Manufacturing Associate, Plasmid

Asahi Kasei • The Woodlands, TX

180d

About The Position

Bionova is seeking an experienced upstream manufacturing associate to support production by operating and maintaining equipment in the upstream and buffer preparation units. This position involves hands-on work with cell culture, fermentation systems, filtration, and buffer/media preparation processes in a GMP-regulated environment.

Requirements

• BS or MS in Biological Sciences or related disciplines.
• 3+ years of relevant GMP manufacturing experience in bioprocessing.
• Hands-on experience in running bioprocessing equipment (fermentors, centrifuges, and tangential flow filtration systems).
• Experience with single-use process technologies.
• Ability to troubleshoot process failures related to equipment or execution and identify root cause.
• Creative thinker that can identify better and more efficient methods to address issues and gaps.
• Demonstrate ability to work independently and on cross-functional teams.
• Strong attention to detail.
• Effective verbal and written communication skills.
• Enthusiastic learner.

Responsibilities

• Execute GMP plasmid DNA upstream production activities within a GMP environment.
• Prepare and setup fermentors, centrifuges, mixing, filtration systems and Tangential Flow Filtration Skids.
• Weigh and measure raw materials, and prepare media and buffer solutions.
• Follow procedural instructions in standard operating procedures (SOPs), work instructions (WI) and batch records.
• Ensure work follows current Good Manufacturing Practices (cGMP) and Good Documentation Practices (cGDP).
• Maintain accurate and detailed records of all operations.
• Ensure compliance with cGMPs and other regulatory requirements, including safety and quality standards.
• Perform routine equipment maintenance and troubleshooting of bioprocessing equipment.
• Assist in the identification and resolution of equipment issues that arise during production.
• Support manufacturing investigations and non-conformities to products that impact their safety and efficacy.
• Participate in process improvement initiatives to enhance efficiency, yield and product quality.
• Stay current with industry trends and best practices and participate in training program to develop new skills and knowledge.
• Communicate effectively with managers and team members to report production progress, issues, and improvements.

Benefits

• Health benefits at a subsidized rate.
• Healthcare, Dental, and Vision insurance.
• Life Insurance and Disability Program: 100% covered by Bionova.
• Retirement Plan (401K) Up to 8% of Employer Match.
• Paid time off up to two weeks.
• 10 days of Holidays and 5 days of Sick Leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees