The Global Head of CMC will be responsible for all CMC-related activities across the portfolio including process and analytical development, manufacturing, formulation and manufacture and supply of clinical trial materials. The ideal candidate will be a highly motivated individual with experience and interest in working in an entrepreneurial environment with broad responsibilities and opportunities. Ideally, the candidate will have experience with both biologics and small molecules but as the successful candidate will have the opportunity to build a small team, those with broad experience in one or other specialties are also welcome to apply.
- Take overall responsibility for all drug substance and drug product activities from preclinical development through clinical supplies for Phase 3 registration studies.
- Identify, select and 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
- Develop and oversee the manufacturing supply chain and deliver robust, scalable and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile.
- Manage of supply chain and logistics in support of clinical studies.
- Project API and DP needs for preclinical and clinical programs (with clinical team), and associated budgets (with finance team).
- Design and development of formulation for clinical programs.
- 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 / regulatory section submissions; represent the company as the CMC expert before U.S. and European regulatory authorities.
- 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.
- Prepare technical reports, publications and oral presentations.
- You hold a Master’s degree, PhD or PharmD in Life Science.
- You have at least 10 years of relevant industry experience.
- You have a substantial experience working with international Contract Research and Manufacturing Organizations (CROs and CMOs) for the production of APIs, DS and DP.
- You have a deep understanding and experience in cGMP operations. Experience with Quality by Design (QbD) will be an advantage.
- You have experience with projects in preclinical and clinical development including oral and parenteral dosage forms, as well as experience with supply chain management.
- You have experience working in a cross-functional environment, contributing to cross-functional teams and demonstrated competence in people management.
- You have experience with IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations and experience authoring sections of regulatory submissions to and responses from regulatory authorities.
- You have Project Management experience, effective communication, ability to overcome obstacles to achieve timely results for products in assigned regions are all necessary skills and experiences.
- Excellent written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators).
- Entrepreneurial, resourceful, energetic and self-starter, you approach challenges with creativity and pragmatism and are able to engage team to achieve goals without direct authority.
- A stimulating scientific position within a high-potential innovative biotech company.
- The opportunity to work in a science-driven, dynamic, human‐sized, respectful and professional environment.
- A challenging scientific and business growth in which you get to bring your knowledge and skills.
- Varied contacts inside the company, the biotech/pharma sector and the scientific world.
- A long-term contract and an attractive salary package in line with the position responsibilities and your experience.
For our recruitments in Belgium, we closely collaborate with a Recruitment & Selection company, PaHRtners. Your application will be automatically forwarded to them. We, together with PaHRtners, will keep all your data confidential (GDPR compliant approach).