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) to oversee drug product formulation and process development for innovative parenteral medicines, including xRNA therapeutics and radioligand therapies (RLT). This role is designed for individuals who are passionate about delivering transformational medicines and working with groundbreaking pharmaceutical products.
The PHAD Specialty Unit is looking for an experienced Drug Product Project Leader (DPPL) to spearhead DP development sub-teams, manage the DP development project strategy, and represent DP development on the global CMC project team. Apply online using the form below to join 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 formulations and manufacturing.
- Represent DP project teams in global CMC teams, providing quality awareness, scientific expertise, and project management skills.
- Develop a comprehensive DP project strategy, including contingency planning and risk assessments, in line with the overall Technical R&D project plan.
- Monitor project timelines and ensure timely availability of agreed milestones.
- Actively contribute to network deliverables and cross-functional initiatives to promote collaboration and knowledge sharing.
- Author, review, or approve documents associated with PHAD, 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 coordinate clinical development activities for late-phase and LCM projects.
- 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 industry experience in parenteral drug product development (e.g., for Oligonucleotides or Biologics), OR a Master's degree with 9+ years of experience in the biopharmaceutical industry.
- Extensive understanding of development activities and processes in pharmaceutical sciences (parenteral, aseptic, solution, and/or suspension).
- Proficient in 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 a plus.
- Strong scientific leadership and data analysis skills, including data visualization and application of data science tools.
- Comprehensive knowledge of relevant GLP and GMP regulations and policies pertaining to parenteral drug product development and manufacturing.
Commitment to Diversity and Inclusion
Novartis is devoted to fostering an inclusive work environment and cultivating 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 due to a medical condition or disability during the recruitment process, please contact us at inclusion.switzerland@novartis.com, including the job requisition number in your message.
Why Novartis
Helping individuals battling diseases and supporting their families involves more than innovative science; it requires a community of dedicated and passionate individuals. Join us in collaborating, supporting, and inspiring one another to achieve breakthroughs that transform the lives of patients.
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Benefits and Rewards
Discover how we support your personal and professional growth by exploring our benefits handbook: Learn About Benefits and Rewards.
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