Manufacturing Associate - Biotech - Walkersville, MD

Role Overview:

The Manufacturing Associate will support the production of therapeutic proteins (API) in compliance with cGMP standards. This entry-level role involves executing process steps, adhering to SOPs, monitoring equipment and production processes, performing basic lab work (e.g., pH, conductivity), and maintaining cleanliness of the facility and equipment. The associate will receive close supervision while learning and applying aseptic techniques and good manufacturing practices.

Key Responsibilities:

• 40% - Set up and operate production equipment, perform clean-in-place (CIP) and steam-in-place (SIP) procedures, monitor processes, and complete accurate documentation (both written and electronic) per GMP and GDP guidelines.
• 20% - Achieve qualifications for assigned tasks and keep training records up to date.
• 10% - Perform basic lab tasks such as pH and conductivity measurements, and sampling.
• 10% - Handle material transfers, including movement of raw materials and chemicals within the production environment.
• 10% - Conduct routine cleaning and sanitization of the production area and equipment; support ongoing 6S initiatives.
• 10% - Attend shift handovers, meetings, manage email communications, contribute to projects, and complete other assigned tasks.

Qualifications:

• Minimum: High School Diploma or equivalent
• Preferred: Associate's or Bachelor's degree in a science-related field
• Experience: 0-3 years; prior manufacturing experience is a plus
• Skills: Strong logic, critical thinking, and decision-making ability