Manufacturing Associate/Senior Associate - Drug Product - Advanced Therapies

Role Summary

Manufacturing Associate/Senior Associate will perform routine manufacturing activities across GMP manufacturing areas, including cell culture, downstream purification, and fill & finish at the Lebanon Advanced Therapies site. The role initially supports equipment qualification, developing site operations procedures, and setting up production areas during startup; once the plant is operational, you will execute production activities on your shift under the supervision of the shift supervisor.

Responsibilities

• Lead manufacturing teams working in a cleanroom environment to formulate and fill advanced therapies in a safe and quality manner.
• Leverage problem solving skills to evaluate process & protocol deviations real-time and provide assessments to cross functional process teams.
• Apply independent judgement and discretion to execute equipment commissioning and qualification testing and process validation activities under the guidance of the C&Q/validation leads to deliver fully robotic filling process.
• Conduct and appropriately document production of advanced Therapies via strict adherence to digital manufacturing batch records and affiliated SOPs.
• Adhere to all applicable procedures, cGLP, cGMPs, company policies, and any other quality or regulatory requirements.
• Maintain compliance with cleanroom gowning requirements required for completing specific work in drug substance and drug product.
• Apply critical thinking skills to projects outside the manufacturing area, supporting Lebanon Advanced Therapies Manufacturing long-term drug product goals.
• Investigate deviations and implement corrective actions leveraging the local QMS system.

Qualifications

• Required: High School diploma + 5 years of operations experience OR Bachelor's degree in STEM field
• Preferred: Direct manufacturing experience with automatic, manual, and semi-automated equipment, following operational procedures.
• Preferred: Technical problem-solving skills.
• Preferred: Good communications skills (both oral and written).
• Preferred: Requires learning and understanding Good Manufacturing Practices and strict adherence to GMP regulations.
• Preferred: Will be expected to adhere to all safety and environmental guidelines and to promote safety and environmental compliance in all areas.
• Preferred: Good organization skills.
• Preferred: Ability to work with and learn new digital systems
• Preferred: Ability to demonstrate attention to detail
• Preferred: Background in robotics and/or engineering

Additional Requirements

• During the start-up phase of the project, the shift will be primarily day shift. As the site nears normal operation, shift work will be required. Anticipated to be 4 x 10 hour rotating shifts
• Ability to maintain focus on a complex task for 4-6 hours at a time.
• Adaptable to work in a fast-paced and evolving environment.
• Maintain clear, consistent, and constant verbal communication with one or more team members during performance of duties.
• Some overtime required.