Offre d'emploi : CMC Lead
iTeos Therapeutics is a publicly-held (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing next generation immunotherapies.
Based in Gosselies, Belgium and Cambridge, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UCLouvain) in 2011.
In March 2020, the Company completed a $125 million Series B2 financing, and in July 2020, we completed our IPO raising over $230million of gross proceeds. In June 2021, iTeos entered into a transformative $2.145 billion co-development and co-commercialization agreement with GSK for EOS-448, iTeos’s anti-TIGITmonoclonal antibody. As a well-capitalized biotech company iTeos is positioned to continue to develop our clinical pipeline and maintain our investments in our discovery research team to leverage our fantastic science to improve the lives of cancer patients.
For more information, please visit www.iteostherapeutics.com.
iTeos Therapeutics is now a world-class biotech in cancer immunotherapy. To carry on its growth, expand its pipeline and reinforce its team, iTeos Therapeutics is looking for a CMC Lead.
iTeos Therapeutics is actively looking for a creative, resourceful, organized and responsible CMC Lead to coordinate the CMC operational aspects of one or more therapeutic development projects at early stage, in collaboration with the Research team. This position will report to the Global Head of CMC and will work closely with one or more Project Leaders, Project Managers and Project Team members across all the functions involved in the projects including Medicinal Chemistry, Regulatory, Clinical/Clin Ops, Translational Medicine and Preclinical. The successful candidate will be a proactive and collaborative CMC project manager with experience working in an early clinical development environment. Ideally, the candidate will have experience with both biologics and small molecules at an early stage of development but those with broad experience in biologics only are also welcome to apply.
- Work closely with the Global Head of CMC to set ambitious goals for the dedicated projects.
- Work closely with the Research Team for a smooth transition from Research to Clinical stage development in CMC.
- Participate in the identification and selection of Contract and Development Manufacturing Organizations (CDMOs) and subcontractors from the RFI to the final choice:
- Ensure preparation of RFPs and analysis of responses received.
- Participate in subcontractor qualification visits and audits.
- Manage Contract and Development Manufacturing Organizations (CDMOs) for process development and optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs.
- Participate in the development of analytical or bioanalytical methods, CoAs, specifications, stability plans and validation of analytical methods based on development phases.
- Manage of supply chain and logistics in support of clinical studies.
- Manage drug substance inventories at subcontractors to ensure availability at key project milestones.
- Project API and DP needs for preclinical and clinical programs (with clinical team).
- In coordination with Quality Assurance, implement stage appropriate protocols to ensure that all CDMOs are using systems and processes in compliance with all relevant regulatory standards.
- Execute plans for the validation and registration of API and DP as required by cGMP, ICH and FDA regulations.
- Write and review documents for INDs/IMPD/regulatory section submissions.
- Participate in cross functional project teams encompassing all aspects of discovery (e.g. lead generation), preclinical (e.g. toxicology), and clinical trial execution.
- Review or edit cGMP batch records, CMC regulatory and Quality documents.
- Ensure activities are completed on time and/or impact of any delay on the project in communicated promptly to Global Head of CMC and Project Leader(s)/Manager(s) and corrective actions are put in place.
- Work with Project Manager to identify the risks linked to the project and ensure mitigation actions are put in place.
- Support Global Head of CMC during the budget process.
- Scientific or technical training or advanced degree (such as Master Degree, Pharm.D., or Ph.D.) is required.
- 8+ years of technical/operational experience in CMC within the biopharmaceutical industry.
- Substantial experience working with international Contract Research and Manufacturing Organizations (CROs and CMOs) for the production of DS and DP.
- Experience with projects in preclinical and clinical development including parenteral dosage forms, as well as experience with supply chain management.
- Experience working in a cross-functional environment, contributing to cross-functional teams.
- Thorough understanding of the drug development process from preclinical steps through IND/CTA submission.
- Committed and detail-oriented, you have a strong sense of time management and a good ability to adapt to changes in priorities.
- Open-minded with excellent interpersonal and communication skills.
- Fluency in English, both written and oral.
- A stimulating position within a high-potential innovative biotech company.
- The opportunity to work in a science-driven, dynamic, respectful and professional environment.
- A challenging scientific and business growth in which you get to bring your knowledge and skills.
- A permanent contract with an attractive salary package in line with the position responsibilities and your experience.
Send your CV together with an adapted cover letter via https://www.pahrtners.be/en/jobs/cmc-project-manager-early-phase-mf-en/ or to the following address: firstname.lastname@example.org.
Your application and related information will remain strictly confidential.