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

MannKind Corporation•Danbury, CT

3h•Onsite

About The Position

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. They are committed to using their 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. Their 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, employees are considered the number one asset, fostering a tight-knit community committed to diversity, depending on a rich blend of ideas, backgrounds, and working styles. The Manufacturing Operator executes quality and manufacturing procedures to meet production demands and regulatory requirements, including on-time manufacture of intermediate, semi-finished, and finished pharmaceutical products that meet quality standards. The role assists with establishing equipment operating specifications, standard operating procedures, improving manufacturing techniques, equipment maintenance, calibration, and resolving technical issues.

Requirements

High School/GED with minimum of (0-3 years Associate I) 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).

Responsibilities

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.