Senior Laboratory Analyst

Job description

This resource will be expected to lead the implementation process for new laboratory equipment installations within the analytical teams of QC and Analytical R&D (AR&D), utilising support from other departments such as QA, IT and analytical as required, so needs to have specific knowledge of the end-to-end equipment installation and qualification process for analytical instrumentation in a cGMP environment. 

Responsibilities: 

The key responsibilities of the Senior Laboratory Analyst – shall include but shall not be limited to:

·        Lead role in the implementation and qualification of analytical instruments, and in their routine/periodic maintenance.  

·        Develop standard operating procedures, specifications and local analytical methods.

·        Ensure GMP Compliance of laboratory operations and documentation, including testing, write ups, review and approval of protocols, reports and change controls.

·        Publish and analyse reporting results into a computer storage system (LIMS), as well as performing testing using automated systems. 

·        Managing equipment supplier relations, for new equipment and software to be used in the Laboratory

·        Lead and coordinate deviation investigations and record any errors encountered, as per procedures and training. 

·        Establish and maintain internal and external communication with stakeholders from adjacent departments, supporting functions and external vendors.

·        Assist in the training of other personnel and as their level of skill develops, may be responsible for the full training of other Laboratory personnel.

·        Foster and support a culture of growth, enablement and high performance

Basic Requirements: 

·        Minimum BSc (Hons) in Analytical Sciences (Chemistry, Biochemistry, Microbiology) with a minimum of 5 years pharmaceutical experience.   

·        Experience of HPLC/GC testing and set-up for different analytical processes.

·        Experience in a small molecule pharmacology environment.

·        Comprehensive knowledge of quality control operations.

·        Understanding of multiple instrument platforms, vendors and associated software applications.

Additional Skills/Preferences: 

·        Demonstrated leadership competencies by leading a team or department close to QC, QA and/or IT operations.

·        Proven to be an excellent communicator and motivator to drive interdepartmental initiatives.

·        Proven ability to implement changes in operational, technology and business process workflows in a pharmaceutical environment.

·        Demonstrated expertise of Data Integrity/Orchestration and its application in (Pre-) Digital Laboratory Operations.