Product Development Manager – Pharmaceutical (solid oral dose)
Cambridge
Permanent
£ competitive, depending on skills, background and experience
Scope of the role:
This is an exciting new role which will see you taking responsibility for technical and analytical knowledge of the business product portfolio as well as guiding projects through the commercial phase.
You will work on projects within a range of therapeutic areas including: metabolic, immunology and neurology, exploring a variety of technologies and dosage forms. Building both an internal and external network, your strong commercial acumen and client-facing skills will be invaluable to supporting the businesses' growth plans and patient network.
Responsibilities:
* Technical expert: providing formulation and analytical expertise to support commercial products, in collaboration with product management, and Quality and Regulatory affairs teams.
* Build and maintain strong working relationships with new and existing third party vendors.
* Support commercial manufacture of products through conducting gap analysis, review stability data and help to optimise manufacture process efficiency.
* Investigate issues and risks for commercial projects; design suitable scope of works and manage project execution with CMO’s.
* Keep abreast of regulatory updates, particularly US/FDA.
* Prepare and review technical documentation, work to SOPs and internal protocols.
* Represent the team in budget discussions, identify spend and savings opportunities and contribute to the operational planning around timelines and milestones.
* Train and develop internal stakeholders to ensure they are enabled to progress and develop.
* Suggest methods for improvement of procedures, identify cost and time saving measures and help implement solutions which address efficiency and consistency.
Your background:
* Degree or equivalent in a Life Science discipline.
* Drug product formulation experience which must be from Phase 2 or beyond in either of the following: oral solid dose form or solutions and suspensions.
* Experience with analytical method development and validation would be very beneficial.
* You will have worked with tech transfer processes of product manufacturing to commercial scale.
* Excellent commercial acumen and proven success in client-facing roles.
* Good awareness of ICH guidelines.
* Strong negotiation and influencing skills, particularly in relation to vendor management of third party CMO/CRO’s
* Ability to work independently, with minimal supervision in a dynamic environment with regularly changing demands.
* Results and solutions-oriented, highly organised and collaborative.
If this sounds like it could be your next role, please apply here or contact bec.johnston@srgtalent.com for more information.