WuXi Biologics · 15 hours ago
Senior Director, CMC
United States
Full-time
Remote
Director/Executive
$150K/yr - $280K/yr
8+ years expWuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions. The role involves leading CMC projects, collaborating with various teams, and participating in business development to promote services and enhance client relationships.
BiotechnologyHealth CareManufacturingPharmaceutical
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
Serve as the center of solution and decision maker for technical issues
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
Qualification
Required
PhD in Biochemistry, Molecular Biology, Biochemical/Chemical Engineering or related discipline
Technical experience at large pharma or biotech companies
Depending upon the titles, a minimum of 8-20 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 the pharmaceutical industry and large molecule drug development
Working knowledge and understanding of current regulations and industry trends for large molecule and Antibody-Drug Conjugate (ADC) product development, manufacture, and testing
Biologics manufacturing experience
Ability to effectively work across all levels, functions, sites, and companies. Excellent verbal and written communication skills in both English and Chinese
Candidate should possess strong and effective project management, problem solving and interpersonal skills and have a proven track record working cross-functionally across a wide variety of technical, business and operational areas
Experience in writing regulatory documents and submissions and the ability to work on multiple CMC projects at a time
Must be a self-starter, self-motivated, and highly flexible in this homebased position with about 10%-15% travel
Must be organized and detail-oriented
Preferred
Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred but not required
Company
WuXi Biologics
WuXi Biologics is a open-access technology platform company offering end-to-end solutions to empower organizations to discover and develop.
10001+ employees
H1B Sponsorship
WuXi Biologics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (23)
2024 (32)
2023 (22)
2022 (12)
2021 (17)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown2017-06-13IPO
2017-01-01Series Unknown
Leadership Team
Jijie Gu, Ph.D.
Executive Vice President & Chief Scientific Officer & Global Head BD&L
Adrienne Johnson, SPHR
Sr. Human Resources Business Partner
Recent News
South China Morning Post
2026-01-23
South China Morning Post
2026-01-19
Company data provided by crunchbase