Christian Braun
Rielasingen-Worblingen
Summary
Seasoned development executive with over 25 years in biopharmaceutical development, demonstrating strong leadership in analytical strategy, regulatory filings, and global operations. Proven success in delivering IND, BLA, and ROW submissions, facilitating product launches and lifecycle management for complex protein therapeutics, including monoclonal antibodies and combination products. Expertise in building and scaling cross-site analytical organizations fosters scientific innovation, digital transformation, and phase-appropriate quality to support global commercial portfolios and substantial R&D pipelines. Dedicated to advancing the biopharmaceutical landscape through strategic insights and operational excellence.
Overview
32
32
years of professional experience
1
1
Certification
Work History
Senior Director DPDS TDS BTDS-AD, Head Analytical Development Europe
Janssen Research & Development / Janssen Supply Chain
10.2023 - Current
- Set analytical strategy and execution across Ireland, Netherlands, and Switzerland; managed direct and indirect teams supporting protein therapeutic development and commercial product support.
- Oversaw clinical release, stability programs, device development, method development, validation, transfers, and investigations.
- Prepared analytical content for regulatory submissions and engaged with health authorities and inspectors.
- Coached and developed scientific leaders; optimized resource allocation across critical programs to reduce timelines and costs.
- Interim Global AD Leader since Aug 2025
Director DPDS TDS BTDS-AD, Department Head
Janssen R&D
05.2019 - 09.2023
- Led drug product assay development, qualification, validation and transfer for large-molecule programs and combination products.
- Provided E2E scientific direction for analytical development and supported regulatory strategy and submissions (IND, BLA, ROW).
- Championed innovation, including automation and advanced analytical technologies, and represented the organization in industry and regulatory forums.
Director Value Chain Management
Janssen SC
10.2017 - 04.2019
- End-to-end product stewardship for STELARA; led LCM portfolio prioritization, sourcing, and cross-functional governance to ensure product quality and supply reliability.
Technical Operations Fellow; Principal Scientist; Senior Scientist; QC/QA Roles
01.1994 - 01.2017
- Held progressive technical and leadership roles spanning technical transfer, launch support, QC/QA leadership, and establishment of new analytical capabilities.
- Led technical teams supporting major launches (e.g., Daratumumab, Darzalex, Remicade) and implemented process improvements that reduced cycle times and costs.
Education
Dipl.-Ing. (FH) - Pharmaceutical Chemistry
Academy of Science and Technology
Isny, Germany01.1994
Skills
- Analytical Development Strategy, Method Development, Validation & Transfer
- Regulatory Submissions; IND, BLA, MAA, ROW filings and health authority interactions
- Global Team Leadership; cross-site matrix management, talent development, change management
- Protein Therapeutics Expertise; large molecules, antibodies, combination products, device testing
- Quality and CMC Strategy; phase-appropriate quality, investigations, GMP interfaces
- Operational Excellence & Digital Innovation; lab automation, robotics, cost/time optimization
- Stakeholder Management; TA, RA, Quality, Supply Chain, CMOs, CROs, global health authorities
- Collaborative leadership
- Culture transformation
- Strategic Thinking
- Stakeholder Management
- Operational Excellence
- Pharmacovigilance
Accomplishments
- Led implementation of short- and long-term analytical strategies across multiple European sites, aligning ~150 scientists and ~100 contractors to support protein therapeutic development and global lifecycle activities.
- Accountable for analytical contributions to IND and BLA submissions and for preparing Analytical sections for ROW filings; participated in regulatory meetings and inspections.
- Drove automation and robotics implementation for end-to-end drug product/device analytical workflows, improving throughput and reproducibility.
- Directed cross-functional initiatives to reduce drug product COGs and accelerate technical transfers, including dual-sourcing strategies for commercial launches.
- Established the first Janssen combination product testing laboratory as a Center of Excellence, introducing novel non-destructive and 3D measurement technologies.
- Recognized with multiple internal awards for leadership and technical innovation supporting product launches and lifecycle management.
Certification
Leaders Developing Leaders; FPX Coach / SME; FPX Project Leader; Certified Supplier Auditor (Germany)
Additional Information
Patents & Awards
Patent Applications: Controlled release preparations comprising Tramadol and Topiramate; Sustained release formulation of Tramadol.
Awards: Standard of Leadership Award (Darzalex); Innovation Leadership Award; Vice President’s Research Award for Outstanding Technical Achievement.
Certifications: Leaders Developing Leaders; FPX Coach / SME; FPX Project Leader; Certified Supplier Auditor (Germany)
Timeline
Senior Director DPDS TDS BTDS-AD, Head Analytical Development Europe
Janssen Research & Development / Janssen Supply Chain
10.2023 - Current
Director DPDS TDS BTDS-AD, Department Head
Janssen R&D
05.2019 - 09.2023
Director Value Chain Management
Janssen SC
10.2017 - 04.2019
Technical Operations Fellow; Principal Scientist; Senior Scientist; QC/QA Roles
01.1994 - 01.2017
Dipl.-Ing. (FH) - Pharmaceutical Chemistry
Academy of Science and Technology
Patents & Awards
Patent Applications: Controlled release preparations comprising Tramadol and Topiramate; Sustained release formulation of Tramadol., Awards: Standard of Leadership Award (Darzalex); Innovation Leadership Award; Vice President’s Research Award for Outstanding Technical Achievement.
Leadership Profile & Global Experience
- People Leadership: 15+ years managing multi-disciplinary teams; experienced in mentoring senior and junior scientists and building inclusive cultures.
- Global Operations: Cross-site leadership and collaboration with TA, TD, PSTS, IMSC, RA, QA, CMOs and CROs across Europe and global sites.
- Regulatory & Quality Interface: Direct experience preparing analytical sections for global filings, supporting inspections, and shaping phase-appropriate quality strategies.