
51 - 200 Mitarbeiter
🏥 Gesundheitswesen
🧬 Biotechnologie
💊 Pharmazie
Healthcare • Biotechnology • Pharmaceuticals
Celcuity ist ein Biotechnologieunternehmen in der klinischen Entwicklungsphase, das zielgerichtete Therapien entwickelt, die den PI3K/AKT/mTOR (PAM)-Weg blockieren, um mehrere solide Tumore zu behandeln. Sein führender Kandidat, Gedatolisib, ist ein potenzieller erstklassiger Pan-PI3K und mTORC1/2-Inhibitor, der in Studien zu Brust- und Prostatakrebs untersucht wird. Das Unternehmen verfolgt ein fokussiertes Entwicklungsprogramm mit dem Ziel, transformative, zielgerichtete Krebstherapien bereitzustellen, und führt klinische Entwicklungs- sowie datengetriebene Forschungsarbeiten durch, um regulatorische und medizinische Akzeptanz zu unterstützen.
🕒 vor 3 Tagen
🗣️🇺🇸🇬🇧 Englisch erforderlich
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51 - 200 Mitarbeiter
🏥 Gesundheitswesen
🧬 Biotechnologie
💊 Pharmazie
Healthcare • Biotechnology • Pharmaceuticals
Celcuity ist ein Biotechnologieunternehmen in der klinischen Entwicklungsphase, das zielgerichtete Therapien entwickelt, die den PI3K/AKT/mTOR (PAM)-Weg blockieren, um mehrere solide Tumore zu behandeln. Sein führender Kandidat, Gedatolisib, ist ein potenzieller erstklassiger Pan-PI3K und mTORC1/2-Inhibitor, der in Studien zu Brust- und Prostatakrebs untersucht wird. Das Unternehmen verfolgt ein fokussiertes Entwicklungsprogramm mit dem Ziel, transformative, zielgerichtete Krebstherapien bereitzustellen, und führt klinische Entwicklungs- sowie datengetriebene Forschungsarbeiten durch, um regulatorische und medizinische Akzeptanz zu unterstützen.
• Support establishment and management of a robust, effective global supply chain for commercial supply of gedatolisib and future pipeline programs • Support development and maintenance of processes ensuring continuous commercial supply while maintaining regulatory and quality compliance • Support production planning, global logistics and warehousing, global supply chain procurement, planning and sourcing, demand management, end-to-end inventory strategy and materials management • Support global trade compliance, security and integrity, and packaging activities • Support development and implementation of standard business processes, including quality-related activities, for new product launches • Support business integrations and subsequent supply operations internally and at CMO partners
• Bachelor’s degree • 8 years’ experience in the pharmaceutical industry • At least 5 years’ work experience in a commercial supply setting, preferably in international markets • MBA or other advanced degree focused on Supply Chain Management is a plus • APICS Certified Supply Chain Professional certification is a plus • Demonstrated experience with oversight of external supply chain partners • Strong experience with regulatory requirements and inspections for commercial products • Demonstrated experience with pre-launch and commercial launch activities of a new ethical drug, including production planning, system design and implementation • Proven record of accomplishment in GMP/GDP pharmaceutical or biotech supply chain operations • Experience with new product launch and/or establishment of supply chain for new markets, including selection and integration of new external manufacturing and commercial partners • Knowledge of DSCSA requirements is a plus • Experience designing and deploying new business processes and supply chain management systems, including Supply Chain Quality, ERP, S&OP, and demand management • Strong team leadership and change management experience for routine market supply and market expansion • Strong quality and compliance background • Work history in a virtual or semi-virtual pharmaceutical company • Leadership and interpersonal skills, including a collaborative and team-oriented approach • Excellent verbal and written communication skills • Detail-oriented personality and ability to work and drive change across functions • Good organizational, time management, computer, and software skills • Ability to learn and implement new techniques, technologies, and novel approaches • Ability to quickly react to and mitigate unforeseen challenges • Ability to build strong relationships with co-workers of various backgrounds and expertise • Ability to function at a high level in a team setting, whether leading the group or acting as an individual contributor
• Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays
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