Director Biotherapeutics RD

Johnson & Johnson seeks a Director Biotherapeutics RD in Schaffhausen, CH, to lead the Analytical Development department within Proteins Development, focusing on drug product and combination product characterization. The role requires a PhD in Analytical Chemistry or related field, 10+ years in biopharmaceutical analytical development, and expertise in regulatory compliance and GMP standards.

This role is part of the Proteins Development organization and leads the Analytical Development department, focusing on drug product and combination product characterization. It directly supports the DPDS TDS Proteins Development Value Stream business objectives.

Responsibilities

• Lead the Analytical Development department, overseeing drug product assay development, qualification, validation, transfer, and analytical support for combination products, investigations, complaints, and Pilot Plant activities.
• Ensure adherence to top scientific, technical, EHS, and GMP standards across all operations.
• Drive timely and efficient development of new products while maintaining high quality standards.
• Provide strategic and scientific leadership in analytical development, including serving as the expert for large molecule drug product and combination product testing, method development, validation, and specification setting.
• Support creation and review of technical reports and regulatory submissions, contributing to compliance with international regulatory standards.
• Engage in industry and regulatory forums to influence regulatory strategies.
• Offer scientific guidance on complex manufacturing investigations, focusing on analytical aspects.
• Lead discussions to identify new scientific and technical opportunities for the large molecule product platform and advocate for their adoption through scientific leadership.
• Promote a learning environment and scientific excellence through training, mentorship, and leading by example.
• Mentor team members and cultivate a culture of excellence and inclusion.

Requirements

• PhD in Analytical Chemistry, Biochemistry, or a related scientific field.
• Minimum of 10 years of experience in biopharmaceutical analytical development, with emphasis on drug product and devices.
• Proven expertise in method development, validation, and lifecycle management.
• Demonstrated knowledge of analytical requirements for combination products.
• Experience with regulatory submissions and interactions.
• Proven ability to lead complex teams and manage cross-functional stakeholders.
• Strong understanding of GMP, EHS, and regulatory expectations.

Nice to have

• Experience with automation, digitalization, and advanced analytical platforms.
• Background in supporting novel therapeutic modalities.
• Track record of influencing regulatory or industry standards.

About the company

Johnson & Johnson fosters an inclusive work environment where each individual is valued. The company respects employee diversity and dignity, recognizes merit, and operates according to its Credo, committed to healthcare innovation and patient-centric science.

• Inclusive work environment where each person is valued as an individual.
• Respect for employee diversity and dignity.
• Recognition of individual merit.
• Guided by the company’s Credo.
• Commitment to healthcare innovation and patient-centric science.