Drug Product Project Leader (Oral Drug Products)

About the role

Novartis is looking for a Drug Product Project Leader (DPPL) in Basel, Switzerland, an onsite role leading late-phase oral drug product development programs. You will lead Drug Product technical development activities, build project strategies and risk assessments, and coach and develop project teams.

Key responsibilities

• Represent DP project teams in TRD sub-teams and provide quality awareness, scientific expertise and technical leadership.
• Develop DP project strategies, including contingency planning and risk assessments, and align with internal functions, partners and third parties.
• Negotiate resources, timelines and costs, and lead the budgeting process for DP activities.
• Ensure adherence to project review processes and governance boards, and implement approved DP strategies within the team.
• Manage cross-functional interactions, monitor project plans and deliverables, and oversee high-quality development documentation for CMC submissions.
• Integrate scientific insight into drug substance and excipient properties, formulation design and process parameters, and apply quality-by-design, modelling and digital tools.
• Lead, coach and support DP teams, and act as author, reviewer or approver of development documents in line with SOPs.
• Drive make-versus-buy strategies and support outsourced activities, including input into contracts, quality agreements and third-party supply projects.

Required profile

• Advanced degree in Pharmaceutical Technology, Powder Process Engineering or a related scientific field; PhD or equivalent experience valued.
• Minimum 5+ years of industry experience in pharmaceutical formulation development, preferably early and late phase oral dosage forms.
• Strong leadership, scientific, project management and presentation skills, and the ability to balance quality, regulatory expectations, manufacturability, cost and timelines.
• Proven ability to collaborate across global development teams in a complex matrix environment.

Required skills

• Solid understanding of Quality by Design (QbD) and regulatory guidelines (ICH Q8, Q9, Q10).
• Broad understanding of development activities and processes in pharmaceutical sciences.
• Knowledge of relevant GLP and GMP regulations and policies.

What we offer

• Base salary range of CHF 93,800 to CHF 174,200, with a possible performance-based bonus.
• Insurance plans, retirement plans, wellbeing resources and global recognition programs.
• Flexible and hybrid working options where possible, and at least 14 weeks of paid parental leave.