Associate II, Manufacturing Operator (3rd shift, 10:00pm-6:30am, M-F)

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.

At MannKind our employees are our number one asset, and we continue becoming a tight-knit community where each of us plays a critical role in our collective success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.

Job family 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. 3rd Shift Hours: 10:00 pm to 6:30am with a 15% Shift Differential

Essential duties and key job responsibilities and essential functions.

• Works on assignments that are semi-routine in nature where some judgment is required in resolving problems and making routine recommendations. Exercises some judgment within defined practices and policies in evaluating criteria for obtaining results.
• May provide guidance on assignments to other lower-level personnel.
• Execute manufacturing operations as required by Manufacturing Records according to Current Good Manufacturing Practices and Standard Operating Procedures in a clean room environment
• Performs manufacturing area and equipment setup, cleanup and teardown and sanitization with supervision
• Operates manufacturing production equipment, under supervision, as required by Manufacturing Records and Standard Operating Procedures
• Performs in-process inspection and testing, under 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 50% of manufacturing equipment.

Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.

Section III: 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/GED with minimum of 3-5 years related experience or the equivalent combination of experience and training. 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).