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**Job Function: **
Discovery & Pre-Clinical/Clinical Development
**Job Sub Function: **
Biotherapeutics R&D
Job Category:
People Leader
All Job Posting Locations:
Schaffhausen, Switzerland
Job 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