Aseptic Manufacturing Lead

Aseptic Manufacturing Lead

Position Summary:

The Aseptic Manufacturing Lead plays a critical role in overseeing aseptic manufacturing activities. A strong background in microbiology and experience in aseptic manufacturing are required. The Aseptic Manufacturing Lead will actively participate on the production floor by leading a team of manufacturing professionals and performing aseptic interventions, environmental monitoring, and other microbiology and operational tasks. This role requires strong leadership skills and the ability to collaborate effectively with cross-functional teams. This newly created position offers a unique opportunity to microbiology professionals a non-traditional (outside the lab) pathway to advance rapidly in the pharmaceutical industry by providing a well-rounded manufacturing experience to take on higher level managerial roles in the industry.  

Job Responsibilities:

• Maintain compliance with company policies, cGMP, safety standards, and regulatory requirements.
• Operate equipment on the production line via aseptic technique within a clean room space.
• Troubleshoot and escalate equipment issues when necessary.
• Address and escalate manufacturing, sterility, or quality concerns to the appropriate department leaders.
• Review and participate in manufacturing documentation such as Protocols, Batch Records and Risk Assessments.
• Review and participate in quality event records, such as Change Controls, Deviations, and CAPAs.
• Develop and implement strategies to improve aseptic manufacturing processes.
• Collect required samples needed for testing as required.

• Follow all required work safe practices.
• Hold peers accountable to all required work safe practices.
• Report process deviations to supervisor to mitigate product impact.
• Ensure the integrity of the cleanroom garb during manufacturing activities.
• Ensure personnel are maintaining the integrity of their cleanroom garb during manufacturing activities.

• Ability to wear full cleanroom garb for up to 5 hours at a time.

• Perform personnel monitoring of sterile garbed personnel.
• Perform compressed gas sampling to support manufacturing and/or qualification activities.
• Perform environmental monitoring such as viable air, total particulate air (non-viable), surface (RODAC), and swab sampling to support manufacturing and/or qualification activities.
• Perform aseptic interventions, when necessary, on the operating fill line.
• Participate in qualification activities such as media fills, protocols, and performance qualifications.
• Some part of the job requires working late or night shifts or a Pitman schedule as company needs evolve. The Pitman schedule allows plenty of personal/family time for those willing to embrace the benefits of Pitman schedule. 

• This position may be involved with the transportation and handling of hazardous waste; must successfully complete Resource Conservation Recovery Act (RCRA) training within 1 year of hire, and annually thereafter.

Required Skills:

• Strong understanding of microbiology, aseptic techniques, and manufacturing practices.
• Knowledge of cGMP and pharmaceutical regulations.
• Proven leadership skills.
• Strong communication and interpersonal skills.
• Excellent problem-solving and decision-making skills.
• Ability to multi-task and work under pressure with time constraints.
• Flexibility to adapt to changes in task priority.

Experience and Education Requirements:

• Bachelor of Science (BS) degree in Microbiology, Biology, or related Life Sciences.
• 2 years of experience in aseptic manufacturing within the pharmaceutical or biotech industry.