Key Responsibilities:
- Conduct safety assessment of impurities in drug substances and medicinal products spanning all therapeutic modalities and disease indications (including extractable and leachables, elemental impurities, degradation products, and excipients)
- Perform ICH M7 in silico assessments to evaluate the presence of potential mutagenic impurities
- Provide expertise to support Nitrosamine impurity evaluations
- Provide expert opinions on impurity safety assessments to support drug discovery and development project teams, regulatory submissions, due diligences, and life-cycle management of established medicines.
- Develop innovative interdisciplinary approaches to advance the field of impurity safety assessment across all therapeutic areas and advanced modalities (e.g. Bx, GTx, xRNA, RLT)
- Maintain state-of-the-art scientific and regulatory expertise in Impurity Safety.
- Lead cross-functional teams; represent the PCS line function on internal and external boards; actively share and communicate information back to the Impurity Safety team
- Engaging and collaborating with key internal and external customer partners
- Ensure compliance with relevant regulatory guidelines and standards.
Essential Requirements:
- PhD, DVM or equivalent
- Broad knowledge in toxicology and chemistry
- Knowledge of the drug development process
- Minimum of 5 years of experience in regulatory impurity safety assessment
- Experience in health authority interactions
- Knowledge of design and application of impurity safety databases, experience in the area of QSARs
- Strong analytical skills and a commitment to scientific excellence.
- Excellent communication and team collaboration skills.
Desirable Requirements:
- Strong data exploration and analysis skills.
Salary
Competitive
Monthly based
Location
London, England, United Kingdom
Job Overview
Location
London, England, United Kingdom