Scientist III, Quality Control (Analytical/Chemical) Sterile Operations

MannKind Corporation•Danbury, CT

1d•$84,000 - $126,000

About The Position

MannKind Corporation is hiring a hands-on, laboratory-based individual contributor to perform quality control testing supporting sterile and non-sterile drug products, including FUROSCIX® autoinjectors, pre-filled syringes, and dry powder inhalation (DPI) products. The role supports development, method transfer, validation, process performance qualification (PPQ), commercial release, stability, investigations, and product lifecycle activities. The Scientist III independently executes assigned testing; prepares laboratory solutions and samples; operates, maintains, verifies, and troubleshoots instruments; documents and reviews data; leads or supports investigations; and provides technical support to Manufacturing, Device Development, Engineering, Validation, Quality Assurance, and Regulatory Affairs. The work involves routine and non-routine analytical, physical, functional, device, container closure integrity, and visual inspection testing. The position also supports manufacturing and validation activities, laboratory quality systems, inspections, and cross-functional technical work. The role is routinely based in analytical laboratories and manufacturing support areas and may require occasional off-shift, weekend, or holiday activities for time-sensitive work.

Requirements

Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline with at least 7 years of relevant experience; or a Master's degree with at least 5 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.
Ability and willingness to routinely perform laboratory testing, instrument setup, sample preparation, documentation, and manufacturing support activities.
Working knowledge of FDA cGMP requirements, USP requirements, ICH guidelines, data integrity principles, and controlled laboratory documentation.
Strong technical writing, investigation, problem-solving, communication, organization, and cross-functional collaboration skills.
Ability to work routinely in analytical laboratories and manufacturing support areas while wearing required personal protective equipment.
Ability to stand or sit for extended periods and perform repetitive laboratory manipulations, sample preparation, and device testing.
Ability to safely handle pharmaceutical materials, laboratory chemicals, glassware, equipment, devices, and test samples in accordance with approved procedures.
Ability to support manufacturing and testing schedules, including occasional off-shift, weekend, or holiday activities when required for time-sensitive testing, validation, investigations, or production support.

Nice To Haves

Hands-on experience testing sterile injectable drug products, pre-filled syringes, autoinjectors, or drug-device combination products.
Hands-on experience with CCIT, visual inspection, device functional testing, component testing, or test equipment qualification.
Experience testing non-sterile DPI drug products, including APSD, DDU, assay, impurities, moisture, particle size, or content uniformity.
Experience supporting PPQ, process validation, design transfer, commercial release, and stability programs.
Experience with electronic laboratory systems, chromatography data systems, LIMS, and statistical or trending tools.
Experience supporting regulatory inspections and responding to analytical, device, or laboratory-related observations.

Responsibilities

Perform routine and non-routine testing of raw materials, packaging and device components, in-process materials, finished drug products, stability samples, validation samples, and investigation samples.
Use analytical techniques including HPLC/UHPLC, GC, dissolution, UV-Visible spectroscopy, FTIR, Karl Fischer, particle size analysis, laser diffraction, osmolality, pH, conductivity, and density, as applicable.
Prepare standards, reagents, mobile phases, buffers, sample solutions, and laboratory controls according to approved procedures.
Operate, maintain, verify, and troubleshoot analytical instruments and laboratory equipment; escalate significant equipment or method issues.
Review, interpret, calculate, and document analytical data in accordance with cGMP, approved procedures, and data integrity requirements.
Perform analytical, physical, and functional testing of FUROSCIX® autoinjectors, pre-filled syringes, assembled devices, and associated components.
Conduct device tests such as break-loose force, glide force, activation force, injection time, delivered volume or dose, dose delivery performance, needle or safety-feature performance, mechanical function, and device assembly verification.
Perform dimensional, attribute, and functional testing of syringe and autoinjector components using approved methods, drawings, specifications, or protocols.
Set up, operate, verify, and troubleshoot device testing equipment and fixtures.
Support device design transfer, analytical method transfer, equipment qualification, process validation, PPQ, commercial readiness, stability, lifecycle activities, and related investigations.
Execute or support container closure integrity testing (CCIT) for pre-filled syringes, sterile drug product containers, and autoinjector container closure systems; support method transfer, qualification, validation, troubleshooting, lifecycle activities, and investigations.
Support qualification and evaluation of primary packaging systems, sterile barriers, and container closure components.
Perform manual or semi-automated visual inspection of sterile drug products and pre-filled syringes for specified particles and defects.
Support visual inspector qualification and requalification, defect-set development, inspection method studies, and inspection equipment qualification; evaluate defect classifications and trends and investigate rejects or atypical defect rates.
Execute analytical method transfers and perform method verification, qualification, validation, robustness, comparability, and equivalency studies; document results in protocols and reports.
Perform testing supporting engineering and registration batches, PPQ, commercial release, continued process verification, and stability programs.
Provide laboratory and on-floor QC support during sterile compounding, aseptic filling, device assembly, DPI manufacturing, packaging, equipment qualification, validation, and investigations.
Coordinate testing priorities and communicate results and technical risks to cross-functional stakeholders.
Lead or support OOS, OOT, deviation, laboratory, method, instrument, device, CCIT, and visual inspection investigations; conduct root cause analysis and develop or implement corrective and preventive actions.
Author and review SOPs, specifications, test methods, protocols, reports, risk assessments, change controls, and technical assessments.
Identify opportunities to improve laboratory safety, compliance, right-first-time execution, testing efficiency, and method robustness.
Support regulatory inspections, customer audits, internal audits, and inspection readiness as a technical resource.
Accurately document visual inspection results and maintain compliance with approved procedures and inspection conditions.