Company: Nestle Location: Piscataway, NJ Employment Type: Full Time Date Posted: 09/15/2020 Expire Date: 10/07/2020 Job Categories:
Healthcare, Practitioner and Technician, Manufacturing and Production, Executive Management, Research & Development, Medical
R&D Drug Project Lead
Nestlé Health Science invests in every employee to make certain each person can reach their greatest potential and works in an environment rooted in respect, diversity and teamwork. We focus on empowering the patients and consumers we serve to live healthier lives through industry leading nutrition and nutrition-enabling solutions by keeping their needs at the center of everything we do. We make quality and innovation our highest priorities when delivering our trusted brands such as BOOST®, Carnation Breakfast Essential®, Peptamen®, Compleat Organic Blends®, Zenpep®, and many more.
We are a globally recognized leader in the field of nutrition science with our US headquarters in Bridgewater, NJ, and have over 5000 employees around the world. Come join the Nestlé Health Science family and experience exciting opportunities!
Position Overview: As an R&D (Research and Development) Drug Project Leader, you will lead multi-disciplinary R&D work streams for internal innovative Rx drug developments including CMC (Chemistry/Manufacturing/Controls), pre-clinical and clinical development. In addition, you will oversee the R&D work streams for external drug developments. You will serve as liaison and critical issue point for the project/program.
Key responsibilities: • Develop drug development project plan (incl. budget) in close cooperation with Scientific Medical Organization (SMO) Leadership team • Leading cross-functional program activities for drug projects • Handle CMC life-cycle management and product development for a drug through clinical development (Drug Substance and Drug Product) • Plans, establishes, leads, monitors and performs activities related to clinical supplies, to support the drug development process (Phase I-IV), in cooperation with internal and external customers and partners in compliance with multinational regulations as well as NHSc internal procedures and GxP requirements. • Coordinate with functional leads/line managers from Process Development, Manufacturing, Quality, IMP, Clinical Development, Clinical Operations and Regulatory Affairs and external consultants to ensure timely execution of work packages • Participation to the preparation of CMC submission dossiers to Health Authorities • Run product disposition and inventory • Point of contact for technical leads/line managers at both CMO/CRO, Nestlé Health Science, Vitaflo as well as external consultants • Lead planning, prioritization and tactical steps in daily operations required to accomplish project goals • Identify and communicate resource and capability needs (internal and external) to ascertain project goals • Implement and lead most effective project management practices across project teams. Use state-of-the art project management and documentation tools • Ascertain executional excellence of the project aligning with internal and external quality standards (GMP, GLP, and GCP; state-of-the-art data management) • Effective communication and presentation of project status, issues, and risks to Executive Teams • Assume the role of Alliance Manager with external partners on behalf of NHSc
Qualifications & Requirements
Required Profile At minimum 8-10 years Rx drug development experience in the following areas: • CMC development. • Preclinical and clinical development strategies • IP protection strategies • R&D budget for project/portfolio management. • Previous experience in biological drugs development is a strong asset. • Familiar with FDA, EU, and international drug development regulations. • Consolidated project manager skills: • Cross-functional project team coordination • Strong project management skills (stage-gate project management / E2E) • Tracking and communication of key project achievements, risks, and issues (partner concern of issues if needed) • Interactions with external specialists • Data management