AS&T Expert

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH; Osterreich; Vor Ort; PEN 258.000 - 406.000; Vollzeit

Zusammenfassung

Novartis Pharmaceutical Manufacturing GmbH in Kundl, Austria, seeks an Analytical Science and Technology Expert to coordinate analytical activities across products, lead method transfers and stability studies, and provide scientific expertise in GMP-compliant settings.

The role involves lifecycle management of analytical methods, deviation handling, audits, and collaboration with MTF, analytical development, production, QA and regulatory teams.

Qualifikationen

• University degree (or FH) in natural science/technical field or equivalent education.
• Approx. 3 to 5 years in pharmaceutical industry and/or analytical GMP laboratory experience.
• MS Office and standard IT applications.
• Fluent in English and German.

Aufgaben

• Management and oversight of all analytical activities within responsible projects.
• Coordination and management of analytical method transfers and stability studies.
• Presentation and discussion of analytical data in local and international project teams.
• Life-cycle management of analytical methods, including validation, compliance and improvements.
• Handling deviations, investigations, OOS/OOE/OOT cases, changes and complaints.
• Point of contact for analytical questions from health authorities and audits/inspections.
• Cross-functional interface with Manufacturing Science & Technology, analytical development, production, QA and regulatory.
• Implementation of GMP requirements.
• Compilation and review of documents (protocols/reports, PQRs, process verification reports, registrations).
• Budgeting and cost control of external analytical activities.
• Management of reference substances and control samples.

Kenntnisse

English (Fluent)

German (Fluent)

MS Office

Ausbildung

University degree or FH in natural science/technical background

Tools

MS Office

Jobbeschreibung

Salary Range: €66,918.00 - €105,200.00 Band Level 4 Job Description Summary #LiHybrid Location: Kundl - Austria.

This role is based in Kundl, Austria. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

The Analytical Science and Technology (AS&T) Expert is responsible for coordinating and managing analytical activities across products, including both customer-related projects and innovative Novartis initiatives, and for providing scientific analytical expertise and support.

Job Description Major Accountabilities

• Management and oversight of all analytical activities related within responsible projects.
• Coordination and management of analytical method transfers and stability studies.
• Presentation and discussion of analytical data in local and international project teams.
• Life-cycle management of analytical methods, including control of method performance, analytical method validation, pharmacopoeia and health authority compliance and definition of method improvements.
• Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints.
• Person of contact for analytical questions from health authorities and analytical subject matter expert during audits and inspections.
• Cross-functional interface with Manufacturing Science & Technology team, analytical development, production, quality assurance and regulatory department.
• Implementation of GMP requirements.
• Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents).
• Budgeting and cost control of external analytical activities.
• Management of reference substances and control samples.

Essential Requirements

• University degree or FH with natural science/technical background (e.g. chemistry, pharmacy, biology) or equivalent education.
• Approx. 3 to 5 years in pharmaceutical industry and/or analytical laboratory in GMP environment.
• MS Office- and other standard IT applications.
• Fluent in English and German.

We offer a 2-year temporary contract for this role.

Rewards

Rewards You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards 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 € 66,918.00 /year (on a full time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications. The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process. Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Skills Desired

Collaboration, Communication, Data Integrity, Decision Making, Digital Fluency, Good Manufacturing Practices (GMP), Health Safety Regulations, Intelligent Risk Taking, Laboratory Testing, Leadership, Managing Ambiguity, Operational Excellence, Organizational Savvy, Problem Solving, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Inspections, Quality Management Systems (QMS), Regulatory Compliance, Statistical Process Control (SPC) Improving the lives of people living with disease takes more than innovative science.

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