Drug Product Project Leader / Drug Product Project Leaderess
Novartis Pharma AG - June 1, 2025
Job ID
REQ-10051450
Date: May 12, 2025
Location: Basel, Switzerland
Summary
Join the Pharmaceutical Development (PHAD) Specialty Unit as an Associate Director - Drug Product Project Leader (DPPL) in the formulation and process development of innovative parenteral medicines, particularly xRNA therapeutics and radioligand therapies (RLT). This is an excellent opportunity for someone who is passionate about delivering transformational medicines and working on groundbreaking pharmaceutical products.
The PHAD Specialty Unit is seeking an experienced Drug Product Project Leader to take charge of drug product development sub-teams, ensuring accountability for DP development project strategies, and representing DP development in global CMC project teams. Join us in revolutionizing drug product development.
About the Role
Responsibilities
Lead complex Drug Product Development projects (e.g., for Oligonucleotides or RLTs) within the PHAD Specialty Unit.
Manage all formulation and process development activities for parenteral formulation development and manufacturing.
Serve as a representative for DP project teams in global CMC teams, showcasing quality awareness, scientific expertise, and project management capabilities.
Develop a comprehensive DP project strategy, including contingency planning and risk assessments, aligned with the overall Technical R&D project plan and guidelines.
Monitor project plans to ensure adherence to established timelines.
Actively contribute to network deliverables and cross-functional initiatives while promoting collaboration and knowledge sharing.
Author, review, or approve PHAD-owned documents while supporting submission writing and addressing inspection requirements.
Ensure compliance with EP/LP project review processes 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 projects.
Assess, consolidate, and negotiate resource needs, timelines, and lead budgeting processes for DP activities.
Requirements
Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Technology, or related disciplines with over 7 years of industry experience in parenteral drug product development, OR a Master's degree with a minimum of 9 years of biopharmaceutical industry experience.
In-depth understanding of development activities and processes in pharmaceutical sciences (parenteral, aseptic, solution, and/or suspension).
Strong knowledge of laboratory and technical tools (e.g., Quality by Design, statistical software, Process Analytical Technology).
Familiarity with medical devices such as pre-filling syringes, vials, and combination products is a plus.
Exceptional scientific leadership and communication skills.
Strong analytical and visualization skills, including experience with data science tools.
Comprehensive knowledge of relevant GLP, GMP regulations, and policies in parenteral drug product development and manufacturing.
Commitment to Diversity and Inclusion
Novartis is dedicated to creating an exceptional, inclusive working environment with diverse teams that represent the patients and communities we serve.
Accessibility and Accommodation
Novartis is committed to offering reasonable accommodations to all individuals. If you require a reasonable accommodation during the recruitment process due to a medical condition or disability, please email Show e-mailm"> with the nature of your request and your contact information. Please include the job requisition number in your message.
Why Novartis
Helping patients and their families demands more than innovative science; it requires a community of smart, passionate individuals. Here at Novartis, we believe in collaborating, supporting, and inspiring each other to achieve breakthroughs that change lives. Ready to create a brighter future together?
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Additional Information
Division: Development
Business Unit: Innovative Medicines
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
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