Senior Expert – Process Analytical Sciences (m/f/d)

Job title: Senior Expert – Process Analytical Sciences (m/f/d)

Company: Novartis


Job description: Job Description Summary #LI-HybridWe are seeking a highly skilled and motivated Senior Expert to develop and implement analytical strategies to support late-phase product development and regulatory submissions for accelerated Biologics portfolio projects.In the role of Senior Expert – Process Analytical Sciences, you will play a key role in driving Extractable and Leachable activities within late-phase development of New Biological Entity and Biosimilar projects. Your primary responsibility is to guide and manage activities within cross-functional project teams.Job DescriptionKey Responsibilities:
Your responsibilities include but are not limited to:Lead and represent in cross-functional project teams, acting as a single point of contact (SPOC) for all extractable and leachable related topics.Plan, manage, and control project resources, schedules, budgets and outsourcing activities.Review and Approval of laboratory data, internal and external documents.Writing and providing scientific justification for risk assessments, study protocols, study reports in the field of extractables & leachables.Ensure compliance with internal process requirements and current regulations.Support mock PAI’s (Pre-Approval Inspections) and Audits as Subject Matter Expert (SME).Prepare Biologics License Application (BLA) Submission relevant reports, assist teams in regulatory dossiers preparation and in responding to health authority questions.Proactively lead and drive initiatives independently, taking ownership from concept to execution while ensuring successful outcomes.Essential Requirements:Master or PhD (preferred) in natural science, engineering, pharmaceutical field or equivalent.Minimum 3-5 years of experience in the pharmaceutical industry, preferably in Extractables & Leachables and/or late phase development.Excellent and extensive analytical understanding, e.g. HS-GC/MS, GC/MS, HPLC/MS.Ability to work and lead a cross-functional team in a matrix environment.Proven knowledge and track record in project and program planning and execution.Understanding and awareness of regulatory standards and guidelines for Extractables and Leachable’s, e.g USP
1663
,
1664
,
1665
,
665
, ISO-10993-17, ISO-10993-18.Collaborative spirit, self-driven attitude, high level of learning agility, good listening skills, strategic thinker.Fluent in German (oral and writing) and English (oral and writing).You’ll receive:You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.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 € 65,605.54 a 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.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 DisabilitiesIf because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com 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.Skills Desired Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model

Expected salary: €65605.54 per year

Location: Österreich

Job date: Sat, 05 Jul 2025 22:08:52 GMT

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