Stability Analyst Full Time

Cambridge, Cambridgeshire
Mundipharma
Job Title: Stability Analyst

Location: Science Park, Cambridge (Lab based)

Job Purpose

The Analyst is a competent analyst who will provide practical, analytical support within the QC, Stability and Analytical services laboratories, which involves testing intermediate and finished products manufactured at Cambridge and other contract manufacturers with reference to product release testing, shelf-life monitoring, process and method validation. Ensuring that all activities are undertaken in compliance with company standard operating procedures.

Key Responsibility

• To carry out the analysis and testing of the Company’s pharmaceutical products and CMO products where applicable, using a variety of analytical techniques (HPLC, Dissolution, Karl Fischer, wet chemistry techniques) and software packages (LIMS, Empower, Tiamo, Lab-X, Excel).
• Carries out peer to peer data review of analytical data on appropriate LIMS and documentation systems where applicable.
• Maintains accurate, clear and concise written records of all work undertaken, following the analytical methods and making sure all the correct documentation is reviewed and present within the analytical write up, to ensure compliance against registered methodologies and adherence to data integrity. Will Identify OOS results and assisting in investigations.
• Has a good understanding of and ensures that all activities are undertaken in compliance with company standard operating procedures (SOP’s), Good Laboratory and Manufacturing Practice (GxP) and Health and Safety in the workplace regulations

Qualifications

• A level/ONC/HNC
• Graduate with a Degree in Chemistry, Pharmacy, Biology or similar scientific area or equivalent knowledge through experience.
• Experience working in an Analytical Pharma laboratory
• An analytical chemist, with a background in all or some of the following activities. Method development/validation, method transfer, routine QC and Stability processes.
• Competent in key analytical techniques e.g. HPLC, Dissolution, KF, Assay and Related substances.
• Competent in using key departmental software packages such as LIMS, Empower, Word and Excel,
• Works at a good pace, able to prioritise and time manage effectively.
• Knowledge of the manufacture of the products tested and the key attributes of the raw materials in the formulations.
• Report writing, Statistical analysis and data presentation
• Has a good understanding of GMP, Health and Safety, laboratory instrumentation and laboratory practices.
• Membership of the Royals Society of Chemistry (RSC status) or equivalent is desirable

What we offer in return

• flexible benefits package
• opportunities for learning & development
• collaborative, inclusive work environment

Diversity and inclusion

Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do, as we focus on making a positive difference for our customers and their patients.

About Mundipharma

Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe debilitating disease areas. Our guiding principles, centered around Integrity and Patients-Centricity, are at the heart of everything we do.

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Additional Job Description:

Primary Location:
GB Cambridge
Job Posting Date:
2024-08-28
Job Type:
Permanent