Over 2 billion. This many patients could benefit by therapies driven under the current Ophthalmology portfolio at Novartis. The new Analytical Project Leader will play a major role in leading several of these key projects. Located at the Novartis Technical Research and Development site in Fort Worth, Texas, this Fellow position within the Analytical Research and Development (ARD) group is waiting for you to become part of the Novartis eye care family.
Your responsibilities include, but not limited to:
- Develop and drive overall strategy for analytical development of small molecule drug substances and formulated drug products including solutions, suspensions, emulsions, and other novel dosage forms.
- Lead and manage all analytical activities within a global project team (e.g. characterization of drug substance and drug product, specification setting, method development and validation, stability testing, GLP Tox, and GMP release).
- Accountability to meet quality, timelines, and budget for assigned projects, defining and updating analytical project plans. Communicate with lab scientists, review raw data, perform data integrity checks.
- Conduct quality investigations of deviations, OOS, OOE, etc. Manage global interactions with internal and external stakeholders, including outsourced activities.
- Provide and maintain accurate financial forecasts, including internal resource requirements and external spends. Provide authorship or final review of CMC documents to support regulatory submissions. Represent line unit on global teams.
- Ph.D. in analytical chemistry (or equivalent) with 5+ years of experience in the pharmaceutical industry, preferably in analytical or formulations development.
- Work cross functionally with Quality, Supply Chain, Formulation, Engineering and Validation to ensure an efficient set up of people, assets, tools and equipment in order to best serve business needs consistently and with high quality.
- Make sure that all deliverables are achieved against agreed upon timelines and with committed resources and budget. Ensure that all solutions and products are delivered in compliance with all pertinent corporate and legal guidelines on HSE and quality requirements.
- Coordinate HSE and Quality audits in your responsibility area and ensure that all systems & processes are in compliance and audit readiness is given any time.
- Facilitate and promote a high performance teamwork environment with a culture of empowerment, curiosity, accountability and servant leadership.
- You’ll receive flexible working, learning and development opportunities as well.
- Proven leadership experience in managing projects, ideally in a global matrix environment.
- Strong quality focus, experience in a GMP environment. Profound knowledge of regulatory expectations and analytical development.
- Proven performance in a highly dynamic environment.
- Flexibility to hold off-hours meetings with global partners and key stakeholders.