Project Manager Collaborations & Drug Development
At Eligo, we are passionate about developing new drugs to address unmet medical needs!
Eligo is building a platform technology to produce an arsenal of eligobiotics to target a wide range of bacterial species and address a number of diseases in different fields such as infectiology, oncology and immunology. With such a capability, Eligo is poised to lead the new generation of precision microbiome engineering companies.
We are looking for a talented project manager who will work hand-in-hands with both our Research Teams and our Drug Development Team to coordinate a number of projects aiming at transforming our technology into a game-changing product.
These include: the development of the production & manufactuting processes and industrialization; the demonstration of efficacy and innocuity of our lead product candidate and the collaborations with Eligo’s academic and industrial partners.
The ideal candidate has experience in scientific project management and drug development & manufacturing.
The CMC & Collaborations Project Manager will be responsible for:
- the management and supervision of CMC activities relating to manufacturing of Eligo products (nonclinical and clinical grade) under ICH/GLP/GMP requirements
- the budgets and timelines for all manufacturing, CMC and collaboration activities
- the identification of potential issues that could arise in the product development process / collaborations and that are expected to affect the projects outcome.
- The coordination of specific grant writing in relation to the technology
The CMC & Collaborations Project Manager will:
- Work closely with Project Leader for scheduling project CMC and collaborations activities
- Assist in preparing the package of CMC documents for CTA (IMPD, INDs and Investigator Brochure for quality part)
- Present CMC follow up and outcomes to the Project Team
- Work closely with CMO and CRO’s staff to ensure excellent relationships between Eligo and its partners
- Host meetings with potential new partners and contractors to assess capabilities and establish good relationships
- Develop and maintain network of external experts for both data review and strategic proposal for project decision
- Play an active role in reaching timely decisions that resolve the issues
- Carry out project management and operational tasks in order to coordinate multi-functional groups working as CROs/CMOs/Consultants outside the company (Manufacturing process and formulation development for scale-up and technology transfer from pre-formulation work; Analytical Development relating to process manufacturing, and Advanced Therapy Medicinal Product; Quality Assurance & Quality Control; Pharmaceutical Development in charge of Clinical Manufacturing)
The project manager should raise problems and propose solutions to Head of Preclinical Operations. Anticipate when and where issues can arise. He/She will need to be a force of proposition, and propose ideas, preempt challenges and offers solutions.