CMC Lead - Drug Substance (NCE) (M/F)

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 team, iTeos Therapeutics is looking for a (m/f) CMC Lead – Drug Substance (NCE).

Responsibilities:

iTeos Therapeutics is actively looking for a creative, resourceful, organized, and responsible CMC Lead – Drug Substance to coordinate the operational activities for NCE development, for one or more therapeutic development projects. This position will report to the Global Head of CMC and will work closely with one or more CMC Project Managers, 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 Lead – Drug Substance with experience working from early to late-stage clinical development environment.

Key responsibilities:

• Be the CMC Subject Matter Expert on the development of New Chemical entities according to regulations and standards.
• Work closely with the Research Team, in particular with Medicinal Chemistry, for a smooth transition of NCE 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 API synthesis route development and optimization, non GMP and cGMP manufacture and scale up in support of ongoing clinical programs, in collaboration with the CMC Project Manager.
• Participate to solid state development (characterization, salt screening, polymorphism, crystallisation).
• Participate in the development of analytical methods, specifications, CoAs, stability plans and validation of analytical methods based on development phases.
• Manage DS supply chain and logistics in support of clinical studies.
• Manage drug substance 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.
• Execute plans for the validation and registration of API as required by cGMP, ICH and FDA regulations.
• Write and review documents for INDs / IMPD/ regulatory section submissions for DS sections
• 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 is communicated promptly to Global Head of CMC and CMC Project Manager to ensure that corrective actions are put in place.
• Work with CMC Project Manager to identify the risks linked to the project and ensure mitigation actions are put in place.
• Support Global Head of CMC and CMC Project Manager during the budget process.

Profile:

• Scientific or technical training or advanced degree (such as Master’s 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.
• 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.

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.
• A permanent contract with an attractive salary package in line with the position responsibilities and your experience.

Interested? 

Send your CV together with an adapted cover letter via https://www.pahrtners.be/en/jobs/cmc-lead-drug-substance-nce-mf-en/ or to the following address: recruitment@pahrtners.be. 

Your application and related information will remain strictly confidential.