Principal Scientist Biotherapeutics

Job Overview

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 team is responsible for a wide range of activities essential to the development and commercial manufacturing of protein products, ranging from method development and comparability studies to protein characterization and life cycle management.

Key Responsibilities

• Lead analytical development activities across clinical development and 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 teams and be accountable for all analytical deliverables.
• Define and drive analytical strategies aligned with product phase and regulatory expectations, leading a cross functional scientific team from all AD sub functions.
• Communicate project status, resources, budget, risks and mitigation strategies to senior management.
• Engage and influence stakeholders across DPDS, including Manufacturing, Regulatory, Quality and external partners.

Qualifications

• Minimum Master's degree in Analytical Chemistry, Biochemistry, Biological Science or a related discipline with at least 8 years of biopharmaceutical development experience. Ph.D. with at least 3 years of experience is preferred.
• Strong working knowledge of biotherapeutic development and 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 is preferred.
• Excellent leadership, influencing, communication (English, oral and written), interpersonal and negotiation skills; ability to collaborate in a matrix environment.

Preferred Skills

• Analytical reasoning, biochemistry, biotechnology, clinical research and regulations, clinical trial design, coaching, critical thinking, drug discovery development, emerging technologies, chemistry, CMC, molecular diagnostics, organizational skills, pharmacovigilance, presentation design, process improvement, productivity planning, scientific research.

Pay Range

68,800 - 110,000 EUR annual gross.

Benefits

Base pay plus annual bonus, vacation days, parental leave (minimum 12 weeks), bereavement leave, caregiver leave, volunteer leave, well being reimbursements, financial, physical and mental health programs, service anniversary awards, and access to several insurance plans. Detailed information is available from the Employee Benefits portal.

Equal Employment Opportunity

Johnson & Johnson is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status or disability.