Manager Commercial Manufacturing 2nd Shift Mon-Fri 230pm-11pm
Manager Commercial Manufacturing 2nd Shift Mon-Fri 230pm-11pm
Posted on :
11-04-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
11-04-2025
Job Description
MannKind
MannKind Corporationfocuses 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 drypowder 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.
MannKind Corporationfocuses 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 drypowder 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.
This is a 2nd Shift opening. Monday to Friday 2:30pm to 11pm.
Job Summary:
Responsible for managing the successful of activities related to the cGMP manufacturing of pharmaceutical compounds in support of the companys business objectives. Manages downstream related activities and staff responsible for cGMP drug product manufacturing. These responsibilities include but are not limited to bulk drug manufacture filling and packaging and final patient kit assembly as well as innovating novel approaches to improve production efficiency oversight of cGMP operations troubleshooting production challenges and assessing product performance. Executes against and authors reviews and approves various cGMP documents such as standard operating procedures batch records process descriptions deviations investigations validation protocols and development protocols / reports as required. Acts as on the floor supervisor across all unit operations as necessary to cover Manufacturing Supervisor PTOs which may include working overnight shifts. Collaborates with Quality Assurance Quality Control Technical Manufacturing Services Facilities Engineering Formulation Research Process Technology EH&S and Validations.
Essential duties and key job responsibilities and essential functions.
- Manage the daytoday activities of a commercial manufacturing group specifically focused on the evening and overnight shifts.
- Provides technical expertise and resources for the validation of both equipment and process.
- Ensure compliance with all appropriate Federal Drug Administration (FDA) and other regulatory agency guidelines.
- Develop review and revise SOPs and batch records to support GMP manufacturing.
- Collaborates with Quality to ensure that all products are manufactured according to specifications and are released in a timely manner.
- Provide commercial manufacturing input into failure investigations deviations and CAPAs.
- Supervise employees responsible for performance reviews and employee development. Participates in recruiting and training of new employees.
- Responsible for observing all Company Health Safety and Environmental guidelines.
- Supervise manufacturing floor/line operations of bulk and semifinished drug product as necessary to cover Manufacturing Supervisor PTOs. This may include working the overnight shift.
- Manage departmental activities to maintain Commercial Manufacturing Clean Room and Potent Compound Facility Areas including participation and overseeing manufacturing operations
- Short term planning of bulk and fill/pack manufacturing activities to support master production schedule
- Duties and responsibilities are not limited to the work listed above and may include other assignments
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 with 12 years related manufacturing / supervisory experience or AA degree with 10 years or BS degree with 68 years
- High level of knowledge with process technologies equipment and manufacturing of pharmaceutical drug products.
- Strong knowledge of pharmaceutical quality standards.
- Experience writing and implementing SOPs in a GMP environment.
- Experience supervising/managing manufacturing operations.
- Familiarity with performance metrics and the capacity to act on facts
- Excellent written and verbal skills and the ability to communicate clearly concisely and effectively
- 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 degown (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).
Required Experience:
Manager
Employment Type
Part-Time
Key Skills
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