Jobid=622414400207790990 (0.044)
About the Role 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. 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 the same fields 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 #J-18808-Ljbffr
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