Senior Principal Scientist/Principal Scientist - Scientific Integration, Analytical Development

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Pharmaceutical Product R&D Job Category: Scientific/Technology All Job Posting Locations: Beerse, Antwerp, Belgium Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine The Global Analytical Development (AD) organization, part of the Discovery, Product Development and Supply (DPDS) division of Johnson & Johnson Innovative Medicine (JJIM), is dedicated to developing advanced analytical development solutions to advance our Synthetic Modalities portfolio (small molecules, oligonucleotides, peptides, conjugates, etc.). Our development hubs span the US, Asia, and Europe, and comprise a network of vibrant teams including over 270 dedicated analytical professionals. We are searching for a Senior Principal Scientist/Principal Scientist - Scientific Integration, based at our R&D facility in Beerse (greater area of Antwerp), Belgium. Role Purpose As the Scientific Integrator, represent Analytical Development as the single point of contact on CMC (Chemistry, Manufacturing & Controls) new product development teams, acting as a leading scientific expert and individual contributor who independently owns and drives portfolio projects that directly impact R&D business results. Provide scientific and strategic leadership for the analytical project strategy by translating product and CMC needs into executable deliverables, ensuring scientific rigor, regulatory readiness, quality, timelines and budgets across the product lifecycle, from preclinical development through marketed brand support. In this role, you will drive significant impact through Developing and maintaining integrated, fit-for-purpose analytical development and control strategies across the full product lifecycle, from feasibility through commercialization. Defining phase-appropriate analytical approaches for evolving product, platform and CMC needs, including method, characterization, specification, stability, technical transfer, regulatory strategy and budget planning for complex and emerging modalities. Providing strategic and scientific leadership across AD, CMC teams, sites and external partners, ensuring executable analytical deliverables, scientific rigor, regulatory readiness and risk-based decision-making. Leading and integrating multidisciplinary Analytical Development activities across method development/validation, clinical release and stability, characterization, dissolution sciences, pharmaceutical and material sciences within a matrix organization. Overseeing project execution and accelerating decisions, balancing cost, time and quality while resolving complex analytical challenges through stakeholder alignment, proactive collaboration, issue escalation and crisis coordination. Protecting patient and product quality while influencing broader portfolio and departmental strategy, applying current guidelines, SOPs, cGMP and regulatory requirements, and contributing to due diligence, cross-functional initiatives and continuous improvement. You will be responsible for Owning and managing the Analytical Development project strategy, translating project and CMC needs into functional tasks, deliverables, resources, timelines, budgets and governance activities. Representing Analytical Development as a core CMC team member, acting as the primary AD contact and scientific leader for API, drug product, supply chain, Quality Assurance, CMC Regulatory Affairs, external consultants and development partners. Leading and connecting analytical development product teams across functions, ensuring effective collaboration with development, quality, regulatory and supply-chain partners. Maintaining deep product and analytical understanding, ensuring analytical deliverables are scientifically robust and aligned with functional strategic technical platforms, including dossier content, Health Authority responses, inspections and customer audits. Leveraging digital, AI-enabled and modelling approaches, where appropriate, to strengthen analytical strategy, enhance scientific understanding, support risk-based decision-making and improve development efficiency. Leading drug substance and drug product specification setting, justification and lifecycle management, including retest period and shelf-life assignments. Identifying, escalating and resolving analytical risks and issues, generating practical, scientifically sound options to accelerate programs and coordinating analytical strategy during crisis-management situations. Applying current guidelines, SOPs, cGMP and risk-based principles to ensure quality, compliance, effective change-control management and protection of patient and product quality. Driving broader organizational impact through due diligence support, process improvement, stakeholder engagement, cross-departmental opportunities, mentoring, coaching and scientific consultation. Qualifications and experienceA minimum of a master's degree in chemistry, pharmacy or an equivalent scientific discipline, with excellent knowledge of analytics, method development, stability and specifications. An advanced scientific degree, such as a PhD, is preferred. A minimum of 8 years pharmaceutical industry experience with strong demonstrated scientific acumen. Demonstrated experience supporting one or more synthetic modality platforms (small molecules, oligonucleotides, peptides, conjugates or related technologies). Strong analytical scientific and project-management capability, with an inquisitive mindset and the ability to independently address complex issues and manage multiple priorities and commitments. Comprehensive knowledge of global regulatory requirements and guidelines applicable to synthetic pharmaceuticals, including application of cGMP requirements and relevant FDA, ICH and international guidance. Experience leading cross-functional project teams and influencing team members, partners and senior management in a highly matrixed organization. Strong leadership, communication, collaboration, negotiation, coaching, problem-solving and networking capabilities, with the ability to think strategically and influence across a matrixed organization. Demonstrated customer focus, results orientation, sound judgement, and the ability to balance workload and priorities. Fluency in written and spoken English is essential; Dutch is an advantage. What success looks likeClear, integrated analytical strategies that enable timely and high-quality CMC and commercial decisions. Robust analytical control strategies, specifications and dossier content supported by appropriate scientific understanding. Early identification and effective resolution of analytical risks, issues and change-control impacts. Committed cross-functional teams