Would you like to receive the latest vacancies in your e-mail box? Create a job alert based on your keyword(s) and preferences.
Head of LentiViral CMC and Manufacturing
For the CellPoint/Galapagos organisation in Leiden/NL, we are looking for an Head of LentiViral CMC and Manufacturing - Leiden,NL
In this role you will lead the CellPoint LVV/ADV CMC Development and External Manufacturing, reporting to the CEO of CellPoint.
You will play a pivotal role within the organization and will be passionate about CMC development as well as the management of external partnerships. The scope of these partnerships includes contract development and manufacturing organizations (CMO/CDMO), Contract Testing Labs (CTLs) and the scientific and technical leadership for all technologies to transfect or transduct primary human cells, with a first focus on the Lentiviral Vector supply for our CAR-T programs.
You will oversee the CDMO relationships and align with CellPoint / Galapagos executives on the LVV strategy of the company; setting scientific and technical direction for LVV Process Development, Analytical Development and GMP operations; driving multiple projects forward including the timely delivery of relevant IND / MAA / BLA sections; critical issue/risk identification, partner concern assessment and driving resolution; performance monitoring; and assuring critical material and product supply.
You have strong leadership skills (career development and mentor), technical skills (biologics/gene and cell therapy manufacturing and testing operations, GMP regulation and drug development life cycle), strategic, network-based thinking (tact, contract negotiation, project management) and financial acumen (financial analysis).
Summary of Key Responsibilities:
• Acting as the leader for the LVV (or similar) programs, lead negotiations with partners and ensuring effective cross-functional coordination
• Selecting best-suited partners to meet CellPoint's’ strategic objectives and establishing the required supply and quality agreements, onboarding and tech transfer plan for each partner
• Providing executive level mentorship and support to strategic & top tier partners
• Ensuring each partner is receiving adequate support & resources from cross-functional team and hold functions accountable for meeting "service level agreements"
• Approving operational roadmap, annual plans, prioritization of funding & personnel requirements, and partner KPIs
• Execution of operational activities with CMOs/CTLs/Partners to ensure robust and timely supply of viral vector(s)
• Planning/execution of process changes/improvements at CMO/CTL/Partner sites considering regulatory and jurisdictional control of implications within the supply chain network
• Approving risk mitigation strategies, & major technical issue resolution, and endorsing plans for continuous improvement / OE programs
• Resolving issues and raising as appropriate
• Developing the required team and organization to meet the needs of a growing portfolio and evolve from an early development into a late development organization in a timely manner
• Up to 40% travel (both domestic and international)
• MA / MS or PhD degree with 10-15 years’ experience working in global organizations
• Knowledge and direct experience in developing technology and methods for the manufacture, characterization and release of LVV and/or AAV used in cellular therapeutics
• CMC team experience. Demonstrated knowledge of control strategy for CMC programs and all regulatory requirements relevant for cell & gene therapy, and viral vectors used in cell & gene therapy
• Knowledge and experience with lentiviral and AAV biology; Ideally also experience with engineered T cells using viral gene delivery modalities.
• Track record of successful external technical collaborations with CDMOs
• Proven ability to work in a fast-paced environment, meet deadlines and prioritize work on multiple projects. Ability to handle multiple responsibilities simultaneously
• Hands-on inspiring leader, who delegates but is also willing to roll up sleeves to get the job done
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 CellPoint/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, you will join 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.
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company. We’re in the business of changing lives.
Galapagos’ mission is to make a lasting positive contribution to society through discovery of innovative therapies for diseases with large unmet medical need. Galapagos seeks to develop a robust portfolio of therapies that have the potential to revolutionize existing treatment paradigms. The company’s ambition is to become a leading global biopharmaceutical company, focused on the discovery, development and commercialization of innovative medicines to improve patients’ lives. Galapagos’ historic focus on developing first-in-class medicines based on the discovery of novel targets in inflammation and fibrosis has led to the successful launch of our first medicine in rheumatoid arthritis in 2020 and in ulcerative colitis in 2021. The pivotal study in Crohn’s Disease is fully recruited and we expect topline data and potential approval in this new indication in a couple of years.
Galapagos is now entering an exciting new chapter to expand and diversify its pipeline for the future, starting with oncology, specifically CAR-T cell-therapy, a transformative treatment of different types of cancer. Through the combined acquisitions of CellPoint and AboundBio, we are propelling ourselves into next-generation cell therapies. CellPoint brings a novel, decentralized point-of-care cell therapy manufacturing model, which has the potential to offer efficient, 7-day time to treatment and avoids complex logistics, resulting in potential better patient outcomes and broader access.