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