Location
Leiden, South Holland, Netherlands; Ringaskiddy, Cork, Ireland; Schaffhausen, Switzerland
Role Overview
The Leiden-based Protein Analytical Development team, part of the Discovery, Product Development and Supply (DPDS) organization, is recruiting for a Principal Scientist to serve as an Analytical Scientific Integrator. In this role you will be responsible for all global analytical development activities, leading local and global cross‑functional teams, and participating in CMC and/or Value Stream teams to deliver the program’s analytical development needs.
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, 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 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. 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.
Strong leadership, influencing, communication (English, oral and written), interpersonal, and negotiation skills, and ability 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, organising, pharmacovigilance, presentation design, process improvements, productivity planning, scientific research.
Benefits
In addition to base pay, the role offers an annual bonus with set target based on pay grade/location, vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, programs for financial, physical and mental health, service anniversary and recognition awards, and eligibility for several insurance plans depending on location. For detailed information on benefits, visit the company’s employee benefits portal.
Salary
68,800 – 110,000 EUR Annual Gross (primary location); additional locations may vary.
EEO Statement
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, and disability.
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