Occupational & Product Quality Toxicologist
The Global EHS (Environment, Health and Safety) team supports the wider GSK business across the entire product life-cycle (from early stage drug discovery through to manufacture and commercialisation of the product) to ensure the generation of core fundamental EHS information that is required at each stage to avoid harm to people, facilities and the environment and to meet global regulatory requirements.
As an Occupational & Product Quality Toxicologist you will provide key support to allow GSK to identify risks associated with working with chemicals, and to establish internal work practices and controls to protect GSK employees and contractors.
Key Responsibilities
Provides expert toxicology assessments (human health hazard assessments) and guidance for GSK products and process materials across global span of GSK, including development of Health based exposure limits (HBELs): Occupational exposure limits (OELs), Permitted Daily Exposure (PDE) Limits for various modalities (small molecules, peptides, biologics, oligonucleotides, etc)
Provides worldwide training and support in toxicologically related topics, establishes and maintains processes to enable effective communication and education of key stakeholders, maintains the global EHS toxicology database;
Provides expert toxicology review of GSK Safety Data Sheets (SDS) for GSK drug substances, intermediates, mixtures, products etc.
Support to worker safety testing programs at external toxicology labs relevant for hazard characterization for new product and to support chemical registration data requirements
Contribute to projects to ensure regulatory compliance; authoring and/or reviewing reports, protocols, guidelines and standard operating procedures (SOPs) and ensuring harmonized approaches with regard to the toxicological assessments;
Monitor scientific developments and conduct desktop research including literature searches, and critically evaluate and summarise scientific information and government regulations.
Maintain toxicological expertise relevant to nonclinical safety of drugs, environmental science, occupational health, and product quality risk, i.e. keeps up to date with the scientific literature and regulatory guidance, attends and contributes to relevant professional/scientific meetings, and publishes in peer reviewed journals, if appropriate
About You
This role would suit an ambitious, proactive and motivated individual who has strong relevant experience. Excellent people skills are important. You will also have a keen interest in continuous improvement and a willingness to work towards standardised and lean working practices. Experience with global chemical regulations and hazard assessments would be advantageous.
Basic Qualifications:
Strong understanding of the toxicology field
Master’s degree or equivalent in toxicology/pharmacology or related
Research skills with literature searches, toxicology databases, regulatory databases and computational tools
Project planning, tracking and management skills to ensure actions and commitments are delivered to plan
Preferred Qualifications
Experience in regulatory toxicology, gained in pharmaceutical / biopharmaceutical, chemical, or related product manufacturing
Professional Qualification/Certifications
An understanding of Globally Harmonized System (GHS) for classification and labelling of chemicals and the EU Classification, Labelling and Packaging (CLP) regulation and other relevant global regulations.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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