Published: 20/10/2020
Job description:
Confo Therapeutics, a spin-out of VIB and VUB, is a drug discovery company built around a disruptive technology which enables it to address ‘undruggable’ GPCRs. The company is building a portfolio of transformative medicines in various disease areas. Confo Therapeutics is currently located on the Etterbeek campus of the Vrije Universiteit Brussel and on the Technology Park in Zwijnaarde/Ghent. More information about Confo’s technology and strategy can be found on www.confotherapeutics.com.
For the expansion of our drug development team in Ghent we are currently looking for a (m/f):
CMC Development Program Manager, Small Molecules (Ghent, Belgium)
Your responsibilities:
- Lead Chemistry, Manufacturing and Controls (CMC) activities for Confo small molecule development projects
- As a member of the development team reporting to the Chief Development Officer, work with the team and with CMC consultants and designated contract development and manufacturing organizations (CDMOs) to facilitate successful project execution, achievement of key deliverables and of budget and FTE goals
- Collaborate cross functionally with internal and external stakeholders such as Discovery, Regulatory Affairs, Toxicology, Medical / Clinical and Quality
- Lead and contribute as appropriate to internal and external scientific / CMC discussions
- Provide CMC support to project teams by:
- Building project timelines and managing the critical path
- Translate strategies into CMC operational plans
- Developing CMC project budgets and budget forecasts
- Developing and analyzing scenarios, risk assessment and mitigation planning
- Participate in consultant and CRO selection activities
- Develop, liaise with and manage resources (FTE, CRO and consultant budgets)
- Team governance support as required
- Support monthly, quarterly and major financial budget cycles
Your profile – Technical Skills:
- PhD or equivalent in a scientific discipline, or/and at least 7 years of relevant experience in the pharmaceutical industry and drug development is essential
- Knowledge of and experience in small molecule drug development, specifically CMC functions, is essential, including e.g. familiarity with drug substance (essential) and/or drug product development, analytical development and stability programs, clinical trial materials, manufacturing, and quality and regulatory requirements
- Experience in Project Management is essential
- Biologics CMC experience is a plus
- Experience in clinical development and clinical supplies is a strong plus
- MS Project knowledge is a strong plus
Your Profile – Personal Skills
- Works towards a trusting team environment by practicing transparent and open communication to facilitate team alignment around corporate and project goals
- Interacts constructively with internal and external collaborators, including consultants, vendors and team members
- Demonstrates adaptability and is a quick learner, contributes beneficially to establishing a fast-paced, entrepreneurial and multicultural environment
Our offer:
- A competitive compensation package with extensive benefits
- An entrepreneurial and stimulating working environment in a growing and ambitious biotech company
- Travel may be required e.g. to visit CMC sites
Do you have the right qualifications and are you up to the challenge of joining our entrepreneurial team? Then forward a short motivation letter and your CV with description of your technical expertise to careers@confotherapeutics.com.
