Oral Drug Product Project Lead, PDU – Basel (Onsite)

Novartis AG

Basel

On-site

CHF 94,000 - 174,000

Full time

5 days ago
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Benefits offered by this job

Insurance plans
Retirement plans
Wellbeing resources
Global recognition programs
Flexible/hybrid working
14 weeks parental leave

Job summary

Novartis AG in Basel, Switzerland, is seeking a Drug Product Project Leader (DPPL) to lead late-phase oral drug product development programs. You will direct DP technical development, ensure scientific excellence and quality, and align with project objectives across internal and external partners.

The role requires an advanced degree, 5+ years in pharmaceutical formulation development, and strong knowledge of QbD, GMP/GLP.

Qualifications

  • Advanced degree in Pharmaceutical Technology, Powder Process Engineering or related field; PhD or equivalent experience valued.
  • Strong knowledge of GLP, GMP regulations and policies and biopharmaceutics.
  • Excellent leadership, project management and presentation skills, with ability to convey complex topics clearly.
  • Ability to balance scientific ambition, patient needs, product quality, regulatory expectations, manufacturability, supply reliability, timelines and cost.

Responsibilities

  • Represent DP project teams with quality awareness, scientific expertise and technical leadership.
  • Develop robust DP project strategies including contingency planning and risk assessments.
  • Lead budgeting and resource planning for DP activities across projects.
  • Ensure adherence to governance boards and DP strategies within project teams.
  • Oversee DP development documentation for CMC submissions and regulatory responses.
  • Support Make vs Buy decisions and manage outsourced activities with external partners.

Skills

Leadership
Project management
Communication
Quality by Design
Cross-functional collaboration

Education

Advanced degree in Pharmaceutical Technology / Powder Process Engineering
PhD or equivalent experience valued

Job description

Novartis AG in Basel, Switzerland, is seeking a Drug Product Project Leader (DPPL) to lead late-phase oral drug product development programs. You will direct DP technical development, ensure scientific excellence and quality, and align with project objectives across internal and external partners.

The role requires an advanced degree, 5+ years in pharmaceutical formulation development, and strong knowledge of QbD, GMP/GLP.

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