Associate Principal Scientist- Microbiology

United Kingdom, Slough

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

We are currently looking for an experienced Associate Principal Scientist- Microbiology

to join our Centre of Excellence for biopharmaceutical process development and small-scale GMP manufacturing in Slough, UK.

The Associate Principal Scientist- Microbiology will collaborate with cross-functional teams in defining technical specifications e.g. customer IND submissions, sampling plans, whilst being a main point of contact for external collaborations.

You will also provide technical oversight in microbiological based assays and activities, author and review Batch Microbiological Summary Reports and support in customer discussions in providing strategies or remedial actions for microbiology related testing.

Key responsibilities:

  • Provide SME impact assessments in Trackwise records: Deviations/ Excursions/ Investigations/Change Assessments etc.
  • Develops new biochemical and microbiological methods for testing LONZA products and process samples.
  • Designs protocols for validating existing and new test methods and supervises execution of these protocols.
  • Assists in the transfer of validated methods to the LONZA QC laboratory.
  • Assists in developing and maintaining a schedule for the validation of QC tests for process intermediates and drug substance.
  • Designs protocols for implementation, installation, operation and performance qualifications of rapid methods in QC and maintains the schedule for completing these qualifications.
  • Identifies resources, equipment and supplies that are required to perform implementation and validation of process intermediate and drug substance tests.
  • Maintains system for timely purchase and qualification of laboratory equipment and reagents.
  • Assists the QC department in troubleshooting or investigating instrument and assay problems.
  • Notifies QC management of any potential quality issues related to test validations and provide recommendations for quality improvement.
  • Generates thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-trend events.
  • Participates in regulatory/customer and internal inspections/audits including providing written responses as applicable for area of responsibility.

What we need you to have:

  • Ideally have a MSc. Microbiology, Biology, Biochemistry or closely related scientific discipline is preferred.
  • Equivalency: In lieu of a MSc, candidate must have a Bachelor’s degree and extensive relevant experience in a GMP regulated environment.
  • Familiarity with MHRA, ICH and U.S. / European pharmacopeia guidelines QC Microbiology related topics.
  • Fundamental understanding of microbiological methodologies including but not limited to environmental and water/gas systems monitoring, bioburden and endotoxin testing, organism identification and assessment, media qualification .
  • Must have strong technical writing skills.
  • Ability to work independently with minimum supervision.
  • Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
  • Excellent verbal and written communication skills in the English language.
  • Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
  • Specific experience with LIMS is preferred.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.  

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

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Reference: R39450