Position Responsibilities:
The scientist filing this position will serve as the primary technical lead for cellbased potency platebased assays qPCR ELISA and working with master cell banks. Work will be conducted in a cGMP testing environment.
The candidate will be responsible for general laboratory and operational support including:
- Execute and analyze data from experiments
- Compile raw data perform data trending and write detailed comprehensive summary reports of assay development and quality control activities
- Provide support in document and SOP review data entry and data analysis
- Ensure general maintenance of the laboratory equipment and inventory
- Ensure proper and timely completion of testing and tasks as assigned
- Revise test methods or equipment SOPs raw material specification and/or sample plans as appropriate
- Identify and facilitate continuous improvements in QC laboratory and systems
- Maintain instrumentation and supporting documentation in a cGMP compliant manner
- Assist in the implementation of new assay methodologies and the associated instrumentation
- Identify and support initiation and completion of deviations CAPAs and laboratory investigations
Qualifications :
- Bachelors degree in chemistry biology biochemistry or related degree concentration and a minimum of 5 years of laboratory experience masters degree with a minimum of 2 years of laboratory experience.
- Good dexterity; positive attitude; solution driven; good work habits (organized efficient careful safetyconscious accurate); attention to detail; sound scientific logic; good oral and written communication skills; understanding of multiple instrumentation platforms; client service focused; demonstration of organizational skills; ability to independently work on complex projects; ability to multitask; technical writing skills
- Industry experience with cell based laboratory testing preferably in a GLP/ cGMP environment
- Industry experience with cellbased Potency qPCR ELISA and working with master cell banks
- Proficient with Aseptic technique
- Possess a basic understanding of instrument installation maintenance and qualification in a GxP environment.
Additional Information :
Position is fulltime first shift Monday Friday 8:00am 5:00pm.
Candidates currently living within a commutable distance of Portage MI are encouraged to apply.
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Fulltime