Formulation Project Leader
vor 2 Monaten
387140BR
**Formulation Project Leader - Oral Dosage Forms (M/F/d) (80-100%*)**:
Switzerland
**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 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.
**Commitment to Diversity & Inclusion**:
- 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).
Accessibility and accommodation
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.
**Division**
Development
**Business Unit**
TECHNICAL R & D GDD
**Work Location**
Basel
**Company/Legal Entity**
Novartis Pharma AG
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
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