Work Location: Middlesex County, Massachusetts

Summary:

Seeking a Manufacturing Technician to support drug product manufacturing and related activities in a cGMP environment. This position involves hands-on work in laboratory and manufacturing settings, with a focus on maintaining quality standards and supporting process improvements.

Responsibilities:

• Support the production of drug products in both laboratory and cGMP manufacturing environments.
• Conduct routine and in-process environmental monitoring activities to ensure compliance with quality standards.
• Contribute to the development and improvement of manufacturing documentation, including batch records.
• Perform maintenance and qualification of equipment used in cGMP and GLP activities.
• Maintain accurate records and documentation in accordance with quality assurance requirements.
• Coordinate logistics for manufacturing and analytical activities, including scheduling and staffing.
• Apply aseptic techniques and support cell expansion and cryopreservation workflows as needed.
• Collaborate with team members to ensure timely execution of manufacturing processes and continuous improvement initiatives.

Qualifications:

• Bachelor’s or Master’s degree in a scientific or engineering discipline with 1-3 years of relevant industry experience.
• Experience in cGMP manufacturing roles, preferably with cell or gene therapy products.
• Proficiency in aseptic technique, cell expansion, and cryopreservation workflows.
• Experience with equipment maintenance or qualification in a cGMP setting is highly desirable.
• Familiarity with electronic quality management systems.
• Strong organizational and time management skills, with the ability to handle multiple tasks.
• Demonstrated ability to maintain detailed and accurate laboratory documentation.
• Ability to work a flexible schedule, including occasional weekends and holidays as needed.
• Meticulous attention to detail in documentation and protocol execution.
• Self-motivated, strong work ethic, and able to deliver high-quality work under tight deadlines in a fast-paced team environment.

Published Category: Manufacturing & Technical Operations