Principal Chemical Analyst

4 weeks ago

Cambridge Cambridgeshire, United Kingdom Mundipharma Full time

At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.

Working within the Analytical Services section of the Quality Department laboratories a Senior Analyst will provide high quality scientific and analytical expertise for a variety of pharmaceutical dosage forms. Execute activities related to process and /or product improvement activities. Ensure manufacturing departments are supported in their day to day operations with relevant deviation and process improvement oversight. Seek out improvement opportunities and make suggestions to management for changes in practice and technical innovation. Act as an Analytical expert on a wide range of projects. Will be expected to develop supervisory skills by undertaking more responsibility for the day to day operation of the laboratory.

Role and responsibilities

  • Lead the execution of analytical method transfers between laboratories. Support and help to develop analytical validation strategies, ensuring all aspects of analytical development and validation are delivered to the required standard of science, quality and regulatory compliance in accordance with agreed timelines.

  • Assist with and ensure Quality Management System processes such as Change Controls, Deviations, CAPAs and Quality Risk management procedures are undertaken and progressed as required.

  • Lead Analytical investigations. Plan, coordinate and conduct laboratory work to support analytical projects, this can be including analysis of raw materials, intermediates and finished products. Record, evaluate and present data generated during laboratory work both internally and by third parties, by applying expert scientific knowledge, demonstrating a practical approach and providing appropriate and innovative solutions.

  • Be proficient and proactive in the use of regulatory and other relevant guidelines, including pharmacopoeias, to ensure appropriate compliance within projects.

  • Provide appropriate and consolidated CMC or pharmaceutical analysis opinion to ensure successful project outcomes.

What you'll bring

  • Minimum 5 years of years of experience in pharmaceutical testing laboratories.

  • Experience with HPLCs is essential.

  • Experience with Dissolution, APIs, tablets, and capsules forms are desirable.

  • Proven track record in analytical chemistry and or analytical development for drug product formulations as well as experience in CMC/regulatory guidelines and filings

  • Significant industrial experience working in or maintaining a GMP/GLP compliant analytical environment.

  • Experience with EU regulatory guidelines, quality management systems and quality risk assessments.

What we offer in return

  • flexible benefits package

  • opportunities for learning & development

  • collaborative, inclusive work environment

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