CMC Analytical Development Leader - Mechelen,BE or Romainville, FR
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Basel (Switzerland) and in US, Boston.
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you : The ‘make-it-happeners’.
We are looking for CMC Analytical Development Leader.
Scope of the job
The CMC Analytical Development Leader determines the analytical development strategy and leads the analytical development activities within the CMC development team on a project basis. This results in gaining drug substance and drug product understanding, development of the analytical control and stability strategy, and delivery of the necessary source documents to support the Quality dossier (IMPD, NDA, IND and MAA filings).
As Leader Analytical Development within CMC, you will be responsible for the analytical development strategy for drug substance and drug product and execution thereof according to the CMC plan for various development projects.
- being a member of and actively contribute to the various CMC teams assigned to
- analytical method development and validation for drug substance and drug product analysis (non GMP and GMP)
- stability studies and shelf life determination of drug substance and drug product (development and ICH studies), evaluation and characterization of impurities
- specification development and justification thereof for drug substance and drug product
- preparation, review, approval and appropriate storage / archiving of analytical CMC source documents for clinical trial applications (quality section) and preparation of responses to regulatory questions
- selection (in alignment with Head Analytical Development) and management of ESPs executing the analytical development activities
- collaboration (in alignment with CMC team when needed) with internal Quality and Compliance department for project related quality topics
- interaction with other CMC team members to build the CMC development plan and ensure execution thereof
- Adherence to existing Policies and Procedures and ensure timely completion of relevant training.
- Staying abreast of current and new technologies applicable for analytical development and ensuring that the Analytical development strategy remains in line with current regulations and guidelines
Who are you ?
- A master degree or PhD in analytical chemistry or pharmaceutical sciences or bio-engineering or equivalent by experience.
- A minimum of 5 years of experience in drug development, especially in analytical development. Experienced in the preparation of analytical development reports of the Quality dossier (IMPD, NDA, IND and MAA filings).
- Good understanding of the drug development process, pharmaceutical sciences, management of a network of CDMO’s and CRO’s, and working in cross functional teams.
- Strong interpersonal and organizational communication skills, including planning and execution of meetings and presentations.
- Exemplary teamwork and interpersonal skills, organizational and self-management skills.
- Proficiency in all aspects of Microsoft applications (Excel, Word, PowerPoint, Project, etc.)
- Fluently in English both in speaking as in reading and writing.
What’s in it for you ?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos : together we can make it happen…!