WuXi Biologics · 2 days ago
Director - Executive Director, CMC
United States
Full-time
Remote
Director/Executive
$150K/yr - $300K/yr
8+ years expWuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics. The Director - Executive Director, CMC will provide project leadership for IND enabling and late-stage product development CMC activities, ensuring successful execution of projects and alignment with regulatory requirements.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Provide project leadership supporting IND enabling and late-stage product development CMC activities
Participate and show leadership in establishing WuXi Biologics CMC strategies and recommendations in supporting all ongoing projects in CMC development
Lead CMC projects with a good understanding of potential technical challenges and meet the regulatory requirements and ICH’s quality and efficacy guidelines
Collaborate with CMC functional areas to ensure successful execution of various CMC projects and delivery of results on time and within budget
Chart the course, track progress against goals, and outline key strategic events for the project. Manage project scope definitions and changes, and budgets
Serve as the center of solution. Address any challenges and issues that arise. Make hard decisions
Engage efficiently with key stakeholders to ensure transparency on program status and alignment on program plans, goals, resource requirements, and timelines
Build a solid communication with clients to ensure alignment between WuXi Biologics and clients
Provide leadership in development and manufacturing alliance management, product development, and manufacturing strategy
Assist in recruiting, training, and retaining a high-performance CMC team to ensure the best quality service and leadership in CMC management functions worldwide
Support BD efforts and proposal writing team to enhance current service offerings and develop new clients
Develop and manage operational budgets and supervise teams to ensure IP and EHS compliance
Qualification
Required
Advanced degree (PhD or MS) in Bio/Chemistry, Bio/Chemical Engineering, Life Science, or related major with 8+ years of applicable work experience
Good knowledge of CMC strategy, risk and resource management, regulatory requirements, and ICH guidelines
Strategic view and leadership abilities as well as hands-on problem-solving skills. Experience in managing projects is required
Excitement about the vision and mission of WuXi Biologics
Preferred
Experience in two or more functional areas in Project Management, Cell Line Development, Cell Culture, Purification, Analytical, Formulation, Manufacturing, Manufacturing Support, QC or QA in the biologics industry
Experience with staff management and/or CMC team management
Ability to effectively work across all levels, functions, sites, and companies. Excellent verbal and written communication skills in both English and Chinese
Experience in writing regulatory documents and submissions and the ability to work on multiple CMC projects at a time
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
Morningstar.com
2025-12-24
Company data provided by crunchbase