Senior Principal Scientist Scientific Integration

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The Global Pharmaceutical Product Development and Supply (PPDS) organization part of the Discovery Product Development and Supply (DPDS) division of Johnson & Johnson Innovative Medicine (JJIM) is dedicated to developing advanced drug delivery solutions for 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 200 dedicated professionals.

We are searching for a Senior Principal Scientist - Scientific Integration based at our R&D facility in Beerse (greater area of Antwerp) Belgium.

Purpose:

Act as a leading expert within Pharmaceutical Product R&D and work independently to own major portions of Pharmaceutical Product R&D projects. Drive the delivery of Pharmaceutical Product R&D projects that have a direct effect on business results within R&D as individual contributor. As a scientific Integrator you will be a PPDS representative and single point of contact on the CMC (Chemistry Manufacturing & Controls) new product development teams.

In this role you will drive significant impact through:

• Providing strategic and scientific leadership to ensure a sustained commitment to scientific excellence within PPDS and CMC teams.

• Leading a multidisciplinary sub-team of PPDS scientistsincluding experts in Oral Solid Dosage and Parenterals and Liquids Pharmaceutical and Material Sciences clinical supply and process engineering and Primary Container & Device - within a matrix organizational structure.

• Integrating and overseeing PPDS activities to ensure all deliverables are achieved while effectively balancing cost time and quality considerations.

• Championing patient-centric product design to address unmet medical needs.

• Delivering scalable solutions by ensuring the development of robust manufacturable and launch-ready products suitable for global markets.

• Upholding the highest standards of quality and compliance by embedding Quality by Design principles and regulatory rigor throughout all stages of product development.

• Accelerating development timelines through proactive collaboration with CMC Quality Regulatory and Supply Chain partners to enable timely product launches and support lifecycle management success.

You will be responsible for:

• Establishing driving and executing comprehensive Drug Product development strategies across all clinical phases including Life Cycle Management with an unwavering focus on delivering patient-centric transformational therapies.

• Demonstrating expert-level understanding of compound properties and Target Product Profile (TPP) ensuring alignment among PPDS functions CMC teams and the Compound Development Team (CDT) which defines the overarching compound strategy.

• Driving project progression in collaboration with PPDS functions CMC leadership CDT functions (preclinical and clinical) and the commercial organization while upholding the highest scientific standards.

• Delivering robust clinical and commercial formulations and manufacturing processes that meet performance and cost requirements fully aligned with Quality by Design (QbD) principles.

• Serving as the primary representative for PPDS as a core member of the CMC team facilitating critical interactions with API and analytical integrators supply chain Quality Assurance CMC Regulatory Affairs and external consultants and vendors.

• Co-leading the BioPharm team comprising CMC functions clinical preclinical regulatory non-clinical safety and other relevant stakeholders to ensure proper formulation selection based on required pharmacokinetic (PK) profiles define bridging strategies establish clinically relevant controls and set accurate specifications.

• Assuming responsibility for comprehensive technical and scientific understanding of both product and process.

• Leading and overseeing Governance Reviews for assigned projects ensuring rigorous evaluation and oversight.

• Managing the Drug Product risk register developing and implementing mitigation plans and ensuring swift identification and resolution of issues.

• Pioneering innovative approaches to scientific and technical excellence designing robust processes that enable flawless execution and appropriate risk management.

• Serving as a key contributor to specific sections of regulatory filings demonstrating proficiency in CMC regulatory documentation.

• Leading and participating in continuous improvement initiatives to enhance process efficiency and exert cross-departmental influence to achieve organizational objectives.

• Providing guidance and mentorship to junior colleagues through expert consultation and instruction in relevant techniques processes and program strategies.

Qualifications & Experience

• Ph.D. or masters degree in Pharmaceutical Sciences Industrial Pharmacy Chemical/Biochemical Engineering or a related field with a minimum of 1015 years of relevant industry experience or equivalent training.

• Extensive expertise in Drug Product development within the pharmaceutical industry demonstrating a strong technical foundation and understanding.

• Proven experience in scaling up manufacturing processes and leading successful technology transfer of projects into commercial manufacturing environments.

• Comprehensive background in Drug Product development spanning from early-stage to late-stage activities.

• Demonstrated leadership in integrating activities and delivering results across multifunctional and cross functional teams and across multiple sites including CMOs/CDMOs.

• Exceptional interpersonal skills with the ability to adapt effectively to evolving project strategies.

• Skilled in making timely complex decisions coupled with strong organizational and follow-through capabilities to ensure team and organizational alignment.

• Ability to influence stakeholders and partners without direct line authority.

• Outstanding oral and written communication abilities including conflict management and negotiation skills.

• Proven record of leading complex development programs and delivering commercial products.

• In-depth understanding of regulatory requirements (ICH FDA EMA) and quality systems.

• Strategic thinker with excellent problem-solving collaboration and networking skills.

• Position based in Beerse Belgium with up to 15% domestic and international travel required.

Our offer:

• An exciting position in an international and dynamic environment with continuous learning and growth opportunities

• Working on a site that harbors all aspects of the drug discovery process located close to the vibrant city of Antwerp.

• A competitive salary on-site sport accommodations health/energy programs and other benefits for you and your family.

• An inclusive team environment where diversity and different opinions are respected and valued and the importance of a good work-life balance is recognized.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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 or protected veteran status and will not be discriminated against on the basis of disability.

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