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, with a focus on 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 passionate about bringing transformational medicines to patients and excited about working on innovative pharmaceutical products.
The PHAD Specialty Unit is seeking an experienced Drug Product Project Leader (DPPL) to lead drug product development sub-teams, be accountable for the drug product development project strategy, and represent drug product development in the global CMC project team. Apply online using the form below and 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., for Oligonucleotides or RLTs) within the PHAD Specialty Unit.
- Lead and manage all formulation and process development activities for parenteral formulation development and manufacturing.
- Represent drug product project teams in global CMC teams, providing strong quality awareness, scientific expertise, and project management skills.
- Develop a sound drug product project strategy, including contingency planning and risk assessments, in line with the overall Technical R&D project plan and guidelines.
- Monitor project plans to ensure the timely availability of agreed timelines.
- Contribute actively to network deliverables and cross-functional initiatives, promoting collaboration and knowledge sharing.
- Act 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 Lifecycle Management (LCM) projects.
- Actively assess, consolidate, and negotiate resource needs (internal & external costs) and timelines, leading the budgeting process for drug product 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 biopharmaceutical industry experience.
- 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 an advantage.
- Demonstrated scientific leadership skills.
- Basic/advanced skills in Data Analysis and Data Visualization, including the application of data science tools.
- Strong knowledge of relevant GLP, GMP regulations, and policies in parenteral Drug Product development and manufacturing.
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and fostering diverse teams that reflect the patients and communities we serve.
Accessibility and Accommodation
Novartis is dedicated to working with individuals needing reasonable accommodations due to medical conditions or disabilities. If you require assistance or need further clarification about the essential functions of a position, please reach out via email to inclusion.switzerland@novartis.com, including your contact information and the nature of your request. Kindly mention the job requisition number in your message.
Why Novartis
Helping individuals with diseases and their families requires more than innovative science; it demands a community of smart, passionate people. Together, we collaborate, support, and inspire one another to achieve breakthroughs that change patients' lives. Are you ready to create a brighter future together?
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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
Note: Only applications matching the job profile will be considered.