CMC Director

WuXi Biologics
Manchester
8 months ago
Applications closed

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CMC Regulatory Consultant - Permanent

Regulatory CMC Consultant

Senior Project Manager, R&D: Drug Development

Summary:

Oversight of projects from the proposal stage through project completion by interacting with the client, technical team, and business development team. The position will also participate in business development activities such as visiting 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
  • 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:

  • Advanced degree (Ph.D. or MSc.) in Biochemistry, Molecular Biology, Biochemical/Chemical Engineering or related discipline.
  • Depending upon the titles, a minimum of 5-15 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 current regulations and industry trends for large molecules including but not limited to bispecific antibody and antibody drug conjugates.
  • Ability to effectively work in a matrix organization across functions and sites. Ability to plan & prioritize and handle multiple CMC projects at a time.
  • Excellent verbal and written communication skills in English. Basic knowledge in Chinese is preferred.
  • Strategic view and leadership abilities as well as hands on problem solving skills. Experience in project management is required.
  • Must be a self-starter, self-motivated, and highly flexible in this home based position with about 10%-15% travel. Must be organized and detail-oriented.


Opportunities:

  • Broaden knowledge and experience in the field of biopharmaceutical industry from drug discovery, development and commercialization
  • Develop and enhance leadership skills in people and project management
  • Strengthen interpersonal and communication skills
  • Build up business acumen and network collaboration

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