Manufacturing Supervisor I/II/III

Job Description

The Manufacturing Supervisor has functional responsibility for any of the aseptic manufacturing operations such as compounding, preparation, filtration, filling and lyophilization, in the SLM, CPA, RM, EXT or Finishing departments.

The primary responsibility of the Supervisor III will be the direct supervision of a specific manufacturing area, generation and review of Standard Operating Procedures and Batch Production Records, and compliance with cGMP through observation, training and auditing.

• Supervise assigned manufacturing operations which might include compounding the various antigens manufactured in the ABU portfolio and reporting operational status to the next level of management and with all affected peers on a daily basis.
• Review and update manufacturing documentation associated with the manufacturing areas.
• Provide cGMP, job tasks, and safety training for personnel in the manufacturing areas.
• Generation, update and maintain area Standard Operating Procedures and BPR’s. Compliance with cGMP through observation, training and auditing.
• Supervise hourly employee performance, including compliance with SOP’s, cGMP’s, and safety regulations.
• Perform deviation investigations related to assigned area of responsibility along with implementing corrective actions to prevent recurrence of such deviations.
• Order production supplies and equipment required to manufacture products.
• Prepare production-monitoring reports and participate in analysis of product cost and budgeting process.
• Interview new employees. Provide coaching and counseling for area personnel. Conduct performance evaluations and set objectives and performance standards for area personnel. Assist next level of management in the implementation of disciplinary action.
• Analyze and make recommendations regarding capital expenditures and efficiency improvements in the manufacturing areas.
• Interact with all supporting departments (ex: Quality Assurance, Maintenance, PIC, etc) to ensure production line problems are dealt with promptly and with appropriate quality considerations.
• Schedule the validation of processes and equipment.
• Ensure that all environmental monitoring limits are maintained in all areas.

In Addition to Above: Supervisor III includes:

• Fully trained in NLT two distinct Manufacturing departments.

Qualifications for All levels:

• Microsoft Word, Excel, and PowerPoint
• Managing conflict and influencing outcomes
• Interpretation of cGMP regulations
• Subject to practices/well defined policy, management reviews results after the fact
• Provides analysis, diagnosis or production tasks which noticeably impact end result
• 20 / 30 Corrected Near-Point Vision required.
• Experience working in clean room environments

Supervisor I (functional expertise)

• Bachelors of Science and 6 months related experience OR Bachelors of Arts and 2 years of related experience, OR No degree and 4 years of pharmaceutical supervisory experience.
• Prior supervisory and pharmaceutical experience desired

Supervisor II (functional expertise)

• Bachelors of Science or Arts and 2 years related experience OR No degree and 4 years of pharmaceutical supervisory experience
• Prior supervisory and pharmaceutical experience required

Supervisor III (SME)

• Bachelors of Science or Arts and 4 years related experience OR No degree and 5 years of pharmaceutical supervisory experience
• Prior supervisory and pharmaceutical experience required