Résumé
About the Role
Purpose:
The Technical Project Leader will, jointly with the CMC team, lead and manage all technical development activities for assigned small molecule projects within Technical Research & Development (TRD); represent TRD as core member in global project teams to define the global CMC strategy for the development, submission, approval and life cycle management of a product(s); improve the support to local programs and partners; lead CMC teams with strong strategic focus, quality & environmental awareness, scientific and technical expertise; act as the TRD representative in complex projects involving external partners and/or highly innovative projects/processes.
Major Responsibilities but not limited to :
- Lead the establishment of a scientifically & regulatory sound and business driven CMC project strategy including risk assessments and contingency planning, in line with overall global development project strategy and together with assigned CMC team.
- Ensure alignment with departments and functions inside and outside of TRD as well as 3rd parties as appropriate. Drive endorsement of CMC project strategy by respective Novartis boards.
- Proactively communicate overall project strategy, key risks, issues and any other critical topics in a timely manner to the appropriate management level, customer and team members. Ensure that issues are resolved in a timely fashion.
- Understand and proactively manage the cross-functional aspects of assigned project(s) among departments within and outside TRD (e.g. Regulatory, Safety, Clinical, Production, Research). Lead the CMC subteam(s) in a complex international matrix organization in line with the culture, values and behaviors of Novartis.
- Build strong team spirit and promote knowledge exchange within and between teams. Align project objectives and priorities with team(s) members. Support in- and out licensing of projects by shaping global technical development strategy for post-due diligence projects under negotiation.
Minimum Requirements:
- Education: Ph.D. or equivalent in chemistry, biochemistry, biotechnology, biology, pharmacy or related science.
- Minimum 8 years of experience within the pharmaceutical industry, preferably in the field of technical development; minimum of 5 years of experience in a leadership position.
- Demonstrated minimum of 3-5 years project management excellence in technical development department (e.g. several years of experience as CMC project leader or senior line function position) or equivalent experience.
- Proven track record in successfully leading interdisciplinary teams, e.g. scientists working on technical or methodological projects (incl. budget control), in Technical R&D or equivalent experience. Proven ability to work proactively and think strategically, including assessment of business impact of technical decisions.
- Excellent verbal and written communication skills with success in building trustful relationships and influencing others in cross-functional areas including customer management.
- Excellent knowledge of the Pharma Drug Discovery & Development process.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
