We are currently looking for a talented, energetic and ambitious CSO. The successful candidate must have proven experience with the US market, a deep understanding of CMC and have a strong scientific profile. The candidate must have long and extensive experience with the product development process and the regulatory requirements allowing successful registration with the authorities. Given that most of the new developments are targeted for the USA, strong experience with FDA requirements will be a strong asset.
As a candidate, you are an expert with robust and recent knowledge in the field of liquid/injectable Generic product development for the USA (ANDA and 505(b)(2). You have been part of a successful medium sized pharmaceutical company.
The job description
As CSO you will:
• Provide scientific advice to the Management Team, the CEO and the Board to support the strategy of Hyloris.
• Steer, manage and develop the product development programs and oversee the performance of development activities from R&D handover to regulatory approval for US and EU projects.
• Lead, manage and develop the R&D teams in the corporate offices and the development laboratory.
Your professional profile
• Minimum Qualification: Scientific degree, level of Ph.D. or higher.
• Minimum Experience: Minimum 15 years of experience with drug product development for the USA in the fields of formulation, manufacturing process and/or analytical method development of conventional chemical medicines, mainly in the field of injectable.
• Languages: English. French or Dutch is an asset.
• Strong skills in chemistry and drug product formulation as well as robust knowledge of manufacturing facilities, manufacturing technologies and equipment, their suitability and limitations.
• Strong analytical skills, good negotiator/diplomat, enabler.
• Strong interpersonal skills, a collaborative and trust enabling working style, building partnerships among key stakeholders.
• Exposure and familiarity with FDA processes and requirements for 505b2 NDA submissions including pre-IND submissions, IND and clinical matters.
• Organizational aptitude to build, lead and develop an outstanding team.
• Adaptability, flexibility, independence and resourcefulness to both lead a big vision strategy while also willing to roll-up-sleeves and multi-task in order to thrive in a growing environment.
ABOUT OUR COMPANY
Hyloris is a virtual company focusing on launching added-value products in the US. The headquarter is in Liege, Belgium, but we have people based in the US also..
Hyloris has a robust management team with a success track record from many years in the pharmaceutical industry. We have a full operational structure with departments for Business Development, R&D, Regulatory, Medical Affairs and Licensing. Operations are currently outsourced.
Our talented staff work in accordance with our company values:
• We are proud of our entrepreneurial culture and foster open communication, mutual respect, professionalism and efficient decision-making and we believe that our multicultural organisation is one of our most important competitive advantages.
• We believe that timely and well considered decisions as a response to emerging opportunities and ideas is the key to our success.
• We believe that the success of the company lies in the competence, dedication and motivation of each of our employees.
• We believe that freedom returns flexibility and empowerment returns commitment.
ABOUT OUR R&D DEPARTMENT
Our R&D department consist of 2 employees, working in both our Belgian office and from the US. We are however recruiting aggressively for another 3 positions and expect the department to grow to a minimum of 10 people within the next 12-18 months. We work on an exciting pipeline of more than 15 value added products and are focused on adding more projects to our pipeline. We are working with development canters and contract manufacturers World-wide.