About the Role

　　Location: Basel, Switzerland

　　Job Purpose:

　　Novartis holds a rich development portfolio of small molecules ready to develop into innovative patient centric oral dosage forms. As a Formulation Project Leader working on oral dosage forms, you will lead and run all formulation and manufacturing activities linked to pharmaceutical development for oral dosage forms for small molecules (New Chemical Entities; NCE).

　　The focus of that role is to define and develop formulations and processes suitable for initial first-in-human trials until scale-up and transfer to enable commercial manufacturing of our future Drug Products and in particular for "enabling" formulations.

　　Your responsibilities will include but are not limited to:

　　• You are accountable for all formulation and manufacturing process deliverables incl. scientific documentation and excipient qualification for all assigned projects.

　　• You have a passion for innovative formulation and process development approached, including applying modeling and advanced digital skills.

　　• You create, own and update formulation project plans aligned with the control strategy being in line with the overall Drug Product (DP), TRD project plan, and internal guidance.

　　• You drive DP development and supply activities with scientific and technological excellence. You closely collaborate with Drug Product sub-team members. You understand, identify and manage with them together critical aspects around DS, DP, packaging and analytics.

　　• You drive regular exchange with Biopharmaceutics Experts to understand critical factors for absorption and DP-performance and build this understanding into your development strategy.

　　• You ensure authoring of accurate, comprehensible, structured, complete and legible development reports and "Supply documents" to allow timely start of development trials, process transfers and supply activities.

　　• You contribute to the generation of filing dossiers, answer DP related questions in inspections and support Health Authority requests.

　　• You have a passion for innovative formulation and process development approached, including applying modeling advanced digital skills

　　Diversity & Inclusion / EEO

　　We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

　　Role Requirements

　　What you'll bring to the role:

　　• Advanced degree in relevant scientific field (i.e. minimum PhD)

　　• Minimum 2-4 years of successful industry experience in the development of pharmaceutical formulations in a matrix organization. Focus: Formulation development (small molecules NCE) and scale up of manufacturing processes into oral drug products for commercialization

　　• Desired: Good knowledge of Data science, Data visualization and use of programming language such as Python. Experience with developing formulations for oral delivery of molecules having permeability challenges (including small molecules, peptides, proteins)

　　• Interdisciplinary thinking and curiosity about collaboration with other functions

　　• Broad and profound understanding of formulation and process development activities.

　　• Good knowledge of laboratory and/or technical tools (e.g. QbD, PAT) as well as knowledge of relevant GxP regulations and policies

　　• Successfully demonstrated track record of creativity and problem solving in projects.

　　• Good interpersonal skills, organizational, planning and negotiation skills (German language skills desired).

　　Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

　　You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

　　Accessibility and accommodation

　　Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

　　Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

　　Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

　　Division

　　Development

　　Business Unit

　　TECHNICAL R & D GDD

　　Location

　　Switzerland

　　Site

　　Basel

　　Company / Legal Entity

　　Novartis Pharma AG

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No