Global Analytical Development Lead – Biotherapeutics

Johnson & Johnson Innovative Medicine; Leiden; On-site; EUR 69,000 - 120,000; Full time

Job summary

The Leiden-based Protein Analytical Development team at Johnson & Johnson is seeking a Principal Scientist to act as Analytical Scientific Integrator, leading global analytical development activities and cross-functional collaborations in biotherapeutic development.

You will direct CMC-related efforts, engage in regulatory submissions, and drive strategies across product phases while mentoring a diverse, international team in a fast-paced environment.

Qualifications

• Master’s degree with at least 8 years in biopharmaceutical development.
• Ph.D. with at least 3 years in biopharmaceutical development preferred.
• Strong knowledge of analytical strategy including protein characterization, separation techniques, and potency assays.
• Experience authoring and reviewing IND and/or BLA/MAA sections and addressing health authority questions.
• Strong leadership, influencing, communication (English, oral and written), interpersonal, and negotiation skills; able to collaborate across teams in a matrix environment.

Responsibilities

• Lead analytical development activities across clinical development and/or life cycle management, including CMC development, method replacements, comparability studies, shelf life extensions and specification management.
• Accountable for analytical content in global regulatory submissions, 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.
• Effectively communicate project status, 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.

Skills

Leadership

Communication

Analytical thinking

Biotherapeutics knowledge

Education

Master’s degree

PhD in Analytical Chemistry/related

Job description

The Leiden-based Protein Analytical Development team at Johnson & Johnson is seeking a Principal Scientist to act as Analytical Scientific Integrator, leading global analytical development activities and cross-functional collaborations in biotherapeutic development.

You will direct CMC-related efforts, engage in regulatory submissions, and drive strategies across product phases while mentoring a diverse, international team in a fast-paced environment.