Office (Earby) | Salary Negotiable/Competitive Pension + Annual Bonus Scheme

Do you want to be part of a fast-growing, globally recognised Scientific and Regulatory company?

If you do, we want to hear from you as we have an exciting Principal Scientist role within our growing Chemistry team.

Main Purpose of Job

The Principal Scientist will be an accountable scientific consultant within the Chemistry team.  This team will be a collection of Subject Matter Experts (SME’s) covering scientific capabilities across the global regulatory ENDS markets.The team will be known for their scientific knowledge and consultancy capabilities in ENDS, backed by the Broughton Nicotine Services (BNS) analytical laboratory teams. They will be experts in the science involved in regulatory submissions for PMTA, MAA etc, communication and project management.  The team will have a can-do attitude to this disruptive ENDS market with the drive to create a smoke-free future. Lowering the barrier for ENDS regulatory compliance by applying innovative scientific expertise will be a key success factor for this team.  ‘Learn Quickly’ will be their motto.

The role is responsible for utilising business resources to lead rapid validated learning in the disruptive ENDS market.  The role requires sound commercial acumen.  The role is responsible for taking informed risks and making rapid business decisions.   

Key Tasks & Accountabilties

• Take accountability as the Module 3 / Chemistry subject matter expert (SME) and workstream lead for new product development, pre-market regulatory submissions (e.g. PMTA, MRTP, MAA, TPD) and post-market compliance.
• Develop and implement innovative regulatory strategies to support new product market authorisations.
• Conduct Gap Assessments of Module 3 / Chemistry for new client projects and prepare scientific study designs and recommendations
• Create sampling and testing strategy and plans for ENDS regulatory projects (e.g. FDA PMTA, MHRA MAA)
• Write Module 3 / Chemistry dossier narratives and provide critical technical reviews of cross-functional workstreams to ensure alignment on regulatory strategy.
• Take accountability for analysing scientific data, interpreting and communicating hypotheses effectively through written and verbal communications.
• Provide scientific consultancy to support commercial marketing activities. This may include product strategy, product pricing and product promotional activities.
• Write scientific publications / speak at events on specific areas of scientific expertise and innovations aligned with marketing activities.
• Provide scientific consultancy to support commercial sales activities to win new clients. This may include input into commercial proposals, acting as the technical SME on sales calls, presenting to clients during visits.
• Write Technical / Project Synopses and work instructions.
• Take responsibility as primary Technical / Scientific Relationship Manager for a portfolio of key clients. As the SME, you would be the fountain of scientific and regulatory knowledge when communicating with the client / stakeholders.
• Arrange client visits and take lead role in co-ordinating technical review meetings. Document meetings minutes effectively and co-ordinate completion of actions.
• Take responsibility for self-teaching in this ENDS emerging markets and driving a rapid ‘validated’ learning culture for yourself and where appropriate, your team.
• Communicate validated-learning to help develop other team members and support commercial activities.
• Take responsibility for Project Managing the regulatory science aspects of client projects (e.g. managing the analytical activities required for an ENDS PMTA). The overall project may be managed by an external client and/or Broughton PMO.
• Liaise with other work-stream leads to ensure chemistry strategy documents are aligned across regulatory projects.
• Ability to work effectively and efficiently both within regulated environments (e.g. GMP/GLP) and agile R&D environments.
• All personnel involved in the conduct of a GLP regulatory study must be knowledgeable in those parts of the principles of good laboratory practice which are applicable to their involvement in the study.
• Comply with the instructions given in test methods/study plans etc. Any deviation from these instructions should be documented and communicated directly to line manager or study director/principal investigator for GLP studies.
• Train and coach internal scientists against agreed training initiatives
• Commit to create a smoke-free future.
• Perform other duties as and when required by the company.
• Act at all times in the best interest of the company.

Key Person Specification

• Graduate of Science, Chemistry or Analytical Chemistry related subject (PhD is desirable).
• Experience (10 plus years) of working in a regulated science and/or research analytical laboratory environment. An appropriate PhD is considered within this experience.
• Proven ability in technical writing and communications.
• Proven self-learner.
• Can demonstrate business / commercial acumen.
• Proven project management skills.
• Can demonstrate drive and motivation.

People Responsibilities

• This role may include immediate line management reports.
• Will be responsible for training, mentoring and coaching team members.

Limits of Responsibilities

• The post holder is not responsible for strategic decisions.
• The post holder is not responsible for analytical operations.

Travel Requirements

• There will be a requirement to travel to client sites / attend events which will include travel predominately within the UK, EU and US.

Competencies

Background Information

Broughton Nicotine Services is a privately-owned global analytical services business. We are an FDA and MHRA inspected laboratory focused on delivering a high-quality service for industry-leading clients in the electronic nicotine delivery systems (ENDS) industries.  Whether it's innovation or optimisation, Broughton Nicotine Services tackles the toughest challenges from product analysis to product stewardship programmes.

We are an equal opportunities employer. We aim to recruit staff on their suitability for the position advertised, without consideration of age, sex, marital status, disability, age or ethnic origin.

Due to the anticipated number of applicants it is not possible to respond to each individual application.

If you are not successful in progressing further through the application process then your CV, personal details and application form will be deleted in accordance with data protection laws.