Scope of Responsibilities:

• Support manufacturing operations to produce clinical supply products under cGMP conditions in a Lean Manufacturing environment
• Execute routine production activities following batch records, standard operating procedures (SOPs), and work instructions
• Prepare, operate, and clean equipment and manufacturing areas in accordance with established procedures
• Accurately document manufacturing activities in compliance with GMP and company requirements
• Adhere to all safety guidelines, environmental health standards, and quality systems
• Assist with material handling activities, including staging, labeling, and inventory tracking
• Identify, document, and communicate deviations, non-conformances, or safety concerns
• Collaborate with cross-functional teams, including Quality Assurance and Manufacturing Sciences, to support production goals
• Participate in training programs to build technical expertise and maintain compliance qualifications
• Contribute to continuous improvement initiatives and support a culture of operational excellence
• Support manufacturing area readiness for production activities and inspections

Qualifications:

• High school diploma or equivalent required; Associate’s or Bachelor’s degree in Science or Engineering preferred
• 0–2 years of experience in manufacturing, biotechnology, pharmaceutical operations, or a related field (internships or academic lab experience acceptable)
• Basic understanding of GMP and regulated environments preferred
• Strong attention to detail and ability to follow written and verbal instructions
• Effective communication and interpersonal skills
• Ability to work collaboratively in a team environment
• Willingness to learn and grow in a fast-paced, start-up environment

Additional Requirements:

• Ability to work in a cleanroom environment and wear appropriate personal protective equipment (PPE)
• Flexibility to support shift-based operations, including evenings, weekends, or overtime as needed