Analytical Project Leader (f/m/d), Global Drug Development, Schaftenau (Austria), Mengeš (Slovenia) or Oberhaching (Germany)
>200! This the current number of programs in clinical development at Novartis.
Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide. We are looking for you as an experienced Analytical project leader to join our team in Schaftenau or in Mengeš or in Oberhaching to support development of these projects. Please mention in your Cover Letter for which location you are applying.
Your key responsibilities:
Your responsibilities include, but are not limited to:
• You will lead and coordinate the analytical sub-team and represent analytic in the global CMC project team of assigned projects.
• You are accountable for managing all analytic related activities of Drug Product and Drug Substance development incl. release and stability-testing, characterization of the API, method-development, -transfer and -validation, specification setting, know-how transfer etc.
• You will need to communicate effectively across organizational interfaces i.e. project-/program-management; line functions etc.
• You will proactively identify scientific, technological and GMP issues, propose creative solutions and communicate key issues to the appropriate management level
• You are responsible for high quality analytical registration documents for HA submissions and you will Interact with authorities, act as technical expert in audits, inspections etc.
• You are responsible for analytical budget and resource planning
What you'll bring to the role:
• University degree in biotechnology, biochemical engineering, biology, chemistry, biochemistry or similar with 5 years relevant experience of biologics CMC development
• Previous experience in analytical areas in biologic drug development in an industrial setting
• Excellent understanding of regulatory expectations and requirements
• Proficiency in English
• German is beneficial
• Proven leader with experience in managing teams
• Proven track record of creativity, problem solving and productivity
• Proficient scientific/technical writing skills
• Demonstrated excellent communication, presentation and management skills
• Worked in interdisciplinary teams with excellent theoretical and scientific knowledge of product development
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!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is EUR 51,180.50/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. We are open for part-time and job sharing models and support flexible working and home-office where possible.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.
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