Process Expert (m/f/d)

Novartis Holding GmbH

Summary

#LI-Hybrid

Location: Kundl, Austria

At Novartis, we are reimagining medicine to improve and extend people's lives. As a Process Expert at the Nucleic Acid Facilities (NAF), you will play a critical role in establishing and operating next-generation manufacturing processes for plasmid DNA, mRNA, and lipid nanoparticle (LNP) technologies. You will combine technical expertise, GMP compliance, and cross-functional collaboration to ensure reliable and efficient manufacturing of innovative therapies for patients worldwide.

As part of the Nucleic Acid Manufacturing organization in Kundl, you will serve as a process expert supporting manufacturing operations across the product lifecycle, from technology transfer and process validation through routine commercial production and continuous improvement.

You will work in close partnership with Manufacturing, MS&T, QA, QC, Engineering, Supply Chain, and external partners to drive process robustness, operational excellence, and regulatory compliance.

Key Responsibilities

  • Serve as the process owner and technical expert for nucleic acid manufacturing processes.
  • Provide real-time technical support to GMP manufacturing operations and shopfloor teams.
  • Analyze process performance data to identify trends, risks, and improvement opportunities.
  • Lead or support investigations, root cause analyses, CAPA implementation, and change controls.
  • Author and maintain GMP documentation including SOPs, manufacturing instructions, risk assessments, and technical reports.
  • Support process validation, process qualification, and Continued Process Verification activities.
  • Drive operational excellence initiatives focused on safety, quality, compliance, delivery, and cost.
  • Collaborate with cross-functional teams to implement process improvements and technology transfers.
  • Support health authority inspections and internal audits.
  • Train and coach manufacturing personnel on process-related topics.

Essential Requirements

  • Degree in Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Life Sciences, or a related field.
  • Experience within a GMP-regulated pharmaceutical, biotechnology, biologics, vaccine, or nucleic acid manufacturing environment.
  • Strong understanding of pharmaceutical manufacturing processes and process lifecycle management.
  • Experience with deviation management, CAPAs, risk assessments, and change control systems.
  • Solid analytical and problem-solving skills with the ability to interpret manufacturing data and trends.
  • Excellent communication and stakeholder management capabilities.
  • Fluency in German and English.

Desirable Requirements

  • Experience with plasmid DNA, mRNA, LNP, or biopharmaceutical manufacturing processes.
  • Knowledge of process validation, technology transfer, and process characterization.
  • Experience with GMP systems such as SAP, MES, eQMS, and electronic documentation systems.
  • Knowledge of EU GMP requirements and data integrity principles.

Benefits & Rewards

Expected annual base salary range for role: EUR 60,978.00 to EUR 89,300.00. The base salary offered is determined based on relevant skills, competencies and experience. In addition to the base salary, you may be eligible for a performance-based bonus.

Novartis also offers benefits such as insurance plans, retirement plans, wellbeing resources, global recognition programs, flexible and hybrid working options where possible, and minimum 14 weeks paid parental leave.

Read more about the global total rewards offering: Novartis Life Handbook

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Process Expert (m/f/d)

Novartis Holding GmbH

Summary

#LI-Hybrid

Location: Kundl, Austria

At Novartis, we are reimagining medicine to improve and extend people's lives. As a Process Expert at the Nucleic Acid Facilities (NAF), you will play a critical role in establishing and operating next-generation manufacturing processes for plasmid DNA, mRNA, and lipid nanoparticle (LNP) technologies. You will combine technical expertise, GMP compliance, and cross-functional collaboration to ensure reliable and efficient manufacturing of innovative therapies for patients worldwide.

As part of the Nucleic Acid Manufacturing organization in Kundl, you will serve as a process expert supporting manufacturing operations across the product lifecycle, from technology transfer and process validation through routine commercial production and continuous improvement.

You will work in close partnership with Manufacturing, MS&T, QA, QC, Engineering, Supply Chain, and external partners to drive process robustness, operational excellence, and regulatory compliance.

Key Responsibilities

  • Serve as the process owner and technical expert for nucleic acid manufacturing processes.
  • Provide real-time technical support to GMP manufacturing operations and shopfloor teams.
  • Analyze process performance data to identify trends, risks, and improvement opportunities.
  • Lead or support investigations, root cause analyses, CAPA implementation, and change controls.
  • Author and maintain GMP documentation including SOPs, manufacturing instructions, risk assessments, and technical reports.
  • Support process validation, process qualification, and Continued Process Verification activities.
  • Drive operational excellence initiatives focused on safety, quality, compliance, delivery, and cost.
  • Collaborate with cross-functional teams to implement process improvements and technology transfers.
  • Support health authority inspections and internal audits.
  • Train and coach manufacturing personnel on process-related topics.

Essential Requirements

  • Degree in Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Life Sciences, or a related field.
  • Experience within a GMP-regulated pharmaceutical, biotechnology, biologics, vaccine, or nucleic acid manufacturing environment.
  • Strong understanding of pharmaceutical manufacturing processes and process lifecycle management.
  • Experience with deviation management, CAPAs, risk assessments, and change control systems.
  • Solid analytical and problem-solving skills with the ability to interpret manufacturing data and trends.
  • Excellent communication and stakeholder management capabilities.
  • Fluency in German and English.

Desirable Requirements

  • Experience with plasmid DNA, mRNA, LNP, or biopharmaceutical manufacturing processes.
  • Knowledge of process validation, technology transfer, and process characterization.
  • Experience with GMP systems such as SAP, MES, eQMS, and electronic documentation systems.
  • Knowledge of EU GMP requirements and data integrity principles.

Benefits & Rewards

Expected annual base salary range for role: EUR 60,978.00 to EUR 89,300.00. The base salary offered is determined based on relevant skills, competencies and experience. In addition to the base salary, you may be eligible for a performance-based bonus.

Novartis also offers benefits such as insurance plans, retirement plans, wellbeing resources, global recognition programs, flexible and hybrid working options where possible, and minimum 14 weeks paid parental leave.

Read more about the global total rewards offering: Novartis Life Handbook

Bewerben

Hauptstandort

Random Phone Number
randomemail@example.com

Ansprechpartner

Hauptstandort

Random Phone Number
randomemail@example.com

Ansprechpartner