Principal Scientist Pharma Prod RD

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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:

There is already a pre-identified candidate for this position.

The Principal Scientist (ST7) Scientific Integrator leads a sub team of Drug Product research & Development (DPRD) scientists including Oral Solid Dosage Development, Parenterals & Liquids, Pharmaceutical and Material Sciences, Primary Container & Device, integrating DPRD 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 DPRD/CMC teams.

Tasks & Responsibilities:



* This role will be focused on implementing 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 PPDS functions, CMC team and CDT (Compound Development Team) who sets the overall compound strategy.


* Driving the project advancement in partnership with DPRD 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 DPRD 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 technic...