Performs a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices.
Follows validated or experimental analytical procedures with periodic direct supervision.
Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications.
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 1+ year) or equivalent combination of education, training, and experience.).
Knowledge, Skills and Abilities:
Knowledge of applicable regulatory authority, compendia and ICH guidelines
Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use
Ability to utilize Microsoft Excel and Word to perform tasks
Ability to independently optimize analytical methods
Good written and oral communication skills
Time management and project management skills
Problem solving and troubleshooting abilities
Ability to work in a collaborative work environment with a team
Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
Occasional drives to site locations, occasional domestic travel.
Exposure to biological fluids with potential exposure to infectious organisms.
Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
Personal protective equipment required such as protective eyewear, garments and gloves.
Exposure to fluctuating and/or extreme temperatures on rare occasions.
Ability to work in an upright and /or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
Occasional mobility needed.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
Requires multiple periods of intense concentration.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
Ability to perform under stress.
Ability to multi-task.
Regular and consistent attendance.