Make your mark for patients
UCB, Brussels, Belgium 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. With more than 8 500 people in about 40 countries, the company generated revenue of € 4.5 billion in 2017. UCB is listed on Euronext Brussels (symbol: UCB)
To strengthen the Non-Clinical Safety, part of Development Science Function, located at its European Research and Production site, we are seeking a talented individual to fill the position of Chemical and environmental safety officer (CESO), based in Belgium, Braine-l’Alleud.
You will be responsible for the toxicological support brought to cross-functional risk assessments of impurities (general, elemental, mutagenic, nitrosamines, excipients, contaminants, extractables and leachables), environmental risk assessments linked to chemical and biological therapeutic modalities and REACH registrations of UCB synthesis intermediates.
You like to work in an environment where you can:
- Provide expertise and know-how cross-functionally and across different UCB sites
- Interact with in-depth knowledge on subject matter area, regulatory requirements and guidelines related to chemical and environmental safety
- Build collaborative networks to facilitate cross-functional communication and activities
Hybrid office situation (2days minimum on-site / 3days remote)
Traveling may be required
You will contribute by:
- Writing and monitoring risk assessments for impurities (eg, justification of specifications, elemental impurities risk assessments, extractables and leachables, degradation products, ICH M7-compliant evaluations, etc.)
- Planning, coordinating and monitoring the conduct of toxicology studies at contract research organizations in line with project timelines and budget
- Performing and monitoring toxicological risk assessments for various health-based exposure limits (PDEs, ADIs, etc.)
- Performing and monitoring environmental risk assessments (ERAs) and oversee the conduction of environmental studies to support such assessments.
- Authoring and/or reviewing reports, protocols, guidelines, guidances and SOPs and ensuring harmonized approaches with regard to the toxicological assessments
- Representing the non-clinical safety team in cross-functional meetings
- Providing support in the construction of CMC regulatory documents and positional papers (i.e., IND/NDA documents, MAA, etc.)
- Providing support to HS&E in the interpretation of toxicological study data produced in the context of REACH or CLP regulations
- Maintaining traceability of the assessments performed and the reports produced
- Maintaining adequate knowledge in the chemical and environmental field through conference attendance, training and benchmarking
Interested? For this position you’ll need the following education, experience and skills:
- Doctoral degree (Ph.D., PharmD) or Master degree in Toxicology or related life-science discipline (eg Biology/Pharmacology/Pharmaceutics/Biochemistry)
- Minimum of 8 years pharma industry experience
- Minimum of 3 years direct experience in providing toxicological input on ERAs, Impurities risk assessments, REACH registrations
- Effective oral and written communication skills at all levels of interaction, in English and French
- Understanding of regulatory processes, Good Laboratory Practice (GLP) regulations and extensive knowledge in regulatory toxicology
- Ability to interact collaboratively with diverse working groups in an international team-oriented environment and with groups outside of the organization
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
- Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Preferred Qualifications:
- Accredited or registered toxicologist
- Experience working on the development of chemical entities, peptides, and biologics is desirable. Experience with gene therapies is an asset.
- Experience in the pharmaceutical/biotechology industry performing non-clinical safety risk assessment activities throughout all stages of drug development, including monitoring nonclinical studies, interpreting data, generating and reviewing reports and contributing to the generation of regulatory documents
- Hands-on experience generating safety risk assessments
If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.
RANDATUCB
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!
About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
Why work for us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
Learn more about sustainability at UCB and how it is integrated into our business approach.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
