Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Biotherapeutics R&DJob Category:
People LeaderAll Job Posting Locations:
Schaffhausen, SwitzerlandJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for Director Biotherapeutics RD to be in Schaffhausen
Purpose:
The Department Head, Analytical Development – Proteins (Drug Product & Device Characterization) leads a critical function within the Proteins Development organization, driving scientific excellence, innovation, and operational performance across drug product analytical development and combination product support.
You will be responsible for:
Managing an Analytical Development department with focus on Drug Product assay development/qualification/validation/transfer, analytical support for Combination Products, investigations, and complaints, as well as Pilot Plant support.
Ensure best scientific, technical EHS and GMP standards.
Ensure efficient and successful development of new products in a timely manner while maintaining high standards of quality.
Provide strategic and scientific direction in analytical development areas, in particular serve as the large molecule analytical development expert on drug product, combination product testing, test method development and validation and establishment of specifications.
Support the preparation of technical reports, regulatory submissions, participate in their review, and contribute to development of strategies to comply with international regulatory standards.
Participate in industry and Regulatory forums to shape Regulator strategies.
Provide scientific guidance on complex drug product manufacturing investigations with focus on analytical aspects
Lead discussions to identify new scientific/technical opportunities for the large molecule product platform, and negotiate/ influences acceptance of new opportunities and concepts through scientific leadership
Support a learning environment and foster a culture of scientific excellence through training, influence and leading by example
Act as a senior internal expert with a direct impact on DPDS TDS Proteins Development Value Stream business objectives.
Mentor team members and foster a culture of excellence and inclusion.
Qualifications / Requirements:
Required
PhD in Analytical Chemistry, Biochemistry, or related scientific discipline
10+ years of experience in biopharmaceutical analytical development, with strong focus on drug product and devices
Demonstrated expertise in:
Method development, validation, and lifecycle management
Combination product analytical requirements
Regulatory submissions and interactions
Proven leadership experience managing complex teams and cross-functional stakeholders
Strong knowledge of GMP, EHS, and regulatory expectations
Preferred
Experience with automation, digitalization, and advanced analytical platforms
Experience supporting novel therapeutic modalities
Track record influencing regulatory or industry standards
Required Skills
Strategic Thinking
Scientific Leadership
Stakeholder Management
Analytical Development Expertise (CMC)
Regulatory Knowledge
Decision Making & Problem Solving
Developing Others & Inclusive Leadership
Operational Excellence
Key Working Relationships
Internal:
TA, DPDS, API, DPD&D, CSC, CMC Teams, Quality Assurance, Regulatory Affairs, Supply Chain, Manufacturing & QC
External:
Health Authorities, Industry Forums, Contract Organizations (CROs/CDMOs), Scientific Networks
Required Skills:
Preferred Skills:
Analytical Reasoning, Biochemistry, Business Savvy, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Compliance Management, Developing Others, Drug Discovery Development, Inclusive Leadership, Leadership, Molecular Diagnostics, Operational Excellence, Pharmacovigilance, Process Improvements, Productivity Planning, Product Strategies, Program Management, Scientific Research, Stakeholder Management