Head of Product Development
Date: Feb 10, 2019
Location: Braine L'alleud, Walloon Brabant, BE
Head of Product Development
Help us transform patients' lives.
At UCB, we put our heart, soul and skills into making a difference for people living with chronic diseases. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?
Headquartered in Brussels, Belgium, UCB is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. UCB operates in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016.
An opportunity has arisen for us to recruit a new Head of Product Development within our small molecules Pharmaceutical Sciences Department.
To strengthen our Pharmaceutical Sciences Department, we are looking to fill the position of a Head of Product Development.
About the Role
The Head of Product Development plays an important role in the Pharmaceutical Sciences department, being an active member of the leadership team and being accountable for all aspects of our small molecule product development deliverables.
Nature and Scope
* To manage all scientific and technical aspects of the early and late phase development, industrialization and project-based lifecycle management of all NCE drug dosage forms and related manufacturing processes in accordance with the departmental mission statements.
* To develop all drug product formulation and manufacturing processes meeting pre-agreed target profiles, fit for purpose at each stage of product lifecycle, starting with initial transfer from R&D to market lifecycle.
* Active provision of strategic guidance for the initiation and management of drug product development and process industrialization projects and for the supply of bulk drug product for pre-clinical studies and clinical trials.
* Efficient and effective management of department resources like staff, facilities and the relevant budgets.
* To develop and establish technology platforms that match department and customer needs.
* The development stage covers products emerging from R&D function and entering pre-clinical and clinical pipeline and extends to project-based lifecycle management of UCB's major marketed products.
* The scope covers early preformulation, the support of toxicology studies, the development of robust and efficient drug porduct formulations and manufacturing processes.
* To ensure the development of robust and efficiency primary packagings.
* The process qualification and validation according to the business and regulatory needs and the support of technical transfer activities of manufacturing process into the assigned launch production units of NCE.
* To act as a guide and mentor for developing staff within the department.
* Define long term strategy for NCE Drug Product Development department including project strategies, technology investments and development of staff
* Contribute to UCB strategy in moving UCB to a biopharma leader position
* Develop and establish a continuous improvement/culture in order to ensure state-of-the-art products and processes
* Management of drug product development programmes according to agreed project targets and to optimize technical solutions to reach fit-to-purpose best balance of quality/time and costs
* Proactive development of creative and effective strategies for IP protection of drug product and manufacturing processes
* Bulk drug product supply of (pre-) clinical, formulation & ICH stability studies, manufactured under cGMP conditions as appropriate
* Coordination of the technology transfer of drug product manufacturing processes from bench to pilot plant and support of the tech transfer to production scale
* Evaluation and implementation of innovative technologies for efficient process development/ process understanding as well as for novel manufacturing processes /steps
* Planning and resource allocation. Evaluate, define and implement optimal outsourcing balance to provide service to all customers whilst maintaining a lean internal organisation
* Overseeing the provision of fit for purpose documentation of all technical work performed by the department.
* Preparation of summary reports on a monthly, annual basis or ad-hoc.
* Coaching and development of the team. Create an atmosphere of learning.
* Elaborate, control and meet financial targets
* Ensure staff training in the necessary quality environment
* Compliance with all appropriate regulations (GMP, HSE, ISO14001..) and SOPs
* Have 10-15 years supervisory/managerial experience in a pharmaceutical or related process R&D environment
* Have proven functional and cross functional leadership skills
* Have extensive knowledge and experience in pharmaceutical drug dosage form development for NCE
* Maintain and grow network with internal and external stakeholders (suppliers, universities, contract manufacturers, regulatory affairs, QA, intellectual property department, human resources,…) that supports the department vision
* Be flexible, a team player and have a positive can do attitude
* Leadership of the group - setting direction for projects and technical investments
* Team building for the leadership team
* Collaboration to drive the relationship with key stakeholders such as our Discovery and Commercial Manufacturing groups
* Be fluent in English (oral and written).
At UCB, growth and profitability constitute a guarantee for stability. You will always have the time and the backing needed to turn your ideas into reality. You can plan your future.
We are building the next generation biopharma leader and need exceptional individuals to achieve this goal. We are looking for enthusiastic and talented professionals who thrive on challenge and change, and who want to make a difference and deliver results
At UCB human talent is the greatest asset of our organization - we continue to strengthen our talent pool, our organization and, our ability to deliver.
You can find out more about the organization at the company's web site: www.ucb.com.
Job Segment: Toxicology, Product Development, Law, Pharmaceutical, Compliance, Science, Research, Legal