KI-Beschreibung

As the Associate Director of Analytical Operations, you will lead a dedicated team in Austria, guiding them through technical and project management challenges while ensuring compliance and fostering professional growth. This role involves strategic oversight of Late-Phase projects, collaboration with stakeholders, and driving operational excellence.

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  Strong experience in biotechnological Chemistry Manufacturing Control (CMC) development
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  Minimum of 10 years of experience in the pharmaceutical industry
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  Minimum of 5 years in a leadership position

Deine Vorteile

KI-Beschreibung

In this role, you will be at the forefront of generating and analyzing critical data for medical devices, ensuring compliance with regulations, and leading innovative lab projects. Your day-to-day responsibilities will involve testing, documentation, and collaboration with project teams to enhance product quality.

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  Apprenticeship or secondary school, or bachelor's or master's degree in Technical/
  Engineering/
  Life-Sciences
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  Knowledge in Environment, Experiments Design, Health And Safety (EHS), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, SOP (Standard Operating Procedure), Technical Writing, Waterfall Model

Deine Vorteile

KI-Beschreibung

In this role, you will drive the global regulatory strategy for CMC, ensuring compliance and quality in submissions. Your day-to-day responsibilities will involve collaborating with cross-functional teams, negotiating with health authorities, and providing strategic guidance to enhance project outcomes.

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  Science degree (Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent
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  Minimum 8 years regulatory experience preferred or pharmaceutical industry experience
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  Substantial knowledge/
  experience in regulatory submission and approval processes

Deine Vorteile

KI-Beschreibung

You will develop and implement global regulatory strategies for CMC, manage submission activities, and ensure compliance while collaborating with cross-functional teams and engaging with health authorities.

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  Minimum 8 years regulatory experience preferred
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  Substantial knowledge in regulatory submission
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  Proven ability to evaluate scientific data

Deine Vorteile

KI-Beschreibung

As a Senior Manager in RA CMC, you will shape global regulatory strategies for drug development, ensuring compliance while driving innovation. This role involves leading submission activities, managing risks, and collaborating with cross-functional teams to enhance patient outcomes.

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  Minimum 5 years of regulatory CMC experience or pharmaceutical industry experience
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  Science degree or equivalent
• •
  Knowledge in regulatory submission and approval processes

Deine Vorteile

KI-Beschreibung

As a Senior Manager in RA CMC, you will shape global regulatory strategies for drug development, ensuring compliance while driving innovation. Your role involves leading submission activities, managing documentation, and engaging with Health Authorities to navigate the regulatory landscape.

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  Minimum 5 years of regulatory CMC experience or pharmaceutical industry experience
• •
  Knowledge in regulatory submission and approval processes
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  Science degree or equivalent; advanced degree desired

Deine Vorteile

KI-Beschreibung

In this role, you will actively support the development of innovative drug candidates by conducting experiments and analyzing data. You will also document your findings and collaborate with the team to enhance processes, gaining valuable insights into drug substance development.

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  Enrollment in a Master’s program in life science
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  Interest or knowledge in data science, statistical data analysis, process modeling, simulation, automation, and basic programming
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  Advanced communication skills in English

KI-Beschreibung

In this role, you will actively support the development of innovative drug candidates by conducting experiments and analyzing data. You will also collaborate with a dedicated team, documenting findings and presenting them to enhance drug substance processes.

• •
  Enrollment in a Master’s program in life science
• •
  Interest or knowledge in data science, statistical analysis, and basic programming
• •
  Advanced communication skills in English

KI-Beschreibung

In this role, you will actively support the development of innovative drug candidates by conducting experiments and analyzing data. You will also collaborate with a dedicated team, document findings, and present them to enhance drug substance processes.

• •
  Enrollment in a Master’s program in life science
• •
  Interest or knowledge in data science, statistical data analysis, process modeling, simulation, automation, and basic programming
• •
  Advanced communication skills in English

KI-Beschreibung

In this role, you will lead the scientific strategy for developing Biologic Drug Products, overseeing everything from technical activities to regulatory submissions. Your day-to-day responsibilities will involve collaborating with teams, interpreting results, and mentoring junior scientists, all while driving innovative solutions in a dynamic environment.

