Supervisor, Manufacturing (2nd Shift Mon-Fri)

BioCT Innovation Commons; Connecticut; On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a dedicated Supervisor for their manufacturing team. This role involves overseeing cGMP drug product manufacturing, ensuring compliance with quality standards, and leading a team of skilled associates. You'll be responsible for authoring essential documentation, managing production schedules, and maintaining a clean and safe working environment. If you have a passion for pharmaceutical manufacturing and a proven track record in supervisory roles, this is a fantastic opportunity to make a significant impact in a collaborative and innovative setting.

Benefits

Biweekly Shift Stipend

Health and Safety Training

Career Development Opportunities

Qualifications

• 12+ years of manufacturing/supervisory experience or equivalent education.
• Extensive knowledge of pharmaceutical manufacturing processes and equipment.

Responsibilities

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

Skills

Pharmaceutical Manufacturing

SOP Development

Process Technologies

Quality Standards

Education

High School Diploma

Associate's Degree

Bachelor's Degree

Job description

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

Position Summary:

Supervises downstream activities and staff responsible for cGMP drug product manufacturing. Responsibilities include supervising bulk manufacturing shifts, process scale-up, process and equipment development support, troubleshooting, hands-on support during commercial batches, and assessing product performance. The role involves authoring, reviewing, and approving cGMP documents such as SOPs, batch records, deviations, process descriptions, validation protocols, and development reports. Collaboration with Quality Assurance, Quality Control, Manufacturing Technical Services, Facilities Engineering, Formulation Research, Process Technology, and Validations is essential.

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

Essential Duties and Responsibilities:

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

Additional duties may be assigned as necessary.

Minimum Qualifications:

• High school diploma with 12+ years of manufacturing/supervisory experience, AA degree with 10 years, or BS degree with 6-8+ years.
• 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 receive medical clearance to wear a respirator during shifts.
• Physical ability to gown and de-gown in clean room environments, including using decontamination showers.