Drug Product Project Leader / Drug Product Project Leaderess
Novartis Pharma AG - June 20, 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 innovative parenteral medicines, particularly in xRNA therapeutics and radioligand therapies (RLT). This role presents an exciting opportunity to advance the technology platform for both xRNA and RLTs while contributing to the development of patient-centric drugs. We are looking for someone passionate about transforming medicine and eager to work on groundbreaking pharmaceutical products.
The PHAD Specialty Unit seeks an experienced Drug Product Project Leader (DPPL) to lead drug product development sub-teams, oversee the DP development project strategy, and represent DP development in the global CMC project team. Apply online using the form below and become part of a team dedicated to 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 while providing strong quality awareness, scientific expertise, and project management skills.
Develop a robust DP project strategy, including contingency planning and risk assessments, aligned with the overall Technical R&D project plan and guidelines.
Monitor project plans and ensure the timely availability of agreed timelines.
Actively contribute to network deliverables and cross-functional initiatives, promoting collaboration and knowledge sharing.
Serve as an author, reviewer, or approver for 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.
Actively lead or contribute to respective Network deliverables and cross-functional workstreams/initiatives.
Assess, consolidate, and negotiate resource needs (internal & external costs) and timelines while leading the budgeting process for DP activities.
Requirements
Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Technology, or related disciplines with 7+ years of experience in parenteral drug product development, specifically for Oligonucleotides (mRNA, siRNA, ASO) or Biologics (e.g., ADC, proteins); or a Master's degree with 9+ years of experience in the biopharmaceutical industry.
Broad and profound understanding of development activities and processes in pharmaceutical sciences (parenteral, aseptic, solution, and/or suspension).
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 advantageous.
Strong scientific leadership skills.
Basic to advanced skills in data analysis and data visualization, including the application of data science tools.
Strong understanding of relevant GLP and GMP regulations and policies in parenteral drug product development and manufacturing.
Commitment to Diversity and Inclusion
Novartis is dedicated to creating an outstanding, inclusive work environment and diverse teams that reflect the patients and communities we serve.
Accessibility and Accommodation
Novartis is committed to providing reasonable accommodations to all individuals. If you require assistance during any part of the recruitment process due to a medical condition or disability, or if you need detailed information about the essential functions of a position, please contact us at Show e-mailm">, including the job requisition number in your message.
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