Our Client develops and distributes licensed and unlicensed medicinal products. They use proprietary drug delivery technologies to reformulate existing medicines, to create bespoke products to address the unmet medical needs of patients with niche diseases. The strategic intent of our client is to develop and register more products as licensed medicines, applying for Marketing Authorisation’s whenever commercially justified.
Our Client uses trusted contract development and manufacturing partners to produce their medicines, which they distribute in the UK and overseas via distribution partners. They are committed to the highest quality standards in their business, and to operating within the Medicines and Healthcare products Regulatory Agency (MHRA) regulatory framework.
Due to continued expansion, they are now seeking a Product Development Specialist to manage pharmaceutical product development projects.
This position is a full-time permanent role. The position will be office based in Surrey with occasional travel.
* Research, identify and define technically viable and pragmatic product development opportunities and take day-to-day responsibility for their management.
* Identify and recommend the best contract development and manufacturing partner for each project.
* Ensure that the projects are being run according to agreed timelines, costs and that appropriate robust decisions are made at each stage of the project.
* As required liaise with contract development and manufacturing facilities to assist in identifying optimum solutions to product development and manufacturing problems.
* Monitor, record and attribute costs associated with projects.
* Clearly communicate with internal and external stakeholders, reporting on project progress and challenges as appropriate.
* Ensure documentation at the contract development and manufacturing partner is prepared and signed off in advance of a decision being implemented.
* Accurately document agreed activities.
* Complete Quality Management System documentation.
* Work within the Company procedures and processes.
* Travel to and spend time as required at supplier, contract manufacturer or other potential partner sites.
* Internal: Commercial – UK, Middle East and Australia, QA.
* External: Contract Developers, Manufacturers, Suppliers, Distributors.
Qualifications / Experience
* BSc or equivalent science based degree (minimum).
* Prior experience of working in a pharmaceutical production or development environment, to include working with staff and issues arising.
* Familiar with the GxP systems.
* Experience of managing product development or product change projects including planning, documentation, cost control and communication.
* Ability to establish and maintain effective working relationships with internal and external stakeholders.
* Progression of project plans to agreed time lines, costs and successful outcomes.
* Clear and effective communication to colleagues and internal and external stakeholders.
In return our client is offering a competitive package for the successful Candidate including a basic salary of £45,000 - £55,000 per annum (negotiable dependent on experience) plus benefits.
To apply for the above position, please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd
Product Quality Assurance