PHAD PDU Oral Drug Product Project Leader
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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.
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 partiesAssess, 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 substance and excipient properties, 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 boundaries in a complex matrix environment. Brings an open and inclusive mindset, cultural awareness, adaptability, and comfort with ambiguity; builds trusted relationships, listens to and integrates diverse perspectives, influences without formal authority, constructively resolves differences, aligns stakeholders around shared priorities, and communicates transparently to enable timely decisions and shared accountability.Demonstrates high ethical standards, sound judgment, quality ownership, transparency, and consistent leadership behaviours, particularly when facing pressure or conflicting objectives.Strong knowledge of relevant GLP, GMP regulations and policies.A collaborative mindset combined with an interest in improving how work is structured and executed, including the ability to bring clarity, consistency, and efficiency to development activities. Strong interpersonal skills, including coaching other and developing people Benefits & Rewards At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. Expected Annual Base Salary Range for role: CHF 93,800 to CHF 174,200 The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.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 diversity.inclusion_ch@novartis.com 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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