- Responsible for the regulatory and scientific conduct of development, validation, stability projects, and/or other specialty technologies.
- Perform troubleshooting on multiple analytical instrumentation and multiple detection techniques, calculates and interprets data, and records data in adherence with PPD SOPs and any additional requirements specific to the lab and / or client.
- Routinely act as the technical project leader for multiple projects, interact with clients on a weekly basis (or as needed) to provide updates, review and evaluate data, write reports and protocols.
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years) or equivalent combination of education, training, & experience.
- Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years)
- PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
- Previous analytical method development and/or validation experience in large molecule / protein / biologics, strongly preferred
- HPLC, ELISA and/or CE / iCE (capillary electrophoresis) analytical instrumentation experience, strongly preferred.
Knowledge, Skills and Abilities:
- Knowledge of general chemistry and separation science
- Ability to independently perform root cause analysis for method investigations
- Proficiency on technical operating systems
- Proven problem solving and troubleshooting abilities
- Proven ability in technical writing skills
- Time management and project management skills
- Good written and oral communication skills
- Ability to work in a collaborative work environment with a team.
- Ability to train junior staff
- 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.