Senior QC Scientist: Analytical & Device Testing (Sterile)

MannKind Corporation; Danbury (CT); On-site; USD 90,000 - 130,000; Full time

Job summary

MannKind Corporation (Danbury, CT) 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. You will support method transfer, validation, PPQ, stability, investigations, and lifecycle activities.

The role involves executing, documenting, and troubleshooting testing across multiple QC functions, collaborating with

Qualifications

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline with at least 7 years of relevant experience.
• Hands-on QC analytical experience in a cGMP-regulated pharmaceutical, biotechnology, medical device, or combination-product environment.
• Demonstrated practical experience with HPLC/UHPLC and other analytical or compendial techniques used for drug product testing.
• Experience with analytical method transfer, validation or verification, stability testing, and laboratory investigations.

Responsibilities

• Perform routine and non-routine testing of raw materials, packaging or device components, in-process materials, finished drug products, stability samples, validation samples, and investigation samples based on laboratory workload and business needs.
• Execute analytical testing using techniques such as HPLC/UHPLC, GC, dissolution, UV-Visible spectroscopy, FTIR, Karl Fischer, particle size analysis, laser diffraction, osmolality, pH, conductivity, density, and other methods.
• Prepare standards, reagents, mobile phases, buffers, sample solutions, and laboratory controls in accordance with approved procedures.
• Operate, maintain, verify, and troubleshoot analytical instruments and laboratory equipment; escalate equipment or method issues when needed.
• Review, interpret, calculate, and document analytical data in accordance with cGMP and data integrity requirements.

Skills

Analytical testing

cGMP compliance

Data interpretation

Education

Bachelor's degree in Chemistry

Master's degree (preferred)

Tools

HPLC/UHPLC

GC

Dissolution

Job description

MannKind Corporation (Danbury, CT) 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. You will support method transfer, validation, PPQ, stability, investigations, and lifecycle activities.

The role involves executing, documenting, and troubleshooting testing across multiple QC functions, collaborating with