Analytical Project Lead – Associate Director

Job title:

Analytical Project Lead – Associate Director

Company

Novartis

Job description

Job Description Summary Analytical Project Lead -Associate Director Science & Technology
LOCATION: Schaftenau, Austria
TYPE: Hybrid Working #LI-HybridWe are a global team of highly skilled analytical project managers with presence in all biologics technical research and development sites of Novartis in Europe. We are looking for you as an experienced, curious, inspiring Associate Director / Analytical Project Leader (APL) to join our team to support development of our biologic product pipeline. The APL is the strategic lead of overall analytical development (AD) and is accountable for agreed upon deliverables to the Chemistry Manufacturing & Controls (CMC) team and the scientific content of development program.Job DescriptionKey Responsibilities:Your responsibilities include, but are not limited to:Representing AD on the CMC core team & lead the global analytical sub-team with cross functional membersLeading and coordinating timely delivery of high quality source documents for submission, review of regulatory documents (e.g. CMC modules, briefing books) and interactions with Health Authorities in audits and scientific advice meetingsSupporting the growth of the sub-team members and motivating them as appropriate by encouraging and servant leadershipLeading and managing all analytic related activities of drug product and drug substance development including release and stability-testing, characterization of the active pharmaceutical ingredient (API), method-development, -transfer and -validation, specification setting, know-how transfer etc., critically evaluating results and drawing relevant conclusionsCommunicating effectively across organizational interfaces i.e. project-management, line functions, senior management, etc.Proactively identifying scientific, technological and Good Manufacturing Practice (GMP) issues, proposing creative solutions and communicating key issues to the appropriate management levelResponsibility for analytical budget and resource planningEssential Requirements:PhD and minimum of 8 years relevant experience of Biologics CMC development or University life-science degree with appropriate industry experiencePrevious experience in analytical areas in biologic drug development in an industrial settingExcellent understanding of regulatory expectations and requirements with significant experience with IND/ BLA submissionProficiency in EnglishProven leader with minimum of 5 years experience in managing teams/ projectsProven track record of creativity, problem solving and productivityProficient scientific/technical writing skillsDesirable Requirements:Demonstrated excellent communication, presentation and management skillsWorked in interdisciplinary teams with excellent theoretical and scientific knowledge of product developmentWhy 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-cultureYou’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-rewardsIn 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 €89,600 per year (on a full-time basis). The actual salary will be significantly 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 and remote working where possible.Commitment to Diversity & Inclusion:Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.Adjustments for Applicants with Disabilities:If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to 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, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.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:Skills Desired Budget Management, Coaching Skills, Data Science, Experiments Design, Laboratory, Problem Solving Skills, Process Simulation, R&D, Waterfall Project Management

Expected salary

Location

Österreich

Job date

Sun, 24 Nov 2024 03:47:17 GMT

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