Senior Director CMC

s
Company: Wuxi AppTec
Location: United States

Apply

Overview

WuXi Biologics, listed on Hong Kong Exchange, is a leading global biologics technology and enabling platform to discover, develop and manufacture biologics. 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 Biologic’s services in conferences/trade shows.

Responsibilities

  • Provide project and portfolio leadership supporting IND enabling early and late stage product development CMC activities.
  • Collaborate with CMC functional areas to ensure successful execution of various CMC projects, and delivery of results on time and within budget.
  • Assists with development and manufacturing alliance management, product development and manufacturing strategy
  • Coordinate efforts and facilitate communication to ensure alignment between WuXi Biologics and clients
  • Work with a high performance team to ensure best quality services
  • Enhance current service offering and develop new clients

Qualifications

Job Requirements:

Technical Skills / Knowledge:
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.
Demonstrates good understanding of the pharmaceutical industry and small molecule drug development.
Minimum of 10-15 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing.
Working knowledge and understanding of current regulations and industry trends for small molecule and Antibody-Drug Conjugate (ADC) product development, manufacture and testing.
Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required.

Must have working knowledge of MS Office products, especially MS Project.

Independence/Accountability:
Must be a self-starter, self-motivated, and highly flexible in this homebased position with ~10% travel.
Must be organized and detailed-oriented.

Problem Solving:
Proven experience in creating and carrying out successful plans and processes to solve complex problems.

Leadership Activities:
Work closely with team members across all CMC related business units and with the STA management team to ensure coordination of all efforts and real-time communication with all stakeholders.

Communication Skills:
Proficiency in both English and Mandarin is required.
Excellent communications skills (verbal, written, and presentation skills).

Customary Education and Experience:
PH D Chemistry or related discipline, MBA, Fluent in English and Mandarin Chinese.
Technical experience at large pharma.
Biologics manufacturing experience.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled