Cmc Drug Product Leader
il y a 2 jours
**ABOUT ITEOS THERAPEUTICS, INC**
iTeos Therapeutics is a publicly-traded (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of patients with cancer by designing and developing next generation immunotherapies.
Based in Gosselies, Belgium and Watertown, 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 $230 million of gross proceeds. In June 2021, the Company entered into a transformative $2.145 billion co-development and co-commercialization agreement with GSK for EOS-448, the Company’s anti-TIGIT monoclonal antibody. As a well-capitalized biotech company, we are positioned to continue to develop our clinical pipeline and maintain our investments in our discovery research team to leverage our innovative science to improve the lives of patients with cancer.
Our values - Data Driven, Ownership, Courage, and Stronger Together - form the foundation of who we are as a company and define who we are at our core.
**iTeos Therapeutics is now a world-class actor in the sector. To carry on its growth and reinforce its team, iTeos Therapeutics is looking for a CMC Drug Product Leader.**
**ROLE: CMC Drug Product Leader**
iTeos Therapeutics is actively looking for a creative, resourceful, and organized CMC Drug Product Leader responsible for drug product activities, from early stage to late stage of development and registration, in small molecule projects. Of note, there is no internal laboratory or plant at ITeos, the business model is to subcontract all activities to CMOs and CROs.
**MAIN RESPONSIBILITIES**
- Work closely with the Global Head of CMC to set ambitious goals for the dedicated projects.
- Define the drug product development strategy and lead the drug product development activities at CDMOs.
- Identify, select and Manage Contract and Development Manufacturing Organizations (CDMOs) for drug product development and production, non GMP and cGMP manufacture and scale up in support of ongoing clinical programs, in collaboration with the CMC Project Manager.
- Be the CMC Subject Matter Expert on the development of drug product (oral dosage form essentially) for New Chemical entities, on formulation development, process development, from pilot scale to industrial and commercial scale including PPQ /process validation, according to regulations and standards.
- Manage DP supply chain and logistics in support of clinical studies.
- Manage drug product inventories at subcontractors to ensure availability at key project milestones.
- 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.
- Preparation, review, and approval of drug product source documents for CTA/IND and contribution to response to questions as Subject Matter Expert in drug product activities, in collaboration with the CMC Dossier Manager.
- A strong understanding of the regulatory and compliance requirement for drug product development - Knowledge of ICH, EMA and FDA guidelines
- cGMP, USP and Ph Eur.
- Work with CMC Project Manager to identify the risks linked to the project and ensure mitigation actions are put in place.
- Support the Global Head of CMC and the CMC Project Manager during the budget process.
**PROFESSIONAL EXPERIENCE/QUALIFICATIONS**
- Scientific or technical training or advanced degree (such as Master Degree or Ph.D ), is required.
- At least 15 years of experience in drug product development and industrialization.
- Track record in formulation development, in industrial scale up and preparation for launch.
- Knowledge of traditional oral dosage form production including technologies such as blending, wet/dry/spray granulation, tableting, capsule filling, coating, etc.
- Knowledge of QbD, DoE, CPV (process validation).
- Technical and scientific experience in clinical manufacturing and quality aspects of GMP manufacturing.
- Knowledge of preclinical models in vivo and in vitro and drug delivery aspects.
- Experience working in a cross-functional environment, contributing to cross-functional teams.
- Advances PC skills (Word, Excell, PowerPoint,) and ability to produce reports and presentations.
- Ability to work independently with mínimal supervision as well as part of a team environment.
- Open-minded with excellent interpersonal and communication skills.
- Possesses strong written and verbal communication skills in English.
**OFFER**
- 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.
- An employment agreem
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