Job Description
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
Reporting to the Senior Vice President of Technical Operations, the Associate Director, CMC Project Manager will manage and delivery all aspects of the CMC development programs.
This will involve managing the development of assets from Research transition to commercialization, managing external vendors and internal resources to achieve the program objectives and timelines.
In particular, the incumbent will be responsible for effective oversight from a financial and reporting perspective for all programs, supporting the CMC Program Leads and Supply Chain Management.
Job Spec
- 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
Person Spec
- B.S./M.S. degree or higher, preferably in Life/ Physical Sciences.
- MBA and/or Project Management Qualification (PMI) a plus
- 10+ years’ experience in a Manufacturing/ Development environment in the biopharmaceutical industry
- CMC Program management experience, with thorough knowledge of biologics and preferably small molecule platforms
- Knowledge and use of Enterprise software and management of budgets
- Proficient with Microsoft Office (e.g. Word, PowerPoint, Excel) and Microsoft Project.
- 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
- Demonstrated leadership to drive results that are needed to achieve company objectives in accord with company culture and values.
Cv to gerry@rftgroup.ie 01 2302400