Learning Lead, Aseptic Processing

About the role

This position is responsible for leading technical training initiatives for staff engaged in aseptic processing within sterile compounding facilities. The role demands a thorough understanding of aseptic techniques, cleanroom procedures, and regulatory compliance standards relevant to sterile compounding. The successful candidate will develop, implement, and oversee comprehensive training programs to ensure staff proficiency and adherence to industry regulations. Collaboration with Quality Assurance, Operations, and Regulatory Compliance teams is essential to maintain high standards of sterile processing and documentation. The role involves on-site engagement, with a focus on maintaining a safe, compliant, and efficient sterile environment through effective training and continuous improvement.

Key facts

What you'll do

• Create, develop, and deliver detailed training programs covering aseptic techniques, cleanroom conduct, gowning procedures, sterilization processes, visual inspection, and sterile compounding practices.
• Conduct hands-on, practical training sessions for new hires and existing staff, evaluating their performance in simulated environments as well as in live sterile compounding settings.
• Manage ongoing competency assessments, including periodic retraining, to ensure staff remain compliant with regulatory standards and internal procedures.
• Collaborate closely with Quality Assurance and Operations teams to identify training gaps, develop corrective education plans, and implement updates to training materials.
• Develop, review, and update standard operating procedures (SOPs), competency checklists, and documentation related to aseptic simulations, media fills, and validation activities.
• Maintain accurate, complete, and compliant training records, ensuring documentation aligns with FDA 503A/503B and USP guidelines.
• Stay informed about changes in industry regulations, standards, and best practices, and incorporate these updates into training modules to ensure ongoing compliance.
• Prepare for internal and external audits by ensuring all training documentation, records, and validation activities are up-to-date, accessible, and compliant with regulatory requirements.
• Monitor sterile compounding activities in the work environment to observe adherence to protocols, identify potential contamination risks, and recommend process improvements.
• Support the development of a culture of quality and compliance by promoting best practices, safety, and continuous learning among staff.
• Assist in the validation of aseptic processes, including media fills and environmental monitoring, by providing training and oversight.
• Serve as a subject matter expert on aseptic processing, providing guidance and mentorship to staff and other team members.
• Participate in cross-functional meetings to align training initiatives with operational goals and regulatory expectations.
• Contribute to the design and implementation of training metrics and KPIs to measure effectiveness and identify areas for improvement.
• Support the onboarding process for new employees by providing comprehensive initial training and orientation on aseptic procedures.

Requirements

• High school diploma, GED, or equivalent qualification.
• Active Certified Pharmacy Technician (CPhT) certification is required.
• Minimum of 5 years of direct experience in sterile pharmaceutical manufacturing, 503B outsourcing facilities, or 503A pharmacy compounding involving aseptic processing duties.
• At least 3 years of experience in training and evaluating personnel involved in aseptic processing or sterile compounding.
• In-depth knowledge of USP <797>, USP <800>, current Good Manufacturing Practices (cGMP), and FDA 503A/503B regulations as they relate to training and aseptic procedures.
• Demonstrated understanding of cleanroom protocols, contamination control measures, gowning procedures, sterilization techniques, and documentation practices.
• Proven ability to facilitate engaging training sessions, communicate complex technical information clearly, and adapt training methods to diverse audiences.
• Experience in creating and maintaining training SOPs, competency checklists, and validation programs such as media fills.
• Strong organizational skills to manage training records, documentation, and compliance activities efficiently.
• Excellent interpersonal and communication skills, with the ability to teach and mentor staff effectively.
• Flexibility to work day or night shifts as needed to support a 24/7 pharmacy operation.
• Ability to work on-site in Menlo Park, California, and to support the operational needs of the sterile compounding environment.

Nice to have

• Bachelor's degree in a scientific, pharmaceutical, or related field.
• Additional certifications related to sterile processing, quality assurance, or regulatory affairs.
• Experience working in a regulated pharmaceutical or healthcare environment with ITAR considerations.

Skills & tools

• Aseptic technique
• Cleanroom operations
• Sterile compounding
• Gowning procedures
• Sterilization processes
• Visual inspection techniques
• USP <797> and USP <800> standards
• cGMP compliance
• FDA 503A/503B regulations
• Good Documentation Practices (GDP)

Practical notes

This is an onsite position based in Menlo Park, California. The role involves working directly within sterile compounding facilities to ensure staff are trained to the highest standards of aseptic technique and regulatory compliance. Benefits include a competitive salary and equity, unlimited paid time off (PTO), company holidays, and quarterly mental health days. The company offers comprehensive health benefits, parental leave, an Employee Stock Purchase Program (ESPP), a 401k plan with employer matching, and offsite team retreats. The organization is committed to fostering a diverse workforce and provides reasonable accommodations for individuals with disabilities. The position requires active engagement in sterile environments, with a focus on maintaining compliance, safety, and operational excellence through effective training and ongoing support.