This is a rare opportunity to join a young, exciting clinical-stage biotechnology company.
Our client is a clinical-stage company focused on the discovery and development of novel therapies with the potential to fundamentally change the course of progressive, life-threatening diseases
With either a deep knowledge of formulation development or biologics manufacturing underpinning their project management experience, the CMC Development, Senior Director will be responsible for management and delivery of all aspects of the CMC development for assigned early and late- stage program(s).
This will involve managing the development of assets from R&D transition through to commercialization, managing external vendors and internal resources to achieve the program objectives and timelines. A key requirement of the role will be the translation of the target product profile and commercial inputs into a coherent development and supply plan.
In this role the incumbent will be a key member of assigned program teams and will be held responsible for delivering to program timelines and goals. Important interactions will be with Technical Operations clinical supply, centralized project management functions, R&D, Quality and Regulatory Affairs. Experience of managing and achieving aims through a highly externalized model is essential, as is the flexibility for approximately 20% international travel.
A working knowledge of a broad range of biologics drug substance and drug product development and manufacture is required and detailed knowledge of either drug substance manufacture or formulation development is desired.
- Management of external CDMO’s to achieve program goals,
- Lead various scheduled and ad hoc CMC or CMC sub-team meetings
- Assist in the implementation of project related tasks
- Utilize project management tools and best practices to support CMC activities
- Document, track and communicate progress against CMC timelines, milestones and budgets
- Represent the CMC work in all integrated project teams as required
- Assure and track all budget, POs, and payment to CMOs
- M.S./ PhD degree or equivalent, in Life/ Physical Sciences or Engineering
- 15+ years’ experience in Manufacturing / Development in the biopharmaceutical industry
- CMC development experience, with thorough knowledge of biologics and preferably small molecule platforms
- Knowledge and use of Enterprise software and management of budgets
- Demonstrated leadership to drive results that are needed to achieve company objectives in accord with company’s culture and values
- Excellent written and verbal communication; strong presentation skills
- Ability to deal with incomplete information or ambiguity in a composed manner
- Self-organized with strong critical thinking and analytical skills
- Ability to develop strong relationships with external CMOs and internal stakeholders
- Proficient with Microsoft Office (e.g. Word, PowerPoint, Excel) and Microsoft Project
Gerry Kennedy, Managing Director, Recruitment for Technology Ltd. Cv to firstname.lastname@example.org
Maple House, South County Business Park, Leopardstown, Dublin D18 F863