Job Overview
We are seeking a skilled analytical professional to join our team in designing and building a next-generation biotech drug substance manufacturing facility.
Main Responsibilities:
* Execute analytical procedures according to current corporate specifications and cGMPs for maintaining relevant SOPs.
* Benchmark and maintain QCL digital systems in collaboration with site and external Digital teams.
* Report results into a computer storage system (LIMS) and perform testing using automated systems.
* Be involved in the qualification of analytical instruments and their routine maintenance.
* Develop, validate, and verify new methodologies as part of new product introductions or process improvement activities.
* Recognize atypical assay behavior and normally encountered equipment failure.
* Investigate deviations and record any errors encountered as per procedures and training.
* Follow all relevant Environmental, Health, and Safety procedures and be involved in incident investigations as required.
* Maintain an inventory of chemicals and supplies used to perform analytical testing.
* Assist in the training of other personnel and be responsible for full training of other laboratory personnel.
* Ensure adherence to and improvement of safety procedures to protect other personnel and company property.
* Demonstrate a high level of integrity in the performance of work.
* Relate well to other people with whom they come in contact both within and outside of the laboratory area.
* Have knowledge of general scientific methods and be capable of learning and executing new techniques and instrumentation after appropriate training.
* Participate in or lead area or cross-functional continuous improvement projects such as Six Sigma or other appropriate methodology.
Required Skills and Qualifications
* Hons BSc in Analytical Sciences (Chemistry, Biochemistry, Microbiology) with a minimum of 3 years pharmaceutical experience.
* Comprehensive knowledge of quality control operations with an emphasis on techniques such as immunoassays, quantitative PCR, chromatography, capillary electrophoresis, and spectroscopy.
* Proficiency in the use of multiple instrument platforms and associated software applications.
Preferred Skills and Attributes
* Excellent attention to detail in all aspects of work.
* Demonstrated understanding of Data Integrity and its application in a Digital Laboratory.
* Highly competent with computer systems.
* Experience working in cross-functional teams and proven ability in decision-making.
* Demonstrated ability in critical thinking, data analysis, problem-solving, and experience in root cause analysis.
* Strong organizational skills including ability to follow assignments through to completion.
* Self-motivated, positive, and able to work under pressure.
* Flexible and adaptable to meet business needs.
* Excellent interpersonal and communication skills (written and oral).
* Demonstrates a continuous improvement mindset.
* Able to implement changes in technology and business systems/processes.