Cmc Drug Product Leader

Il y a 6 mois

Gosselies, Belgique iTeos Therapeutics Temps plein

**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

  • Laboratory Group Leader

    Il y a 6 mois

    Gosselies, Belgique CellCarta Temps plein

    **Laboratory Group Leader** **Summary** Reporting to the Director of Clinical Operations, the Laboratory Group Leader is responsible for day-to-day management of Research Assistants along with coordinating laboratory work for all ongoing studies. Additionally, the Laboratory Group Leader will ensure that employees are properly trained and competent with...

  • Laboratory Group Leader

    il y a 1 mois

    Gosselies, Belgique CellCarta Temps plein

    **Laboratory Group Leader** **Summary** Reporting to the Director of Clinical Operations, the Laboratory Group Leader is responsible for day-to-day management of Research Assistants along with coordinating laboratory work for all ongoing studies. Additionally, the Laboratory Group Leader will ensure that employees are properly trained and competent with...

  • Technical Leader

    Il y a 6 mois

    Gosselies, Belgique Catalent Temps plein

    Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas...

  • Principal Scientist or Associate Director Medicinal

    Il y a 3 mois

    Gosselies, Belgique iTeos Therapeutics Temps plein

    **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...

  • Senior Finance Manager

    Il y a 7 mois

    Gosselies, Belgique Catalent Temps plein

    Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully...

  • Lead Factory Hébergement

    Il y a 6 mois

    Gosselies, Belgique ORES Temps plein

    Description du poste **Intitulé du poste**: - Lead Factory Hébergement H/F/X **Contrat**: - Durée indéterminée **Service**: - Infrastructures & Operations **Contexte**: - La Factory Hébergement au sein de la Direction Informatique, et plus précisément du département I&O, est responsable du design, du build, du support 3ème ligne et de la...

  • Research Assistant

    Il y a 6 mois

    Gosselies, Belgique CellCarta Temps plein

    **Research Assistant (evening and weekend rotation) - Immunology / Serology** **Summary** Reporting to the Laboratory Group Leader, the Research Assistant will work as part of a team focused on the characterization of the cellular and humoral immune response. The main responsibilities include flow cytometry, viral neutralization assays and ELISA assays....

  • Senior Research Associate, Protein Chemistry

    Il y a 6 mois

    Gosselies, Belgique Neuvasq Biotechnologies Temps plein

    _**Neuvasq Biotechnologies**_ is a high-potential innovative preclinical-stage biotech company dedicated to extending and improving the lives of patients with _**CNS disorders**_, including those suffering from _**vascular retinopathies**_. Neuvasq’s science aims at safeguarding or restoring the integrity of the _**Blood-Brain**_ and _**Blood-Retinal...

  • Scrum Master

    Il y a 6 mois

    Gosselies, Belgique ATCON GLOBAL Temps plein

    **Location**:Gosselies(2 days/week onsite) **Languages**: French(C2) **Employment Type**: Freelance **Start Date**: ASAP **Context of the mission / Objective(s) of the job** The Scrum Master's mandate is to guide Agile teams through the "Scrum" framework, in an attitude of "servant leader" and facilitator. It helps the team to work autonomously and...

  • Qc Specialist Flow Cytometry

    Il y a 7 mois

    Gosselies, Belgique Catalent Temps plein

    Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies onto the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, Catalent’s teams are...

  • Director, Marketing

    Il y a 2 mois

    Gosselies, Belgique Thermo Fisher Scientific Temps plein

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office - When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion...

  • Executive Account Director, Business Development

    Il y a 4 mois

    Gosselies, Belgique Thermo Fisher Scientific Temps plein

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office - At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed...

  • Aprico Consultants

    il y a 4 semaines

    Gosselies, Belgique Aprico Consultants Temps plein

    At Aprico Consultants, we do what we say and we say what we do. Transparency is key. We like people who are eager to learn, just like we are. Because growing means learning. We can't wait to welcome you as the newest member of the Aprico family. Working for Aprico Consultants in one word: Ambition? Passion? Excellence? Development? Fulfilment? Of...

  • Eu Export Administrator

    Il y a 6 mois

    Gosselies, Belgique AMI Metals Temps plein

    **COMPANY DESCRIPTION**: **_COME WORK FOR A LEADER IN THE AEROSPACE INDUSTRY!_** **Position Summary**:This person’s responsibilities include the implementation of AMI Metals (UK, SPRL) and Reliance Steel & Aluminum’s export compliance policy and assuring AMI Metals complies with export regulations, training of personnel, classifying products and...