Director Biotherapeutics RD

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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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 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

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Preferred Skills: