PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations.
* Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis with increased independence.
* Performs a variety of 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.
* Enters data into databases and reports.
* Performs self review for own data prior to QC submission.
**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 to 2+ years’) or equivalent combination of education, training, & experience. OR Masters degree
**Knowledge, Skills and Abilities:**
* Demonstrated knowledge of multiple applicable techniques such as: HPLC, GC, MS, Dissolution Testing, Inhalation Testing, Biopharmaceutical Testing, Karl Fischer, UV-Vis, FT-IR, TOC
* Proficient in Microsoft Excel and Word
* Proven ability to interpret data by performing trend analysis
* Proven ability in technical writing skills
* Ability to independently optimize analytical methods
* Proven problem solving and troubleshooting abilities
* Good written and oral communication skills
* Time management and project management skills
* 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.
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