Within Janssen R&D, a member of Johnson & Johnson's Family of Companies, we are recruiting a Principal Scientist - Drug Product Development Scientific Integrator, based in Beerse, Belgium.
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. The Principal Scientist Scientific Integrator is the DPD (Drug Product Development) representative and single point of contact on the CMC (Chemistry Manufacturing & Controls) new product development teams.
The Principal Scientist leads a sub team of DPD scientists including Oral Solid Dosage Development, Parenterals & Liquids, Pharmaceutical and Material Sciences, Primary Container & Device, integrating DPD 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 DPD/CMC teams.
Main responsibilities include:
• This role will be focused on defining the Drug Product development strategy across all clinical phases including Life Cycle Management, through in depth understanding of the compound properties and TPP (Target Product Profile), aligned with DPD function, CMC team and CDT (Compound Development Team) who sets the overall compound strategy.
• Driving the project advancement in partnership with DPD functions, CMC lead, preclinical and clinical functions, commercial functions 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
• The scientific integrator will overview the project as core member of the CMC team, and has key interactions with API and analytical integrators, supply chain, Quality Assurance, CMC Regulatory Affairs, preclinical, clinical, Non-Clinical Safety and external consultants and vendors.
• 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.
• You have a Masters Degree or PhD in Chemistry, Pharmacy, Biochemical Engineering, Chemical Engineering or a related field with five to ten (5 - 10) years of experience or the equivalent training/experience
• You have competencies and experience in DPD 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.
• DPD 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.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future! We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Janssen Pharmaceutica N.V. (7555)