Manufacturing Associate I

Key Responsibilities

• Author SOPs, batch records and deviations.
• Maintain the ability to aseptically gown and/or sterile gown as needed.
• Perform stocking and inventory of manufacturing supplies.
• Perform cleaning of process equipment and manufacturing suites.
• Ensure training requirements are kept up to date in operations being performed.
• Assemble, clean and autoclave process components and equipment.
• Prepare buffers and solutions following approved processes.
• Perform aseptic operations within Biosafety cabinets and clean room environment.
• Absorb visual inspection of final product vials.
• Follow verbal and written procedures in performing processing steps and operating production equipment.
• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements and accurately completes appropriate production documentation.
• Assist with the review of completed manufacturing documentation.

Other Responsibilities

• Support validation commissioning efforts for manufacturing equipment.
• Assist with routine maintenance of production equipment.

Qualifications

• Minimum of 1 year working in manufacturing positions in a cGMP environment.
• Experience working in one or more functional areas (Cell Culture, Purification of Drug Substance, or aseptic filling of product).
• Experience with single-use manufacturing technologies.
• Strong organizational skills and attention to detail.
• Excellent written and oral communication skills and strong team player.
• Must be experienced with Microsoft Word and Excel.

Benefits

• Medical, dental, and vision insurance.
• 401(k) match.
• Flexible time off.
• Paid holidays including year-end shutdown.