CMC Director (Europe Based)

WuXi Biologics; Deutschland; Remote; EUR 140,000 - 190,000; Full time

Job summary

WuXi Biologics seeks a senior lead to oversee projects from proposal to completion, engaging clients, technical teams, and business development. The role is remote based in Europe with occasional travel, offering leadership in CMC activities and strategic direction for product development and manufacturing.

The candidate will drive IND/BLA support, ensure regulatory compliance, and coordinate with clients to expand WuXi Biologics’ service offerings while building a strong, high-performance team

Qualifications

• Advanced degree required (Ph.D. or MSc.) in Biochemistry, Molecular Biology, Biochemical/Chemical Engineering or related field.
• Must have 8–15 years in pharma/biotech industry with CMC/analytical/GMP exposure.
• Strong English verbal and written communication; Chinese a plus.

Responsibilities

• Provide technical and portfolio leadership to support IND and BLA enabling CMC activities.
• Collaborate with CMC functions to ensure successful execution of CMC projects within time and budget.
• Provide strategic thinking and technical guidance for project teams in product development and manufacturing strategy.
• Lead CMC projects understanding regulatory requirements and ICH guidelines.
• Coordinate efforts to align WuXi Biologics with clients through effective communication.
• Work with a high-performance team to ensure quality services, IP, and EHS compliance.
• Support corporate business development to enhance offerings and develop new clients.

Skills

Leadership

Project management

English communication

Client engagement

Matrix organization

Strategic thinking

Education

Ph.D. or MSc. in Biochemistry/Molecular Biology/Biochemical or Chemical Engineering

Job description

Lead the 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. This role will be remotely based in Europe.

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 of8-15 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. Chines is a plus.
• 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 homebased position with about 10%-15% travel. Must be organized and detail-oriented.
• 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