Drug Product Project Leader / Drug Product Project Leaderess
Novartis Pharma AG - June 8, 2025
Job ID
REQ-10051450
May 12, 2025
Switzerland
Summary
Location: Basel, Switzerland
Role Purpose: Join the Pharmaceutical Development (PHAD) Specialty Unit as an Associate Director - Drug Product Project Leader (DPPL) for drug product formulation and process development of parenteral innovative medicines, especially xRNA therapeutics and radioligand therapies (RLT). Advance the technology platform for both xRNA and RLTs and contribute to the development of patient-centric drugs. This position is ideal for individuals who are passionate about transforming patient care through exciting novel pharmaceutical products.
The PHAD Specialty Unit is seeking an experienced Drug Product Project Leader (DPPL) to lead development sub-teams, oversee the project strategy, and represent DP development in the global CMC project team. Apply online using the form below to be part of a team that is revolutionizing drug product development.
About the Role
Responsibilities
Serve as the strategic lead for complex Drug Product Development projects (e.g., Oligonucleotides or RLTs) within the PHAD Specialty Unit.
Lead and manage all formulation and process development activities for parenteral formulation development and manufacturing.
Represent DP project teams in global CMC teams, demonstrating strong quality awareness, scientific expertise, and project management skills.
Develop a robust DP project strategy, including contingency planning and risk assessments, aligning with overall Technical R&D project plan and guidelines.
Monitor project plans and ensure timely availability of agreed timelines.
Actively contribute to network deliverables and cross-functional initiatives, promoting collaboration and knowledge sharing.
Draft, review, or approve PHAD-owned documents, supporting submission writing and addressing inspection requirements.
Ensure adherence to the EP/LP project review process and maintain high-quality documentation through relevant governance boards.
Lead the Transfer Team and clinical development activities in alignment with TDP for late-phase and LCM projects.
Assess, consolidate, and negotiate resource needs (internal & external costs) and timelines. Lead the budgeting process for DP activities.
Requirements
Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Technology, or related disciplines with 7+ years of industry experience in parenteral drug product development (e.g., Oligonucleotides or Biologics), or a Master's degree with 9+ years of relevant experience.
Broad and profound understanding of development activities and processes in pharmaceutical sciences, particularly in parenteral, aseptic, solution, and/or suspension formulations.
Strong knowledge of laboratory and/or technical tools (e.g., Quality by Design, statistical software, Process Analytical Technology).
Familiarity with devices such as pre-filling syringes, vials, and combination products is beneficial.
Strong scientific leadership skills.
Basic to advanced skills in Data Analysis and Visualization, including the application of data science tools.
Solid knowledge of relevant GLP and GMP regulations and policy requirements in parenteral drug product development and manufacturing.
Commitment to Diversity and Inclusion
Novartis is committed to fostering an outstanding, inclusive work environment and building diverse teams that reflect the patients and communities we serve.
Accessibility and Accommodation
If you require reasonable accommodation during the recruitment process due to a medical condition or disability or need more detailed information about the essential functions of a position, please send an email to Show e-mailm">. Include your request and contact information, along with the job requisition number.
Why Novartis
Helping people with disease and their families requires not just innovative science but a community of smart, passionate individuals like you. Together, we collaborate, support, and inspire one another to achieve breakthroughs that transform patient lives. Ready to create a brighter future together? Learn more about us.
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Benefits and Rewards
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Division
Development
Business Unit
Universal Hierarchy Node
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
Application Information
Apply online using the form below. Please note that only applications matching the job profile will be considered.