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  PhD or Master in pharmaceutical technology, biotechnology, chemical engineering, or relevant discipline
• •
  Experience of 2-5 years in biotech/
  pharmaceutical industry with focus on formulation or manufacturing processes development, technical transfer, validation, and submission for biological drug products
• •
  Solid understanding of quality standards and regulations in pharmaceutical industry

Deine Vorteile

KI-Beschreibung

As an Analytical Project Leader, you will drive the analytical development strategy, ensuring timely delivery of high-quality documents while managing a cross-functional team. This role involves engaging with regulatory bodies and supporting team growth, as well as overseeing critical analytics activities in drug development.

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  PhD or university life-science degree with industry experience
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  Minimum of 5 years' experience in managing teams/
  projects
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  Excellent understanding of regulatory expectations and IND/
  BLA submission

Deine Vorteile

KI-Beschreibung

As an Analytical Project Leader, you will drive the analytical development strategy, ensuring timely delivery of high-quality documents while managing a cross-functional team. This role involves engaging with regulatory authorities and supporting the growth of the team, overseeing all analytics activities in drug development.

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  PhD or university life-science degree with industry experience
• •
  Minimum of 5 years' experience in managing teams/
  projects
• •
  Understanding of regulatory expectations and IND/
  BLA submission experience

Deine Vorteile

KI-Beschreibung

In this role, you will drive global CMC regulatory strategies and submissions, ensuring compliance while balancing innovation and business needs. Your day-to-day responsibilities will involve collaborating with project teams, managing documentation, and engaging with health authorities.

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  Science degree or equivalent
• •
  At least 2 years’ experience in regulatory CMC or pharmaceutical industry
• •
  Working knowledge of chemistry/
  biotechnology, analytics or pharmaceutical technology

Deine Vorteile

KI-Beschreibung

In this role, you will drive global CMC regulatory strategies and oversee submission activities, ensuring compliance and quality throughout the product lifecycle. Your expertise will guide interactions with health authorities and support project teams in navigating regulatory challenges.

• •
  Science degree or equivalent
• •
  At least 2 years’ experience in regulatory CMC or pharmaceutical industry
• •
  Demonstrated working knowledge of chemistry/
  biotechnology, analytics or pharmaceutical technology

Deine Vorteile

KI-Beschreibung

In this role, you will be at the forefront of developing user-friendly drug delivery devices. Daily responsibilities include conducting human factors studies, collaborating with diverse teams, and ensuring that products meet regulatory standards while prioritizing the end-user experience.

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  3+ years of experience in human factors engineering, preferably in medical devices or combination products
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  Strong understanding of usability engineering standards (e.g., IEC 62366, ISO 14971)
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  Experience with qualitative and quantitative research methods

KI-Beschreibung

In this role, you will be at the forefront of developing user-friendly drug delivery devices. Your work will involve conducting human factors studies, collaborating with diverse teams, and ensuring that products meet regulatory standards while prioritizing the end-user experience.

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  MSc in Human Factors Engineering, Cognitive Sciences, Behavioral Sciences, Biomedical Engineering, Psychology, Product Design, or Mechanical Engineering
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  3+ years of experience in human factors engineering, preferably in medical devices or combination products
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  Strong understanding of usability engineering standards (e.g., IEC 62366, ISO 14971)

KI-Beschreibung

You oversee quality assurance for Data and Digital projects, ensuring compliance and effective execution. Your role involves leading initiatives, promoting the use of AI, and maintaining communication across teams to enhance quality processes.

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  5+ years of relevant experience
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  Demonstrated experience in project management
• •
  Strong quality background

Deine Vorteile

KI-Beschreibung

You manage quality assurance and compliance initiatives, ensuring adherence to regulations and fostering continuous improvement in clinical programs while addressing quality issues and supporting corrective actions.

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  Functional breadth
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  Critical negotiations
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  Project management

Deine Vorteile

KI-Beschreibung

You manage quality assurance tasks, ensuring compliance with regulations and supporting initiatives to improve quality performance across clinical programs and operational activities.

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  Functional breadth
• •
  Critical negotiations
• •
  Project management

Deine Vorteile

KI-Beschreibung

In this role, you will lead the Site ITOT organization, focusing on enhancing automation and IT processes. Your daily responsibilities will include managing a dedicated team, collaborating with global counterparts, and ensuring operational excellence and compliance.

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  Minimum of 7 years of experience in Automation or IT in a GMP Pharma environment
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  In-depth knowledge of automation systems and IT infrastructure
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  Bachelor's degree in Computer Science, Information Technology, automation, engineering, or related field

Deine Vorteile