Learning Lead, Aseptic Processing

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results.

About the Role

Hims & Hers is seeking a highly experienced Learning Specialist, Aseptic Processing to lead technical training and development for aseptic processing personnel within our sterile compounding facilities. This role is the subject matter expert for aseptic technique, cleanroom operations, and sterile compounding compliance — partnering closely with Quality Assurance, Operations, and Regulatory Compliance to maintain the highest standards of product integrity and patient safety. The Learning Specialist, Aseptic Processing brings deep technical expertise and a proven track record in hands-on training, competency evaluation, and regulatory readiness. This role reports to the Learning team and maintains close collaboration with Quality and Compliance leadership.

Responsibilities

• Develop, deliver, and continuously improve comprehensive training programs for aseptic technique, cleanroom behavior, gowning, sterilization, visual inspection, and compounding procedures.
• Conduct hands-on training and competency assessments for new hires and experienced staff in both simulated and live sterile compounding environments.
• Lead ongoing competency evaluations and retraining initiatives to ensure continuous compliance with regulatory standards and internal SOPs.
• Collaborate with Quality Assurance and Operations to identify training-related root causes, and implement corrective actions through targeted education.
• Develop and maintain training SOPs, competency checklists, and aseptic simulation and media fill validation documentation.
• Maintain up-to-date training records and documentation in compliance with FDA 503A/503B requirements and USP guidelines.
• Stay current on regulatory changes and integrate new industry best practices and standards into training curricula.
• Support audit readiness by ensuring all training documentation is complete, accessible, and inspection-ready.
• Maintain floor presence in sterile compounding environments to monitor compliance, identify gaps, and support continuous improvement.

Requirements

• High school diploma, GED, or equivalent required; Bachelor's degree in a scientific, pharmaceutical, or related field preferred.
• Active CPhT (Certified Pharmacy Technician) certification required.
• Minimum 5 years of direct experience in sterile pharmaceutical manufacturing, 503B outsourcing facilities, or 503A pharmacy compounding environments with hands-on aseptic processing responsibilities.
• Minimum 3 years of experience in training and evaluating aseptic processing personnel or sterile compounding staff.
• Deep understanding of USP <797>, USP <800>, cGMP, and FDA 503A/503B regulations and their application to training and competency programs.
• Proven expertise in cleanroom protocol, contamination control, gowning, aseptic techniques, and compounding documentation practices.
• Strong facilitation and presentation skills with the ability to engage diverse audiences.
• Familiarity with regulatory compliance, training documentation, and Good Documentation Practices (GDP).
• Experience developing training SOPs, competency checklists, and aseptic simulation and media fill validation programs.
• Strong communication skills with the ability to teach complex technical topics to diverse audiences.
• Flexibility to work day or night shift as needed to support a 24/7 pharmacy operation.

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats