De vacature betreft een positie bij Janssen Pharmaceutical companies van Johnson & Johnson in Beerse (Antwerpen), België.
Requisition ID: 1700173365W
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
In Janssen Research & Development, LLC, we discover and develop innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
Please visit http://www.janssenrnd.com/ for more information.
In all phases of drug discovery and development, regulatory requirements drive the completion of human health risk assessments of active pharmaceutical ingredients (APIs) and synthetic chemistry process intermediates (INTs). We do this to help ensure worker safety and product quality. The requirements for these assessments are continuously increasing and are now required to be performed by toxicologists.
We are hiring a Senior Scientist Occupational Toxicology, who will manage the testing programs for INT's and will be accountable for the completion and communication of these assessments of intermediates throughout the product lifecycle, from R&D to manufacturing. The majority of these INTs are unique to Janssen, as they as are not used in any other synthetic process and by no other pharmaceutical company. The intermediates need to be compliant with the EU REACH regulation, which now requires toxicology data and input from a toxicologist.
What are your main responsibilities?
You apply skills and knowledge to all stages of API synthesis. You support NME progression by supporting the establishment of health-based permitted daily exposure levels (PDEs) for INTs to assure quality production of APIs in facilities (i.e. pilot plants, manufacturing, etc.) where equipment is shared for the synthesis of numerous APIs (non-dedicated facilities). You classify INTs in R&D based on hazards into a performance-based occupational exposure limit (PBOEL).
You lead the testing of intermediates, including assay selection and design, you interact with customers, adjust workflow, identify new partners, and validate CRO's. You interpret study results for use in risk assessments. You stay current on international REACH-like testing requirements.
You handle study monitoring and all study monitoring activities.
You support Environment, Health, Safety and Sustainability by providing technical guidance, training and hazard information to all domestic and international companies in the pharmaceutical sector of J&J on a wide variety of occupational health, safety, hazard information and INT handling issues (i.e. safety data sheet reviews, maternity assessment, reproductive hazards, compound-specific training, etc.).
You are part of the Pharma Occupational Toxicology Advisory Committee to peer-review assessments performed by contractors/colleagues
You coordinate peer-reviews of assessments, needed for intermediates (i.e. address issues, resolve questions, interact with Preclinical Development Leads, manage approval by consensus of the committee, etc.)
You assist in the qualification of consultants as needed.
You work effectively in a wide range of cross functional teams. You work collaborative with internal groups (Toxicology leads, pharmacokinetics experts, clinicians, etc.) to increase efficiency and scientific integrity. You collaborate with external groups (i.e. non-government organizations, etc.) to continue addressing new issues in risk assessment, impact emerging regulations and continue to grow the science.
You support in maintaining regulatory compliance and knowledge in global regulations pertaining to worker safety, product quality management and REACH-like activities. You go to outreach activities to influence regulatory decisions.
You participate in cross-training with other functions (i.e. API risk assessments, hazard communication, DNELs, GHS, etc.) in Occupational Toxicology to support internal knowledge base and succession planning.
You Support areas outside Janssen Occupational Toxicology/Product Quality as needed.
Are you the person we are looking for?
You have a PhD in Toxicology or in a related area
You have build 8-10 years of relevant industry experience
You are experienced in Risk Assessment or Public Health
You have been working in a regulatory environment
Your written and oral communication skills in English are excellent
Your prior journal publications and peer reviews, are more than a plus
You are open for training to develop your knowledge, continuously improve and increase effectiveness..
You look to advance the science of risk assessment in setting health-based limits
DABT certification is preferred
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Janssen Pharmaceutica N.V. (7555)