Senior Scientist - Scientific Integrator Pharmaceutical Product Development & Supply

Jnj (Antwerp, België) 8 dagen geleden gepost
"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo Senior Scientist - Scientific Integrator Pharmaceutical Product Development & Supply Position overview Janssen Research & Development area develops treatments that improve the health and lifestyles of people worldwide. R&D development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, pulmonary hypertension and reproductive medicine. At Janssen R&D within the Pharmaceutical Product Development & Supply (PPDS) organization we are recruiting a Senior Scientist Scientific Integration, based in the greater area of Antwerp, Belgium. The Scientific Integrator is the PPDS representative and single point of contact on the CMC (Chemistry Manufacturing & Controls) new product development teams. The Scientific Integrator leads a sub team of PPDS scientists including Oral Solid Dosage Development, Parenterals & Liquids, Pharmaceutical and Material Sciences, Primary Container & Device, integrating PPDS activities so that deliverables are being met balancing cost/time/quality. Specifically, the Scientific Integrator (SI) will provide strategic and scientific technical leadership, ensuring the focus on scientific excellence is maintained within the PPDS/CMC teams.. Driving the project advancement in partnership with PPDS functions, CMC lead, CDT functions (preclinical and clinical) and the commercial organization while ensuring scientific standards are met Delivering clinical and commercial robust formulations and manufacturing processes, meeting manufacturing performance, cost needs, in line with QbD principles Representing PPDS as core member of the CMC team, with key interactions with API and analytical integrators, supply chain, Quality Assurance, CMC Regulatory Affairs and external consultants and vendors. Co-leading the BioPharm team, composed of CMC functions, clinical, preclinical, regulatory, non-clinical safety and/or other relevant functions to ensure correct formulation selection in view of the required PK profile, to determine bridging strategies, to define clinically relevant controls and ultimately accurate specifications. Responsible to have a full product and process technical/scientific understanding. Responsible for and driving the Governance Review for the assigned projects. Managing the DP risk register and defining mitigation plans and ensuring rapid identification and resolution of problems. Qualifications You have a Master’s Degree or PhD in Chemistry, Pharmacy, Biochemical Engineering, Chemical Engineering or a related field with more than three (3+) years of experience or the equivalent training/experience You have competencies and experience in Drug Product development within the pharmaceutical industry. You demonstrate a high level of technical understanding. You have experience in scale up of manufacturing processes and technical transfer of projects into commercial manufacturing. Drug Product development experience that has a span early through late is helpful. You can demonstrate leadership in providing integration of activities and delivering information across multifunctional groups and sites. You have excellent interpersonal skills with the ability to adapt effectively to rapidly changing project strategies You can make difficult decisions in a timely fashion along with excellent follow through and organizational skills to assure team and organizational alignment You can influence partners without line authority You have excellent communication skills, oral and written, as well as conflict management and negotiation skills This position is based in Beerse, Belgium and may require up to 15% international and domestic travel. 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 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. Primary Location Belgium-Antwerp-Antwerp- Organization Janssen Pharmaceutica N.V. (7555) Job Function R&D Requisition ID 2105963263W

Senior Scientist - Scientific Integrator Pharmaceutical Product Development & Supply

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