Job Description
This is a rare opportunity to join a young, exciting high achieving clinical-stage biotechnology company.
Our client is a clinical-stage neuroscience 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/Director, External Drug Substance Development will be responsible for management and delivery of all aspects of development and manufacture of biologic drug substance. 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 CMC teams and will be held responsible for delivering to program timelines and goals. Important interactions will be with other members of Technical Operations in particular the CMC Project Leads, 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 detailed working knowledge of biologics drug substance development and manufacture is required with a proven track record of achievement of goals in both early and late stage.
Responsibilities:
- Management of external CDMO’s to achieve program goals
- Lead various scheduled and CMC sub-team meetings
- Assist in the implementation of project related tasks
- Development of program specific drug substance supply strategy from cell line development to commercialization and life cycle management.
- Utilize project management tools and best practices to support CMC activities
- Document, track and communicate progress against CMC timelines, milestones and budgets
- Represent the drug substance 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 a Manufacturing/ Development environment in the biopharma industry
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 core values
Gerry Kennedy, Managing Director, Recruitment for Technology Ltd. Cv to gerry@rftgroup.ie
Maple House, South County Business Park, Leopardstown, Dublin D18 F863