Position purpose :
Lead late-phase drug substance (DS) process development and process transfer activities, provide scientific support within Drug Substance Lead group, Schaftenau / Kundl area.
Major accountabilities / area of responsibilities :
Provide scientific leadership for various late-phase drug substance development activities, e.g. process characterization;
manufacturing process transfers.
Collaborate closely with key stakeholders, interfaces within the organization and maintain efficient communication towards them.
Write / lead / review defined development related documentation, e.g. characterization studies, transfer protocols, reports; control strategy documents.
Lead / contribute to various DS development related or project management related meetings, e.g., CMC meetings, troubleshooting meetings.
Contribute to responses for health authorities, support audits and inspections.
Ensure that the right and consistent development resources are applied, contribute / support achieving top performance.
Contribute to continuous improvement of scientific knowledge and approaches.
Ensure, strengthen the application of harmonized standards, relevant SOPs.
Advanced degree in life sciences.
Minimum 5 years of experience from biotechnology / pharmaceutical environment.
Excellence in English (oral and written).
Ph.D. in scientific discipline (e.g. Bio-or chemical engineering, pharmacy, chemistry), preferably with focus on biopharmaceutical processes.
Excellent communication skills in English (oral & written); German knowledge is a plus.
Experiences and solid understanding of biologics DS development and / or large-scale manufacturing processes.
Experiences with Pre-Approval Inspections, reviewing submission documents to health authorities, and knowing GMP is a key advantage.
Excellent organizational skills, team player, flexible and dedicated personality.
Demonstrated skills working in cross-functional / international environment.
Ability to coordinate a number of tasks simultaneously, prioritize and deliver against tight timelines.
Ability to design / evaluate / summarize / report upstream and downstream development studies, DoEs.
Ability to lead / facilitate meetings composed of cross-functional experts.
Excellent problem solving mind-set, attitude to resolve challenges, interdisciplinary thinking.
Ability of properly balancing between efforts, risks and benefits.
Please apply online (Job ID 249235BR)
Contact : Marcel Otto, Talent Acquisition & Staffing Business Partner
We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group.
The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least € 54.960 per year).