CMC Team Lead Job

Job description

CMC Team Lead(Job Number: 00000SGS)DescriptionCrucell, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases.
In our organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.
Crucell Leiden is looking for a fulltime CMC Team LeadDepartment:Vaccine Process and Analytical Development (VPAD) consists of around 250 people located over three different sites (Leiden, Bern and Solna) and is responsible for delivering products to the business to supply clinical trial execution using our patented viral based vaccine technology. VPAD is responsible for process development activities required to deliver manufacturing processes leading to clinical trial materials (CTM), as well as analytical development supporting the monitoring and measurement of product quality attributes leading ultimately to release of material for clinical trials by our quality control and quality assurance group.
Job description:As CMC Leader, you ensure comprehensive planning and program management for VPAD CMC activities linked to overall program strategy. In addition you are responsible for effectively integrating all aspects of process and analytical development, clinical manufacturing and analytical testing required for delivering new vaccine products. You partner with all stakeholders to ensure the appropriate level of technical rigor.1. Management of the Product & Analytical Development (P&AD) activities for one or more specific programs. Including; developing and establishing CMC project strategy, overall CMC program plan, budget, timelines, establishing priorities for CMC program deliverables and aligning these within VPAD and with external stakeholders and relevant governance bodies.2. Lead a matrix CMC team of representatives of the various departments in VPAD.3. Accountable for CMC section of the Product Development Plan and Regulatory submissions.4. Represent the Product & Analytical Development organization and its deliverables in the Compound Development Team (CDT). Responsible for ensuring P&AD project progress, risk & issue management and associated mitigation plans.5. Responsible for overall CMC plan and alignment with global project management department, other CMC Leaders, CDT and functional line departments.6. Responsible for building, coaching and developing CMC teams.
Qualifications
- PhD or equivalent level
- At least 10 years of working experience in the pharmaceutical industry, and at least 5 years experience as CMC lead,
- Experience with vaccines is preferred
- Knowledge of GMP, GLP, GCP, Regulatory processes, Clinical Development or Clinical Operations knowledge as a plus.
Competences:Management & leadership skills, problem solving, communication skills, teambuilder/motivatorThis is a highly complex, visible and interactive job requiring excellent communication skills at all levels, combined with operational independence, deep technical understanding, strategic vision, leadership and organization awareness.
What’s in it for you…?“Caring for the world, one person at a time…”As an employee we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future.
Primary Location:Europe/Middle East/Africa-Netherlands-South Holland-LeidenOrganization: Crucell Holland BV (8852)Job Function: R&D