Drug Product Project Leader (Parenteral Drug Product Development)

Responsibilities

• As Drug Product Project Leader be the strategic lead of 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 parenteral manufacturing.
• Represent DP project teams in global CMC teams, providing strong quality awareness, scientific expertise, and project management skills.
• Develop a sound DP project strategy, including contingency planning and risk assessments, in line with overall Technical R&D project plan and guidelines.
• Monitor project plans and ensures 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.
• Ensures adherence to the EP/ LP project review process and high-quality documentation through relevant governance boards.
• Leads the Transfer Team and clinical development activities in alignment with TDP for late phase and LCM projects.
• Leads and / or contributes actively to respective Network deliverables and cross-functional workstreams/initiatives.
• Assesses, consolidates and negotiates resource needs (internal & external costs) and timelines. Lead 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 (mRNA, siRNA, ASO) or Biologics (ADC, proteins), OR 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.
• Strong scientific leadership skills.
• Basic / Advanced skills in Data Analysis and Data Visualization, including application of data science tools
• Strong knowledge of relevant GLP, GMP regulations and policies requirements in parenteral Drug Product development and manufacturing.

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to E-Mail schreiben and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
 

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