we are looking for an experienced R&D Manager - pharmaceutical development & cmc to lead our pharmaceutical and analytical r&d activities, from product and technology evaluation through pharmaceutical development, scale-up, technology transfer, regulatory submission, product launch, and transfer to routine commercial manufacturing for the us and eu markets.
the role includes overall responsibility for development programs, timelines, resources, and budgets, as well as the professional and managerial leadership of r&d teams. the position requires close collaboration with key functions across the organization and with external partners.
key responsibilities:
lead the development of new pharmaceutical products and the implementation of in-licensed products and external development or technology-transfer packages for the israeli, us, and eu markets.
provide professional and managerial leadership across pharmaceutical and analytical r&d activities.
develop and execute annual and multi-year r&d plans, including budgets, resources, priorities, and timelines.
lead formulation and process development activities, including quality by design (qbd), scale-up, registration batches, and technology transfer.
lead the transfer of products from development to routine commercial manufacturing.
provide scientific and technical leadership for troubleshooting, deviation investigations, process validation, and manufacturing process improvement.
work closely with QA, QC, regulatory affairs, production, engineering, procurement, business development, and external development and manufacturing partners.
support the preparation and review of cmc and regulatory submission documentation, specifications, protocols, stability programs, and manufacturing documentation.
participate in the scientific and technical evaluation of products, technologies, and external development or technology-transfer packages as part of business development and due diligence activities.
lead, manage, develop, and mentor employees, including recruitment, training, performance management, and professional development.
דרישות:
requirements:
an advanced degree is required: m.sc., pharm.d., ph.d., or an advanced management degree (such as an mba) combined with a relevant scientific or engineering degree in chemical or biotechnology engineering, chemistry, pharmacy, or a related field.
at least seven years of proven experiencein pharmaceutical product development/cmc, including scale-up, technology transfer, registration activities, and transfer of products from development to commercial manufacturing for the us and/or eu markets - must.
significant experience in pharmaceutical manufacturing processes, including substantial experience in at least one of the following areas: sterile/aseptic products or solid oral dosage forms (tablets/capsules), together with good working knowledge of the other area - must.
experience on both dosage-form platforms is a significant advantage.
strong knowledge of and experience in a gmp-regulated pharmaceutical environment - must.
significant managerial experience and demonstrated success in leading scientific and technical teams within the pharmaceutical industry - must.
hands-on experience supporting fda submissions for drug-device combination products, including cmc and device-development interfaces - significant advantage.
experience in analytical development and analytical method validation - significant advantage.
strong project and portfolio management capabilities, including prioritization, resource planning,budget management, and on-time delivery.
excellent english, both written and spoken, including strong scientific and professional writing and presentation skills.
excellent problem-solving and troubleshooting capabilities, with strong scientific judgment and creative approaches to resolving complex development and manufacturing challenges.
strong decision-making and delegation skills, with a proactive, results-orie המשרה מיועדת לנשים ולגברים כאחד.