Aseptic Manufacturing LeadPosition 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.