MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
Job Summary:
Executes quality and manufacturing procedures in order to meet production demands and regulatory requirements. Responsibilities include on-time manufacture of intermediate, semi-finished and finished pharmaceutical products that meet quality standards. Assists with establishing equipment operating specifications, standard operating procedures and improving manufacturing techniques. Assists with equipment maintenance, calibration and resolving technical issues. May review existing manufacturing operational processes and procedures and provide technical expertise in order to improve production efficiencies. Shift is Monday - Friday from 7:00 am - 3:30 pm
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Essential duties and key job responsibilities and essential functions:
- Works on assignments where considerable judgment and initiative are required in resolving problems and making recommendations. Exercises independent judgment evaluating criteria for obtaining results
- Must have experience working with chemicals and batching.
- May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel
- Executes manufacturing operations as required by Manufacturing Records according to Current Good Manufacturing Practices and Standard Operating Procedures in a clean room environment
- Operates manufacturing production equipment, under little supervision as required by Manufacturing Records and Standard Operating Procedures
- Performs manufacturing area and equipment setup, cleanup, teardown and sanitization with little supervision
- Performs in-process inspection and testing, under little supervision, as required by Manufacturing Records and Standard Operating Procedures
- Accurately and completely documents manufacturing activities in appropriate Manufacturing Records, Controlled Forms, Product Container Labels and Logbooks
- Verifies and documents manufacturing steps performed by other Manufacturing Associates as correct in Manufacturing Records and / or Logbooks
- Responsible for observing all Company, Health, Safety and Environmental guidelines
- Fully qualified and able to operate approximately 75% of manufacturing area equipment
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.
- High School diploma/GED with minimum of 6 - 8 years related experience or the equivalent combination of experience and training
- Experience writing and implementing SOPs in a GMP environment
- Must be willing and able to receive medical clearance to wear a respirator (i.e., Powered Air Purifying Respirator) for entire working shift
- Must be physically able to gown and de-gown (including the use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (i.e., Tyvek jumpsuit)
(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485, European requirements, etc.)
Mannkind Corporation
Jul 18, 2025