As a Formulation Project Leader in Oral Late Phase Development (NCE), you will lead and manage formulation and process development of oral solid dosage forms from lab scale through scale-up and transfer to commercial scale. This role requires close collaboration with the Drug Product Subteam. Your development activities will encompass formulation and process design and optimization, quality risk management, as well as scientific writing of development and GMP documentation. A keen interest and experience in applied data science and mechanistic modeling will be pivotal in enabling data-driven and efficient process development and scale-up.
About the Role
Your responsibilities will include but are not limited to:
You have a passion for innovative formulations and technologies, backed by experience in enabling formulation development.
You understand the significance of data-centric, computational models and bring experience applying them to guide formulation and manufacturing process development.
You will drive the formulation development and manufacturing work of standard and enabling oral drug products (NCE) with scientific excellence, supported by data-driven conclusions and mechanistic modeling.
You will closely collaborate with the Drug Product Sub-Team and Transfer Team members to identify, understand, and manage critical aspects concerning Drug Substance, Drug Product, Analytics, Packaging, and Device.
You will maintain regular communication with key experts in various fields including Technology Focus Groups, Modelling & Simulation, and Biopharmaceutics to incorporate their insights into the development strategy and project plans.
You will author scientifically sound and well-structured development and GMP documentation to facilitate the commercial manufacturing of new Drug Products.
You will contribute to the generation of CMC submission dossiers and support inquiries from Health Authorities and Inspectors regarding Drug Product-related questions.
What You'll Bring to the Role:
Advanced degree (minimum PhD) in a relevant scientific field (e.g., Pharmaceutical Technology, Chemical Engineering).
A minimum of 2 years of successful industry experience in the development of pharmaceutical formulations, focusing on formulation and process development for small molecules (NCE) and the scale-up of manufacturing processes into oral drug products for commercialization.
Knowledge of data science and data visualization, with experience applying data-centric, computational models to guide formulation and manufacturing process development.
Interdisciplinary thinking and a strong interest in collaboration with other functions.
A broad and profound understanding of formulation development activities.
Proficient knowledge of laboratory and technical tools (e.g., QbD, PAT) as well as familiarity with relevant GLP and GMP regulations and policies.
A demonstrated track record of creativity and problem-solving in projects.
Effective communication, organizational, planning, and negotiation skills.
Strong scientific and technical writing skills.
Commitment to Diversity and Inclusion
Novartis is dedicated to creating an outstanding, inclusive work environment and building diverse teams that reflect the patients and communities we serve.
Accessibility and Accommodation
Novartis is committed to accommodating individuals with medical conditions or disabilities as required. If you need reasonable accommodations during the recruitment process or to receive more detailed information about the essential functions of a position, please send an email to Show e-mailm"> and include the job requisition number in your message.
Why Novartis
Helping people with diseases and their families goes beyond innovative science; it requires a community of smart, passionate individuals like you. Together, we collaborate, support, and inspire each other, striving for breakthroughs that significantly impact patients' lives. Are you ready to create a brighter future together? Learn more here.
Join Our Novartis Network
If this is not the right role for you, consider signing up for our talent community. Stay connected and learn about suitable career opportunities as soon as they arise: Join here.
Benefits and Rewards
Discover all the ways we help you thrive personally and professionally by reading our benefits handbook: Read more.
Application Process
Apply online using the form below. Please note that only applications matching the job profile will be considered.
Division
Development
Business Unit
Innovative Medicines
Location
Switzerland
Site
Basel (City)
Company / Legal Entity
C028 (FCRS = CH028) Novartis Pharma AG
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams that reflect the patients and communities we serve.