Principal Scientist, AD Scientific Integrator

Johnson Johnson; Leiden; On-site; EUR 90,000 - 130,000; Full time

Job summary

The Leiden Protein Analytical Development team, part of the Discovery, Product Development and Supply (DPDS) organization at Johnson & Johnson, is recruiting a Principal Scientist to assume the role of Analytical Scientific Integrator in Leiden.

You will lead global analytical development activities, contribute to regulatory submissions, and guide a cross-functional team to deliver robust analytical strategies in biotherapeutic development, shaping content for lifecycle management and regulatory

Responsibilities

• Lead analytical development activities across clinical development and/or life cycle management, including but not limited to CMC development, method replacements, comparability studies, shelf life extensions and specification management.

Job description

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

Scientific/Technology

All Job Posting Locations:

Leiden, South Holland, Netherlands

Job 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 .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

The Leiden-based Protein Analytical Development team, part of the Discovery, Product Development and Supply (DPDS) organization in Johnson & Johnson, is recruiting for a Principal Scientist to take on the role of Analytical Scientific Integrator.

The Leiden Protein analytical development team is responsible for a wide range of activities to help the development and commercial manufacturing of our protein products. Our focus ranges from method development, comparability studies, protein characterization, complex investigations, life cycle management to the activities needed to make those a reality, such as technical innovation, lab operations, regulatory filings, automation and advanced data analytics.

Science and innovation are at the heart of what we do, realized by close teamwork based on mutual respect and passion for delivering for our patients. We are a highly diverse team, with over 10 nationalities from different backgrounds, operating in an international environment. Working in the Leiden AD team offers the opportunity to learn firsthand what it takes to bring our products to the patient across product development and commercialization.

As scientific integrator you will play a critical role in our team and be responsible for all global analytical development activities. This means you will lead local and global cross functional teams, and participate in CMC and/or Value Stream teams to deliver the program's analytical development needs. The role is highly dynamic with priorities changing frequently, and highly visible given both the criticality of the role and the wide range of stakeholders and teams you will need to work with globally. The role therefore offers the opportunity to deploy and further develop your leadership, strategic, and scientific skills in biotherapeutic analytical development.

Core Responsibilities

• Lead analytical development activities across clinical development and/or life cycle management, including but not limited to, CMC development, method replacements, comparability studies, shelf life extensions and specification management.
• Accountable for analytical content in global regulatory submission, post approval submissions, and health authority interactions, including audits.
• Represent AD on the CMC and VC team and be accountable for all analytical deliverables.
• Define and drive analytical strategies aligned with product phase and regulatory expectations, and lead a cross-functional scientific team consisting of members from each of the AD sub-functions.
• Effectively communicate project status/overview, resources, budget, risks, and mitigation strategies to senior management.
• Interact with and influence v