UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing approximately 9 000 people in over 40 countries, UCB generated revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (symbol: UCB).
For our Pharma Manufacturing department, located in Braine-l’Alleud, we are looking for a
API Process Engineer
Ref: BRA 2338
The function:
Technical:
Support process development and optimisation of new and existing API commercial processes in terms of process engineering, quantity, quality, economy, GMP compliance, safety and environmental care. Design and process engineering for assigned products. Initiate and coordinate technology transfers to CMOs. Provide continuous technical support for assigned projects and products.
Managerial, Tactical:
Represent the DS manufacturing organization on project teams such as TSTs in development and lifecycle management. Make vs buy considerations. Define and implement sourcing strategy for assigned projects/products including in- and outsourced activities. Perform supply and CMO risk management and network management. Key technical contact for UCB sites as well as for CMOs for assigned products
Strategical:
Define long range plans and stategic sourcing for assigned projects and products.
Participate definition of site development plans.
Main Accountabilities
- Representation of DS Manufacturing organization interests and strategies for assigned products (e.g. via TSTs or LC) in an autonomus and integrated fashion
- Act as the link between the project team and the function in a crossfunctional manner
- Enable and support process development & industrilaization for assigned products by process engineering
- Enable and support regulatory filing of new API processes by providing appropriate technical documentation and CTD review
- Proactively identify, communicate and implement process optimization (in terms of quality, capacity, safety and costs) as appropriate
- Implement long range supply plans and strategies for the assigned products. Proactively update and revise as appropriate. Strategy needs to consider quality, safety, reliability, risk balance as well as economy
- Manage the technical part of the UCB CMO management approach for assigned products and CMOs
- Initiate and coordinate technology transfers to CMOs
- Participate Risk Management for products, CMOs and sites
The profile:
Education:
- Mater's degree in chemical process engineering.
Experiences:
- 6 years of industrial experience in pharmaceutical industry with a focus on DS development and industrialization. Experience in raw material, intermediates and API sourcing strategies.
Specific Skills:
- Solid knwoledge on API process engineering and process chemistry
- Regulatory filing of API processes
- Good quality, safety and GMP understanding
- Understanding on finance, focus CoGs
- Understanding of pharma development
- Skilled at writing and reviewing technical documentation
- Experience with project management tools (e.g. MS Project)
- Communication skills, team player, infuences, crossfunctional player
- Presentation, workshop and meeting facilitation skills
- Fluent in English
Offer:
We offer you an exciting job and challenges in an intermational company, career development opportunities and an attractive salary package with extralegal advantages.
More information about UCB : www.ucb.com
Interest
If you are interested in this position, please register on our website with the following link: https://ucb.taleo.net/careersection/10000/jobdetail.ftl?lang=en&job=BRA00002338
Your application will be treated in total confidentiality.