Work Location: Middlesex County, Massachusetts

Summary:

The Manufacturing Associate is responsible for performing daily cGMP manufacturing activities, including fermentation, harvest, lyophilization, media/buffer production, drug product processing, and maintaining operational readiness. This role requires attention to detail, adherence to safety and quality standards, and the ability to work collaboratively in a fast-paced environment. The position operates primarily on third shift (11:00PM - 7:30AM, Monday-Friday), with occasional off-shift, holiday, or weekend work as needed.

Responsibilities:

• Prepare products accurately by following approved batch records and standard operating procedures.
• Document all activities in batch records, logbooks, forms, and electronic systems with precision.
• Maintain high standards of workplace safety and product quality at all times.
• Operate production equipment and perform processing steps according to written and verbal instructions, ensuring proper documentation.
• Identify, escalate, and document deviations or variances from normal operations, and participate in investigations as needed.
• Troubleshoot basic mechanical operations and support continuous improvement initiatives.
• Comply with environmental, health, and safety programs, as well as gowning and materials movement procedures.
• Support suite and operational readiness activities, and perform other duties as assigned to meet manufacturing needs.

Qualifications:

• High School diploma, Technical Degree, or B.S. in Biology or related field preferred.
• Experience with operational excellence programs (such as 6S) is a plus.
• Familiarity with SOP, MBR, deviations, and CAPA authoring/editing is advantageous.
• Proficiency in Microsoft Outlook, Word, and Excel required.
• Strong laboratory skills and excellent record keeping, including Good Documentation Practices (GDP).
• Ability to work independently and remain focused in a fast-paced environment with minimal supervision.
• Flexibility to support off-hours processing, including early mornings, evenings, holidays, and weekends as needed.
• Excellent written and verbal communication skills, detail-oriented, and strong mechanical/analytical abilities.
• Basic math skills and ability to understand and execute written or verbal instructions in English.
• Ability to handle multiple tasks, work collaboratively, and maintain reliable attendance and performance.
• Physical ability to stand, sit, walk, climb, balance, stoop, kneel, crouch, crawl, and lift/move up to 50 pounds.
• Vision requirements include close vision and ability to adjust focus; ability to communicate via telephone and email.
• No travel required; cleanroom-based position with some non-standard working hours.

Published Category: Manufacturing & Technical Operations