Novartis Pharmaceuticals Fellow, Analytical Project Leader in Fort Worth, Texas
Over 2 billion. This many patients will 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.
Fellow, Analytical Project Leader
What you’ll bring to the role:
•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.
799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Fort Worth, TX
Research & Development
Global Drug Development
TECHNICAL R & D GDD
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.