Salary & Benefits
Competitive depending on experience, plus generous benefits package, including:
30 days holiday per year (plus bank holidays) • free onsite car parking • Generous pension plan
Location
Remote
Join our team and contribute to cutting-edge research in a collaborative and innovative environment.
Summary of the Role
The Scientific Consultant provides expert scientific and regulatory support for projects related to drug development and safety assessment. This role involves conducting and interpreting toxicological and chemical safety evaluations, advising on regulatory strategies, and ensuring that all scientific justifications meet global standards.
The consultant works closely with clients and cross-functional teams to deliver evidence-based insights, integrating tools such as Lhasa Limited’s predictive toxicology software and applying relevant ICH and regulatory guidelines.
By combining technical expertise with strategic thinking, the Scientific Consultant helps organizations make informed, scientifically sound decisions that support the safety, quality, and compliance of pharmaceutical products.
Main Responsibilities
Duties include but are not limited to:
- Perform toxicological and regulatory assessments of organic, inorganic, and mutagenic impurities, in alignment with ICH guidelines and regulatory requirements from agencies such as Anvisa, EMA, FDA, etc.
- Work across all service pillars of Consult Lhasa, including impurity formation, potentially mutagenic impurities, nitrosamines, and non-mutagenic impurities.
- Use in silico tools to predict impurity formation, identify toxicological alerts, and support scientific justification of acceptable limits.
- Prepare and deliver high-quality scientific reports and regulatory justifications to support clients.
- Conduct literature reviews and analyse toxicological data to support risk assessments and regulatory strategies.
- Provide technical support to clients on impurity control strategies and regulatory expectations.
- Collaborate in multidisciplinary projects.
- Stay current with evolving regulatory guidelines and scientific methodologies relevant to impurity risk assessment
- Support internal Quality Assurance processes by reviewing scientific deliverables, ensuring consistency, regulatory alignment, and documentation integrity.
- Respond to client requests in a timely manner.
- Take ownership and deliver to deadlines.
About you
- An undergraduate degree, masters, or PhD in a relevant scientific field.
- Knowledge of toxicology, metabolism, degradation, and organic reaction mechanisms.
- Knowledge of ICH guidelines (Q3A/B, Q3C, Q3D, M7) and relevant regulatory frameworks (FDA, EMA, ANVISA, MHRA)
- Proficiency in applying in silico predictions desirable.
- Ability to analyse and interpret scientific data and translate it into regulatory or business recommendations.
- Strong relationship-building skills and the ability to work effectively in a team environment.
- Excellent written and verbal communication skills, including the ability to explain complex scientific concepts clearly to non-specialist audiences.
- Experience in customer-facing roles, ideally in a scientific or technical environment
- Excellent scientific communicator, with the ability to provide and receive constructive feedback.
- A proactive mindset, with the ability to take initiative and problem solve.
- Client-focused, adaptable, and proactive in identifying opportunities for scientific improvement or innovation
- Negotiation and leadership skills.
- Enjoys working both independently and as part of a diverse, multidisciplinary team.
- Strong interpersonal skills with sensitivity to cultural differences.
- Willingness and ability to travel frequently
When applying please include a cover letter outlining why you interested in a client-facing role rather than a purely lab-based position along with your experience of using in-silico tools.