Remote Senior Director, CMC Strategy & Project Leadership

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

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