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PHAD PDU Oral Drug Product Project Leader

Job in 4040, Basel, Kanton Basel-Landschaft, Switzerland
Listing for: Novartis AG
Full Time position
Listed on 2026-10-27
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist
  • Management
    Regulatory Compliance Specialist, Project & Program Management
Salary/Wage Range or Industry Benchmark: 94000 - 174000 CHF Yearly CHF 94000.00 174000.00 YEAR
Job Description & How to Apply Below

Job

REQ-

Oct 09, 2026

Switzerland

Summary

Location:

Basel, Switzerland #onsite

Role

Purpose:

We are looking for a collaborative and scientifically strong professional to take on the role of Drug Product Project Leader (DPPL) across late-phase oral drug product development programs. In this role, you will lead Drug Product technical development activities for assigned projects, ensuring scientific excellence, strong quality awareness, and alignment with overall project objectives.
The role includes developing and implementing robust Drug Product project strategies, including risk assessments, contingency planning, timelines, budgets, and resource plans. It also requires ensuring alignment with internal functions, external partners, governance processes, and project review milestones.
As DPPL, you will lead, coach, and develop high-performing project teams in line with company values and behaviors. The role is expected to foster a collaborative culture, promote knowledge sharing, set clear objectives, and support the growth and performance of team members.
The position will oversee project execution, proactively manage cross-functional interfaces, and communicate project strategy, risks, issues, and critical updates to relevant stakeholders.
Key responsibilities include ensuring high-quality development documentation and contributing to CMC submission packages, filing dossiers, inspection responses, and Health Authority requests. The role also includes acting as author, reviewer, or approver of development documents in accordance with applicable SOPs and development standards.
In addition, the DPPL will drive Make versus Buy strategies and support outsourced activities with external partners, including input into contracts, quality agreements, and third-party supply-related projects.

About the Role

Your responsibilities will include but are not limited to:

  • Represent DP project teams within TRD sub-teams, providing strong quality awareness, scientific expertise, and technical leadership.
  • Develop robust DP project strategies, including contingency planning and risk assessments, while ensuring alignment with internal functions, external partners, and third parties
  • Assess, consolidate, and negotiate project resources, timelines, internal and external costs, and lead the budgeting process for DP activities.
  • Ensure adherence to project review processes and relevant governance boards, while implementing building on scientific excellence and approved DP strategies within the project team.
  • Proactively manage cross-functional project interactions, monitor project plans, ensure timely delivery of key outputs, and oversee high-quality DP development documentation for CMC submissions.
  • Understand and integrate scientific insight into how drug substanceandexcipientproperties, formulation design, and process parameters influence product performance, manufacturability, and consistency.
  • Support and apply structured, science-based approaches (e.g., quality-by-design, modelling, and digital tools) to enhance understanding, enable informed decision-making, and support consistent and efficient development practices
  • Lead, manage, coach, and support DP teams in line with company values and behaviours, fostering collaboration, team spirit, knowledge sharing, and high performance.

What you-ll bring to the role:

  • Advanced degree in Pharmaceutical Technology, Powder Process Engineering, or a related scientific field;
    PhD or equivalent experience is valued.

  • Minimum 5+ years of relevant industry experience in the development of pharmaceutical formulations, preferably with broad and profound understanding of development activities and processes in pharmaceutical sciences. (early and late phase development of oral dosage forms).

  • Solid understanding of Quality by Design (QbD), regulatory guidelines (ICHQ8, 9 and 10) and biopharmaceutics, with ability to build compliant bridging strategies. Broad and profound understanding of development activities and processes in pharmaceutical sciences. (early and late phase development).

  • Excellent leadership, scientific, project management and presentation skills, with the ability to convey complex topics clearly and contribute to efficient and aligned teamwork.

  • Ability to balance scientific ambition, patient needs, product quality, regulatory expectations, manufacturability, supply reliability, timelines, and cost.

  • Demonstrated ability to collaborate effectively across global development teams, functions, cultures, and organizational…

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