Supervisor, Manufacturing (2nd Shift Mon-Fri)

MannKind Corp.; Danbury (CT); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Manufacturing Supervisor for their 2nd shift operations. The role involves overseeing drug product manufacturing, ensuring compliance with regulatory standards, and supervising staff. Candidates should have extensive experience in pharmaceutical manufacturing and a strong understanding of quality standards. This position offers a biweekly stipend for 2nd shift work.

Benefits

Biweekly stipend for 2nd shift

Qualifications

• 12+ years related experience required.
• Experience in writing and implementing SOPs in a GMP environment.

Responsibilities

• Supervise manufacturing floor operations of bulk and semi-finished drug products.
• Ensure compliance with regulatory requirements and company procedures.
• Train new manufacturing associates on bulk processes.

Skills

Process Technologies

Pharmaceutical Quality Standards

SOP Implementation

Education

High School Diploma

AA Degree

BS Degree

Job description

Position Summary:

Supervises downstream related activities and staff responsible for cGMP drug product manufacturing. Responsibilities include supervision of bulk manufacturing shifts, process scale-up, process innovation, scheduling, development activities at the commercial scale, supervision of cGMP operations, troubleshooting, hands-on support during manufacturing batches, and product performance assessment. Responsible for authoring, reviewing, and approving cGMP documents such as SOPs, batch records, deviations, process descriptions, validation protocols, and reports. Collaborates with Quality Assurance, Quality Control, Manufacturing Technical Services, Facilities Engineering, Formulation Research, Process Technology, and Validations.

This is a 2nd shift position, Monday to Friday, with an additional $300 biweekly stipend for 2nd shift.

Essential Duties and Responsibilities:

• Supervise manufacturing floor/line operations of bulk and semi-finished drug products.
• Coordinate support groups for commercial manufacturing.
• Oversee activities to maintain clean room and potent compound facility areas, including manufacturing operations.
• Manage off-shift, PTO, and vacation coverage.
• Train new manufacturing associates on bulk processes.
• Author and revise SOPs and Master Batch Records.
• Investigate and report manufacturing deviations.
• Ensure manufacturing compliance with regulatory requirements and company procedures.
• Coordinate development activities for existing and new product platforms without affecting production schedules.
• Plan short-term manufacturing activities to support the master production schedule.
• Observe all health, safety, and environmental guidelines.

Additional duties may be assigned as needed.

Minimum Qualifications:

• High school diploma with 12+ years related experience or AA degree with 10 years or BS degree with 6-8+ years of manufacturing/supervisory experience.
• Extensive knowledge of process technologies, equipment, and pharmaceutical manufacturing.
• Strong understanding of pharmaceutical quality standards.
• Experience in writing and implementing SOPs in a GMP environment.
• Willingness and ability to wear a respirator and gown in a clean room environment.