PLS Associate Scientist II

Pace® Analytical Services•Morrisville, NC

2d•$27 - $32

About The Position

The Associate Scientist II conducts chemistry and biochemistry analyses and may assist with designing and developing robust, scalable formulations for small molecules and biologics for early-stage clinical trials. The role may also support development and optimization of drug-product manufacturing processes and interpret analytical data to inform formulation and process-development decisions. The position performs routine and non-routine testing and analysis using analytical instrumentation, including HPLC and dissolution equipment. It reviews, interprets, and documents results; identifies trends and findings; and presents recommendations to management or clients. The Associate Scientist II follows standard operating procedures and applicable regulatory guidelines and GMP standards, contributes to project objectives, and works with clients, staff, management, and cross-functional teams.

Requirements

Bachelor's degree in chemistry, biochemistry, or a closely related field.
2–5 years of experience, including experience with specialized or technical programs or operations, or an equivalent combination of education, training, and experience.
Knowledge of Empower.
Knowledge of Master Control.
Knowledge of LIMS.
Knowledge of UV-Vis.
Knowledge of dissolution.
Knowledge of HPLC.
Knowledge of GMP.
Knowledge of ALCOA+.
Knowledge of root cause analysis.

Responsibilities

Conduct routine analyses of testing materials, products, and devices using analytical instrumentation and established methods.
Run analytical methods and perform routine and non-routine analyses using instruments such as HPLC and dissolution equipment.
Review, analyze, interpret, and document testing results.
Analyze chemistry, biochemistry, and formulation information to identify trends, draw conclusions, interpret findings, and present results and recommendations to management or clients.
Provide analysis, interpretation, and counsel to clients, staff, management, and functional leaders regarding chemistry and biochemistry policies, programs, and practices.
Participate in chemistry, biochemistry, formulation, or cross-functional project and program objectives, including proposed budgets, timelines, materials, personnel, and other requirements.
Assist with formulation development and optimization and with drug-product manufacturing process development, as needed.
Ensure activities adhere to SOPs, regulatory guidelines, and GMP standards.
Contribute suggestions and participate as an active member of a work team to improve departmental service and effectiveness.
Promote a courteous, cooperative, and effective workplace while supporting Pace Analytical's mission.