Drug Substance Project Lead (Associate Director) (m/f/d)

<p><b>Band</b></p>Level 5<p><br/> </p><p><b>Job Description Summary</b></p>LOCATION: Schaftenau, Austria<br/>ROLE TYPE: Hybrid, #LI-Hybrid<br/><br/>We are a global team of highly skilled Drug Substance project managers with presence in all biologics technical research and development sites of Novartis in Europe, and we are looking for you as an experienced, curious, inspiring Drug Substance Project Leader to join our team to support development of our biologic product pipeline.<p><br/> </p><p><b>Job Description</b></p><p><b>K</b><b>ey Responsibilities</b><span><b>:</b></span></p><ul><li><p>You will lead and coordinate the drug substance sub-team and represent the drug substance process development discipline in the global CMC project team of assigned projects.</p></li><li><p><span>You are accountable for managing all activities related to drug substance development including upstream and downstream process, e.g. process development, tech transfers to production sites, process validation, DS supply, documentation etc.</span></p></li><li><p><span>You will need to communicate effectively across organizational interfaces i.e. project-management, line functions, senior management, quality assurance, drug product and analytics etc.</span></p></li><li><p><span>You will proactively identify scientific, technological and GMP issues, propose creative solutions and communicate key issues to the appropriate management level</span></p></li><li><p><span>You will contribute to high quality drug substance registration documents for HA submissions and support interactions with authorities (e.g. technical expert in audits, inspections etc.)</span></p></li><li><p><span>You are responsible for drug substance budget and resource planning</span></p></li></ul><p></p><p><b><span>What you will bring to the role </span></b></p><ul><li><p>MSc or PhD in Natural Science</p></li><li><p>Minimum of 5 years relevant experience of Biologics CMC development and/or production</p></li><li><p>Proficiency in English</p></li><li><p>Experience in working and leading in a matrix structure</p></li></ul><p><br/><b><span>Desirable Requirements:</span></b></p><ul><li><p>Demonstrated excellent communication, presentation and management skills</p></li><li><p>Worked in interdisciplinary teams with excellent theoretical and scientific knowledge of product development</p></li></ul><p></p><p><b>You’ll receive:  </b></p><p>You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. <a href="https://www.novartis.com/careers/benefits-rewards" rel="noopener noreferrer" target="_blank"><span>https://www.novartis.com/careers/benefits-rewards</span></a></p><p>In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities 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 € 78,383.90 /year (on a full-time basis).</p><p>We also offer a potential market oriented excess payment in line with your experience and qualifications.</p><p></p><p><b>Commitment to Diversity &amp; Inclusion: </b></p><p>Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.</p><p></p><p><b>Adjustments for Applicants with Disabilities: </b></p><p>If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to <a href="mailto:disabilities.austria@novartis.com" rel="noopener noreferrer" target="_blank"><span>disabilities.austria@novartis.com</span></a> and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, <span>Behindertenvertrauensperson</span> (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.</p><p></p><p></p><p><br/> </p><p><b>Skills Desired</b></p>Budget Management, Coaching Skills, Data Science, Experiments Design, Laboratory, Problem Solving Skills, Process Simulation, R&amp;D, Waterfall Model