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

Summary

Location: Basel, Switzerland

Role Purpose:
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 working on oral dosage forms, you will lead and manage formulation and manufacturing activities linked to pharmaceutical development for small molecules (New Chemical Entities; NCE) for assigned projects. For this position, specific emphasis lies on bringing in-depth experience in applied data science, mechanistic modelling and simulation of pharmaceutical unit operations.
You will lead drug product teams during all stages of development but with a focus on initial clinical phases. You will be working on oral Small Molecules and in particular on enabling formulation approaches. You will use your strong communication and influencing skills to effectively lead the drug product subteam. Your expertise will facilitate the creation of innovative and stable drug products suitable for human trials and commercial supplies.

About the Role

Your responsibilities will include but are not limited to:

• You lead and manage all Drug Product (DP) related technical development activities for assigned projects and you represent DP project teams in Technical Research and Development (TRD) sub-teams based on your strong scientific and pharmaceutical development expertise.
• You lead, manage and support the DP team in line with Novartis values and behaviors. You build strong team spirit and promote knowledge exchange within and between teams. You motivate and coach team members for high performance. Provide input on performance of team and team members.
• You formulate a sound DP project strategy incl. contingency planning and risk assessments as appropriate, involving functional experts and you ensure alignment with Pharmaceutical Development department and othefrmulatr departments and functions inside and outside of TRD and 3rd parties as appropriate.
• You assess, consolidate and negotiate resource needs and timelines for assigned projects 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 scientific and project 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.
• You lead, manage and support the DP team in line with Novartis values and behaviors. You build strong team spirit and promote knowledge exchange within and between teams. You motivate and coach team members for high performance.

What you'll bring to the role:

• Advanced degree in relevant scientific field (e.g. Pharmaceutical Technology, Chemistry)
• Minimum 2-4 years of successful industry experience in the development of pharmaceutical formulations in a matrix organization.
• Successfully demonstrated expertise in a specific scientific/technical area of Biopharmaceutical sciences, understanding of physical-chemical properties of molecule and impact on in-vivo performance. Knowledge on oral biopharmaceutics, biopharmaceutical modeling and defining bridging strategies is desirable.
• Strong project management skills, ability to solve complex problems in a matrix system with good communication, organizational, planning and negotiation skills (German language skills desired).
• Interdisciplinary thinking and interest in collaboration with other functions.
• Broad and profound understanding of development activities and processes in pharmaceutical sciences.
• Good knowledge of laboratory and/or technical tools as well as knowledge of relevant GLP, GMP regulations and policies.
• Strong presentation skills and scientific/technical writing skills.

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Development

Business Unit
Innovative Medicines

Location
Switzerland

Site
Basel (City)

Company / Legal Entity
C028 (FCRS = CH028) Novartis Pharma AG

Functional Area
Research & Development

Job Type
Full time

Employment Type
Regular

Shift Work
No