Principal Scientist (R5-R7) - Parenteral

Responsible for the analytical development activities in support of Sterile Parenteral pharmaceutical products from CAN stage through commercial filing (including solutions, lyophiles, suspensions, depots).

Works as an integrated partner with scientists in the Parenterals Center of Emphasis. Will also requires good working relationships with colleagues in the Supply Chain, RCMC and PGM.

The primary role of this position is as a Laboratory Supervisor in the ARD Parenterals Project Progression group responsible for the analytical activities of parenteral and ophthalmic (sterile solutions, lyophiles, suspensions, depots) from CAN through to commercial filing. Job responsibilities may include HPLC method development & validation for purity, potency, identity, and performance methods; assessment and testing for leachables and extractables, assessment and testing for particulate matter; Isolation & identification of impurities; Stability & release testing; serving as the single point of contact of accountability on Pharmaceutical Sciences Project teams, including presenting data at team meetings; Critical review of data; Active involvement solving technical challenges that arise during product development; Preparation of technical documents such as test procedures, development reports and stability reports; and Evaluation of new instrumentation or analytical techniques. Job responsibilities may also include the supervision of lab scientists.
REQUIREMENTS
Educational Background
Minimum: BA/BS chemistry related field
Desirable: PhD Chemistry

Work Experience
BA/BS in Chemistry with 7-10 years relevant industrial experience. Working knowledge of relevant physical chemistry (e.g., rheology, colloidal chemistry, etc.) and analytical sciences (chemistry microscopy, thermal analysis, etc.) used for the physical characterization of topical dosage forms is required.

Desirable: PhD in Chemistry with 3-7 years industrial experience in a GMP lab environment with a record of scientific achievement.

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