Sterile QC Scientist: Analytical & Device Testing

BioCT

Danbury (CT)

On-site

USD 80,000 - 120,000

Full time

7 days ago

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Job summary

MannKind Corporation is seeking a Scientist III, Quality Control (Analytical/Chemical) to perform analytical, physical, functional, and device-related testing for sterile and non-sterile drug products, including FUROSCIX autoinjectors and pre-filled syringes.

The role involves development support, method transfer, validation, PPQ, commercial release, stability, investigations, and lifecycle activities, with close collaboration across Manufacturing, Device Development, Engineering, Validation,

Qualifications

Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering or related field with relevant experience.
Hands-on QC analytical experience in a regulated pharmaceutical or device environment.
Experience with HPLC/UHPLC, analytical method transfer, validation or verification, and investigations.

Responsibilities

Perform routine and non-routine analytical testing of materials and drug products.
Operate, troubleshoot, and maintain analytical instruments and lab equipment.
Lead or support investigations and ensure data integrity and compliance.
Support device testing, PPQ, stability, and lifecycle activities.
Coordinate testing priorities and communicate results to stakeholders.