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

BioCT; Danbury (CT); On-site; USD 80,000 - 120,000; Full time

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.

Skills

HPLC/UHPLC

Analytical testing

cGMP compliance

Data integrity

Education

Bachelor's degree in Chemistry or related

Master's degree (preferred)

Tools

LIMS

Chromatography data systems

Job description

MannKind Corporation focuses on the development and commercialization of innovative therapeutic products and drug delivery devices that address serious unmet medical needs. We apply our formulation and device capabilities to develop convenient treatment options designed to reduce the burden of disease and improve patient care.

Position Overview

This is a fully hands-on laboratory-based individual contributor role. Scientist III, Quality Control (Analytical/Chemical) performs analytical, physical, functional, and device-related testing supporting sterile and non-sterile drug products, including FUROSCIX® Autoinjectors, pre-filled syringes, and dry powder inhalation (DPI) drug products. The role supports development, method transfer, validation, PPQ, commercial release, stability, investigations, and product lifecycle activities.The Scientist III independently executes assigned testing, prepares laboratory solutions and samples, operates and troubleshoots instrumentation, documents and reviews data, leads or supports investigations, and provides direct technical support to Manufacturing, Device Development, Engineering, Validation, Quality Assurance, and Regulatory Affairs.

Key Responsibilities

Hands-On Analytical and Chemical Testing

• 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 applicable techniques such as HPLC/UHPLC, GC, dissolution, UV-Visible spectroscopy, FTIR, Karl Fischer, particle size analysis, laser diffraction, osmolality, pH, conductivity, density, and other compendial or product-specific 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; promptly elevate significant equipment or method issues.
• Review, interpret, calculate, and document analytical data in accordance with cGMP, approved procedures, and data integrity requirements.

FUROSCIX® Autoinjector and Pre-Filled Syringe Testing

• Perform analytical, physical, and functional testing of FUROSCIX® autoinjectors, pre-filled syringes, assembled devices, and associated components.
• Execute applicable 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 in accordance with 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, and lifecycle activities.
• Support investigations involving device assembly, functional performance, component defects, packaging, transportation, and product complaints.

Container Closure Integrity and Package Testing

• Execute or support Container Closure Integrity Testing (CCIT) for pre-filled syringes, sterile drug product containers, and autoinjector container closure systems.
• Execute CCIT method transfer, qualification, validation, troubleshooting, and lifecycle activities.
• Evaluate and document CCIT results and support investigations of integrity failures or atypical results.
• Support qualification and evaluation of primary packaging systems, sterile barriers, and container closure components.

Visual Inspection

• Perform manual or semi-automated visual inspection of sterile drug products and pre-filled syringes for visible particles, cosmetic defects, container defects, fill-related defects, and other specified attributes.
• Support visual inspector qualification and requalification, defect-set development, inspection method studies, and inspection equipment qualification.
• Evaluate defect classifications and trends and support investigations of visual inspection rejects, inspection failures, and atypical defect rates.
• Document inspection results accurately and maintain compliance with approved procedures and inspection conditions.

Method Transfer, Validation, Stability, and Manufacturing Support

• Execute analytical method transfers from development laboratories, contract laboratories, or other manufacturing sites.
• Perform method verification, qualification, validation, robustness, comparability, and equivalency studies and document results in protocols and reports.
• Perform testing supporting engineering batches, registration batches, PPQ, commercial release, continued process verification, and stability programs.
• Provide direct 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 or technical risks to cross-functional stakeholders.

Investigations, Documentation, and Quality Systems

• Lead or support OOS, OOT, deviation, laboratory, method, instrument, device, CCIT, and visual inspection investigations.
• Perform scientifically sound 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 activities as a technical resource.

Qualifications

Required

• 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.

Preferred

• 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.

Physical and Work Environment Requirements

• 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.

Key Competencies

Hands-On Analytical Testing | HPLC/UHPLC | DPI Drug Product Testing | Sterile Drug Product Testing | Autoinjector and Pre-Filled Syringe Testing | CCIT | Visual Inspection | Device Component Testing | Method Transfer and Validation | Stability Testing | Investigations | Technical Writing

Equal Employment Opportunity

MannKind Corporation is an equal opportunity employer. Employment decisions are based on business needs, job requirements, and individual qualifications, without regard to any status protected by applicable law.