Principal Scientist Biotherapeutics

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 various stakeholders outside of DPDS including Manufacturing, Regulatory, Quality,and external partners.

QUALIFICATIONS

• A minimum of a Master’s degree in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline with at least 8 years of experience in biopharmaceutical development is required. A Ph.D. in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline with at least 3 years of experience in biopharmaceutical development is preferred.
• Working knowledge of biotherapeutic development and analytical strategy including analytical protein characterization, separation techniques, and biological potency assays is required.
• Experience authoring and reviewing IND and/or BLA/MAA sections and addressing health authority questions is preferred.
• Must have strong leadership, influencing, communication (English, oral and written), interpersonal, and negotiation skills and be able to collaborate across teams in a matrix environment.

Preferred Skills:

Analytical Reasoning, Biochemistry, Biotechnology, Clinical Research and Regulations, Clinical Trial Designs, Coaching, Critical Thinking, Drug Discovery Development, Emerging Technologies, Chemistry, Manufacturing, and Control (CMC), Molecular Diagnostics, Organizing, Pharmacovigilance, Presentation Design, Process Improvements, Productivity Planning, Scientific Research

Hybrid Wor