Process Development specialist

Job Responsibilities

• Candidate will be running routine samples 

• Executing analyses of routine samples to support commercial programs 

• This person will be in the lab testing 

• Contributes as part of a team of analysts for execution of analytical methods to perform routine sample testing of biological therapeutic product release and characterization testing in a compliance-based environment, following established test methods and protocols. 

• Sets up, operates and maintains laboratory instruments, monitors experiments, makes observations, calculates and records results, and often develops conclusions. Individual is familiar with basic scientific principles and has had some laboratory experience. 

• Can follow written direction and maintain a laboratory notebook. 

• Has good communication skills and is computer literate. 

• A degree, GMP, GLP, FDA, RCRA, and OSHA knowledge may be required. 

• Sample testing and method qualification execution related work and associated work: sample inventory, report generation/documentation, reagent inventory management and equipment maintenance. 

Education & Qualification

• Preferably a BS with documented experience of analytical work for 0-2 years in a biologics industry laboratory. 

• Demonstrated experience of working with HPLC, plate based and gel methods. 

• Preferably experience with one or more of following method: Various Chromatographic Separation Modes, ELISA, SDS-PAGE, Western blot, receptor binding. 

• Proficiency in diverse analytical techniques is required along with basic biochemistry laboratory techniques. 

• Computer competency is essential with emphasis on spreadsheet-based software. 

• Effectiveness will be based on his/her ability to support lab functions and to clearly and accurately document and communicate data in written form and verbally to colleagues as well as superiors. 

• The ability to adhere to strict guidelines when applicable is required. 

• 0-2 years of QC experience

• Recent graduates (with internship experience) are OK 

• Healthcare experience ok as long as they are actively doing QC work 

• Person needs to have laboratory experience (chromatography, bioassays, plate based methods) 

• Preferable a biotech or pharma background 

• Performance will impact inter-department schedules and timelines. 

• Reviews work for technical soundness and accuracy.