Senior Scientist

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Description:

Help us transform patients' lives.
At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?
For UCBs outstanding Biologics Molecule Pipeline, we search for a Senior Scientist. 

Biologics Drug Product Development Specialists supporting our late stage development/clinical projects, during the preparation for commercialization.

This includes:

Process Development:
Define and execute work packages related to development of the Drug Product presentations and manufacturing process, fit-for-purpose for clinical phases 1-3, and support filing preparations.

Project Management:
Building of the Drug Product (DP) strategic development plan.Conducting yearly resource forecasting based on defined work packages and assessing additional resource needs when project requirements change.Support the creation of the project budgets (CAPEX & OPEX) for the TST.Develop the 5 Year Project Plan for DP, in alignement with formulation- and packaging teams.Track all ongoing activities for the DPPDD team members on the project.

Matrix Team Management: 
Coordinate in a matrix environment a team of DP Subject Matter Experts (SMEs).Coordinate pre- and post- TST meetings with DP SMEs - ensuring that all relevant project information is collated and shared at the TST and providing feedback to DP SMEs from the TST.

Technical Documentation:
Accountable for CMC documentation (reports, FMEA, …) as either author or reviewer.

Communication:
Communication of DP strategy and status of plans to the TST.Communication of overall project strategy from the TST to SMES and DP - and Biotech Clinical Manufacturing Sciences (BCMS) Leadership Teams.Timely escalation of risks/issues/deviations related to the development plans to the project – and leadership team, as required.

Other:
Lead and/or contribute to failure investigations and impact assessments of DP manufacturing processes at clinical and commercial Fill & Finish Facilities (Internal and external).

Profile: 
Master's degree preferred. Minimum 10 years experience in drug product development for Biologics, and steriles manufacturing within the biopharmaceutical industry.An understanding of the issues and challenges of taking products from late stage development into commercialisation.Good knowledge and technical experience in parenteral liquid drug product development and cGMP manufacturing under aspetic conditions.Good technical knowledge of sterile DP development covering DP components, process transfer, scale and optimization.Knowledge in primary and secondary packaging.Knowledge of analytical, preformulation and formulation development is an asset.

Excellent communication skills.Team player.Strong ability to work autonomously and prioritize work packages as per project requirments. Capable to build strong networks with internal- and external stakeholders.Strive for process efficiency improvements, waste reductions and cost improvements.

About us.
UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.
With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.
Curious to know more? Please visit our website .
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

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