Associate Research Scientist - Quality Control - GMP

PPD - Middleton, WI3.4

Full-time
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Associate Research Scientist - Quality Control - GMP - 151068
Description

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offer the most comprehensive set of laboratory services available in the industry. Our services are designed to accelerate pharmaceutical development for small molecules, biologics, and vaccines, allowing our clients to make faster decisions about their compounds.

As an Associate Research Scientist (Biopharmaceutical Services), you are committed to excellence and high quality results in your complex laboratory analysis of key pharmaceutical products. Beyond the bench, you work as a project leader with a strong sense of urgency aligned to our customers, and you are committed to delivering results.

Grow your career within the scientific ladder, pursue project management, or develop into a leader. These are just a few career pathways available once you choose to "Be with PPD".

Join PPD in our relentless pursuit of excellence - apply now!

Responsibilities:
Responsible for the regulatory and scientific conduct of development, validation, stability projects, and/or other specialty technologies such as extractable/leachable studies.
Performs troubleshooting on multiple analytical instrumentation (HPLC, ELISA, CE, iCE, etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.), calculates and interprets data, and records data in adherence with PPD SOPs and any additional requirements specific to the lab and / or client.
Routinely acts as the technical project leader for multiple projects, interacts with clients on a weekly basis (or as needed) to provide updates, reviews and evaluates data, writes reports and protocols.

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Qualifications

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 6+ years) or equivalent combination of education, training, & experience.
OR

Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years)

OR

PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2+ years)
HPLC, ELISA, and/or CE / iCE instrumentation experience, strongly preferred.

Previous regulated laboratory 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
Working Conditions

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.
Physical Requirements

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.
PPD is an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group.

Organization - Biopharmaceuticals
Primary Location - North America-United States-Wisconsin-Middleton - Research Way