Bioconjugate Process Quality Specialist

vor 1 Tag

Visp, Schweiz Lonza Vollzeit

At Lonza, we're shaping the future of life sciences. With a strong foundation in science, our greatest strength lies in talented individuals working together to drive innovation and improve lives.

The Bioconjugate Process Quality Specialist will be part of a team that owns and investigates deviations at our facilities. This role represents the Operations Unit, taking ownership of Deviations which arise; investigating root cause(s), impact/potential impact on product and/or systems, and defining appropriate CAPA(s) as solutions.

Key Responsibilities:

  • Own, investigate, author, and record assigned Deviations.
  • Liaise with Subject Matter Experts (SMEs) and key stakeholders to establish root cause(s) of deviations and potential impact of said deviations.
  • Ensure proper investigation tools are used to systematically define all root causes and contributing factors (e.g., Logic Fault Tree, Defense analysis, Event & Causal Factors chart, Fishbone).
  • Define and agree with SMEs appropriate CAPA(s), and associated Effectiveness Checks.
  • Ensure cGMP compliance and consistency through the investigation process and drive their quality records to completion and closure according to scheduled release times.
  • Support the business through ongoing change and process improvement activities.

Key Requirements:

  • Bachelor degree in chemistry, biotechnology, life science or related field.
  • Previous experience in Deviations and cGMP in a regulated pharmaceutical/API industry is a strong advantage.
  • Knowledge of biotech or bioconjugation manufacturing processes and analytical methods is an advantage.
  • Experience with Human and Organizational Performance & risk management approaches is an advantage.
  • Fluency in English, written and spoken. German is an advantage.
  • Technical writing & presentation/communication skills are key for the role. Demonstrated previous experience is a strong advantage.
  • Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
  • Ability to work with and lead a team of SMEs without formal authority as well as to deliver full projects working independently.

We offer competitive compensation and benefits packages, including an estimated salary range of $90,000 - $120,000 per annum, based on qualifications and experience. Our comprehensive benefits package includes health insurance, retirement savings plans, and paid time off.

Join Lonza, where you'll have the opportunity to work with a global leader in life sciences, driving innovation and improving lives. We're committed to excellence, integrity, and respect for people and the environment. Come grow with us

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