development, forensic investigation, and other characterization services tailored to your product needs.

Our Centers of Excellence support testing throughout the product lifecycle, expediting timelines and ensuring readiness.

Our QC labs support GMP sites with testing, environmental monitoring, validations, and audits.

Our global quality systems meet regulatory standards, with a strong commitment to quality and compliance across all sites.

Our regulatory team has supported over 550 INDs/CTAs and 200+ Module 3 CMC packages since 2015.

We provide rapid development platforms for antibodies and biologics, with a 10-month DNA to IND timeline and streamlined late-phase services for BLA filing within 15 months.

WuXiBody platform enables bispecific and multispecific antibody development, reducing timelines by 6-18 months.

Our hybridoma, phage display, VHH, and multispecific platforms support diverse antibody discovery and development.

Our high-yield cell line development and continuous bioprocessing platforms aim to maximize productivity and reduce costs.

We offer high-concentration formulation platforms to develop stable, low-viscosity biologics.

Our large-scale manufacturing facilities and advanced fill/finish systems support clinical and commercial supply.

Our single-source solutions support animal health from research to manufacturing.

Job Title - Executive Director, CMC Management

WuXi Biologics United States (Remote)

Summary:

Leads project progression from proposal to completion, interacting with clients, technical, and business teams, and participates in business development activities.

Responsibilities:

• Provide technical and portfolio leadership for IND and BLA CMC activities.
• Collaborate across CMC functions to ensure timely, within-budget project execution.
• Offer strategic and technical guidance for product development and manufacturing strategies.
• Lead CMC projects, addressing technical challenges and regulatory compliance.
• Serve as decision-maker for technical issues and coordinate communications.
• Support team to deliver high-quality, compliant services.
• Assist in business development and client engagement.

Qualifications:

• PhD in relevant disciplines (Biochemistry, Molecular Biology, Engineering).
• Experience at large pharma or biotech companies.
• 8-20 years in relevant industry areas, depending on title.
• Strong understanding of biologics and large molecule drug development.
• Knowledge of current regulations and trends for biologics and ADCs.
• Biologics manufacturing experience.
• Excellent communication skills in English and Chinese.
• Strong project management, problem-solving, and interpersonal skills.
• Experience with regulatory documents and multiple CMC projects.
• Preferred experience with CROs or CMOs.
• Self-motivated, flexible, organized, and detail-oriented, with about 10-15% travel.

Note: The role may include other duties based on expertise and business needs. We are an Equal Opportunity Employer, considering all qualified applicants without discrimination based on race, color, religion, sex, or other protected categories.