We are seeking a Manufacturing Associate for the Night shift. In this role, you will be integral to supporting development, clinical, and launch activities within our cutting-edge manufacturing environment. Under general supervision, the Manufacturing Associate will perform operations as outlined in Standard Operating Procedures (SOPs) while adhering to Good Manufacturing Practices (GMP).

Key Responsibilities

• Execute hands-on operations including setup, cleaning, and sanitization of manufacturing equipment.
• Prepare buffers and media in accordance with defined manufacturing procedures (MPs) and SOPs.
• Strictly follow GMP documents (SOPs, MPs) ensuring safety and compliance.
• Monitor critical processes and troubleshoot basic equipment issues as necessary.
• Conduct in-process sampling and operate various analytical equipment.
• Maintain a clean and organized workspace in compliance with safety standards.
• Work in a cleanroom environment, utilizing personal protective equipment (PPE) appropriately.
• Initiate quality reports and assist in drafting and revising SOPs and other essential documentation.
• Identify and implement process improvements for increased efficiency.
• Review documentation for compliance, including equipment logs and batch records.
• Carry out physical tasks required for production operations including lifting, pushing, and standing for extended periods.

Preferred Skills

• Strong mechanical aptitude and experience troubleshooting machinery.
• Knowledge of GMP and regulatory requirements relevant to pharmaceutical manufacturing.
• Familiarity with analytical techniques and lab practices associated with biopharmaceutical production.
• Ability to engage in technical writing and documentation.
• Proficiency in using process control systems.
• Strong team player with the ability to communicate effectively with colleagues.
• Able to work in a fast-paced environment with shifting priorities.

Requirements

Basic Qualifications

• Bachelor’s degree OR
• Associate’s degree and 4 years of experience OR
• High school diploma/GED and 6 years of experience.

Preferred Qualifications:

• Background in Biological Sciences or Engineering.
• Prior experience in a regulated manufacturing environment.
• Understanding of purification processes and biomanufacturing.