Principal Scientist - Drug Product Lead (m/f/d)
- Kufstein, Austria
Principal Scientist - Drug Product Lead (m/f/d), Global Drug Development, Schaftenau, Austria
10-15 years experience with marketed Biosimilars and Biologics! More than 40 years of experience in Biotech production and a growing product portfolio exploiting new key technologies.
As a Principal Scientist - Drug Product Lead (m/f/d) you will be working in an international team with the goal to bring our Medicines to the global market in order to make medical treatment accessible for patient around the world. Apply now and become a part of our dynamic team!
• Drug Product Lead is strategic lead of overall Drug product development of Biologics and is accountable for agreed upon deliverables to the CMC team
• Lead author for technical source documents, e.g. Development Reports, Risk Assessments, Manufacturing Instructions, Campaign Experience Reports, Control Strategy, Pre-Validation Protocol and Report
• Author or review regulatory CMC documents and communicates with health authorities, if required
• Design, plan, perform, interpret and document scientific experiments for the pharmaceutical development of stable liquid and lyophilisate formulations, robust manufacturing processes of syringes, cartridges, vials and other presentations, characterization of formulation and process; upscale and transfer of processes and supports process validation and registration of the product
• Lead the global drug product sub-team with cross-functional member to ensure appropriate product development concerning all aspects of DP and in alignment with interface functions (e.g. Regulatory, Device, Production and QA)
• Set priorities for the team; support the growth of DP team members and motivate them as appropriate by an encouraging and servant leadership
• Proactively communicate overall project strategy and resource demand. Adapt project strategy and prioritize project activities, according to agreed upon timelines
• Ensure the pre-clinical trial supplies if required from the project
What you'll bring to the role:
• Technical expert studies (Pharmaceutical Technology) with PhD and 2 years relevant industrial experience or Master of Science with 6 years of relevant experience or Bachelor of Science or equivalent technical education with 12 years experience
• Thorough understanding of Drug product development activities and processes of Biologicals; excellent theoretical and scientific knowledge in the relevant area of expertise including proficiency with technical equipment
• Scientific project management and leadership skills as well as presentation skills
• Proficient scientific/technical writing skills
• Fluent in English (oral and written)
• Good understanding of pharmaceutical development of Biologics of and basic project management skills
• Team player
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 € 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.
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
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