Senior Director, CMC

WuXi Biologics; United States; Remote; USD 161,000 - 274,000; Full time

Job summary

WuXi Biologics is seeking a Senior Director for the Mid-Atlantic CMC to lead complex Biologics CMC programs from the US, with remote work and ~10–15% travel. The role involves coordinating with client teams, technical groups, and business development to advance IND/BLA activities and regulatory submissions.

The successful candidate will guide product development and manufacturing strategy, ensure regulatory alignment, and balance timelines, budgets, and quality across multiple CMC projects while

Qualifications

• PhD in Biochemistry, Molecular Biology, Biochemical/Chemical Engineering or related discipline.
• 8–20 years of pharma/biotech experience.
• Strong English and Chinese written and oral communication.

Responsibilities

• Provide technical and portfolio leadership to support IND and BLA, enabling CMC activities.
• Collaborate with CMC functions to ensure timely, within-budget project delivery.
• Provide strategic guidance for product development and manufacturing strategy; lead CMC projects with regulatory alignment.

Skills

Project management

Cross-functional collaboration

Regulatory writing

Biologics manufacturing

CMC process knowledge

English/Chinese communication

Client leadership

Education

PhD in Biochemistry/Molecular Biology

Job description

Job Title – Senior Director, Mid-Atlantic CMC

Work Location - United States (Remote)

Summary

Opportunity for Senior Director through the Executive level, depending upon experience. Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting WuXi Biologic’s services at conferences/trade shows

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 solutions 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

Qualifications

• PhD in Biochemistry, Molecular Biology, Biochemical/Chemical Engineering or related discipline.
• Technical experience at large pharma or biotech companies. Depending upon the title, 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.
• Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred but not required. 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.

The pay range for this job opportunity ranges from $161,300 - $274,200

The job description does not intend to list all the duties and responsibilities assigned to this position. An employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and the company's business needs. The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.