Job Title: Principal Scientist - Pharmaceutical Product Integrator
Posted: 2021-10-13 13:16:13
Posted: 2021-10-13 13:16:13
We are supporting a global pharmaceutical company bringing innovation and fundamental changes to the way diseases are managed, interpreted and prevented. We are recruiting for a Principal Scientist - Scientific Integrator to act as the representative for pharmaceutical product development and supply, and be the single point of contact on CMC new product development teams. We are looking for an individual with a solid scientific background and personal skills to be the face and voice of the team.
Tasks & Responsibilities:
· 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 PPDS functions, CMC team and CDT (Compound Development Team) who sets the overall compound strategy.
· 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
· Coaches other Scientific Integrators in their projects
· Leads and contributes to business/work process improvement initiatives
Qualifications & Experience:
· You have a Master’s 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 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.
· 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.
· Flexi- on site working