Drug Product Project Leader – Oral Dosage Forms (80-100%*)

Oct 06, 2021

Job Description

105,000! The number of outstanding individuals who work at Novartis, all with needs and aspirations, aligned to a single inspirational purpose: to Reimagine Medicine for millions of patients around the world!

Novartis holds a rich development portfolio of small molecules ready to develop into innovative patient centric oral dosage forms. As a Drug Product Project Leader, you will lead and manage all project activities linked to pharmaceutical development for oral dosage forms for small molecules (NCE) with focus on early phase development activities. The purpose of that role is to define and develop formulations and manufacturing process for early phase clinical trials and establish a strategy towards late phase formulation development our future Drug Products.

Your responsibilities will include but are not limited to:

• You will lead all Drug Product (DP) related technical development activities for assigned projects and you represent DP project teams in Technical Research and Development (TRD) sub-team based on your strong scientific and pharmaceutical development expertise.
• You lead, manage and support the DP team in line with Novartis values and behaviors. Champion the “Blue Culture”. You build team spirit and promote knowledge exchange within and between teams. You empower and mentor team members for performance. Provide input on performance of team and team members.
• You formulate a DP project strategy incl. contingency planning and risk assessments as appropriate, involving functional experts and you ensure alignment with Pharmaceutical Development department and other departments and functions inside and outside of TRD and 3rd parties as appropriate.
• You assess, consolidate and negotiate resource needs and timelines within the DP project team and ensure resources are accurately reflected in the planning systems.
• You ensure adherence to the scientific and project review process and through relevant management governance boards. You ensure creation of high quality and scientific sound DP development documents enabling a strong CMC submission package and act as author, reviewer or approver role for development documents in accordance to the Operational procedures and guidelines.
• You contribute to the generation of filing dossiers, answer DP related questions in inspections and support Health Authority requests.

*Some restrictions on flexible working options may apply and will be discussed during interview if applicable.

Minimum Requirements

What you’ll bring to the role:
• Advanced degree in relevant scientific field (e.g. Pharmaceutical Technology, Chemistry)
• Minimum 3-5 years of proven experience in the development of pharmaceutical formulations. Focus: Formulation development (small molecules NCE) and scale up of manufacturing processes into oral drug products for commercialization
• Interdisciplinary thinking and interest in collaboration with other functions
• Broad and profound understanding of development activities and processes in pharmaceutical sciences. (Early phase and Late phase development)
• Good knowledge of laboratory and/or technical tools (e.g. QbD, PAT) as well as knowledge of relevant GLP, GMP regulations and policies
• Strong presentation skills and scientific/technical writing skills
• Strong project management skills, ability to solve complex problems in a matrix system with good communication and negotiation skills

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Global Drug Development
Research & Development
Full Time
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Drug Product Project Leader – Oral Dosage Forms (80-100%*)

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