Manufacturing Associate I - Shift B

About the role

We are seeking a Manufacturing Associate I to join our dynamic team at Abzena. With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Responsibilities

• Operate under cGMP manufacturing conditions
• Ensure compliance to training on all activities prior to GMP execution
• Adhere to appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms
• Perform operations in a bio-safety cabinet using aseptic technique and maintain asepsis of all closed container sterile processes
• Setup, operate and maintain bioprocessing equipment including single-use bioreactors up to 2000 L, large scale filtration skids, and automated filling machines and analytical instruments for cell culture such as Nova Bioprofile and Vi-Cell systems
• Perform production activities including thawing of cell stocks, inoculum train expansions, cell culture maintenance in bioreactors, depth and sterile filtration, and master cell bank and bulk drug substance fills
• Setup, operate and maintain bioprocessing equipment including AKTA ready column chromatography skids, FlexAct automation skids, large scale filtration skids, and analytical instruments such as SoloVPE
• Perform production activities including depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills
• Troubleshoot process related issues as they arise
• Inventory manufacturing lab supplies and ensure items are properly stocked
• Participate in batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging
• Maintain cleanroom standards for cleanliness and order
• Work effectively and efficiently in a team environment
• Communicate effectively with clients, supervisors, colleagues, and staff, and provide status of floor operation to leads on a regular basis
• Support multiple projects simultaneously
• Cross-train on various tasks including formulation of media and buffers, and operations to support overall success of the Biologics group
• Review GMP records for completeness, accuracy, and compliance on a daily basis in conformance with regulatory requirements
• Review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation
• Adhere to quality standards set by regulations and Abzena policies, procedures, and mission
• Operate to the highest ethical and moral standards
• Perform additional duties as assigned

Qualifications

• 1 – 2 years cell culture experience in a GMP pharmaceutical/biotech environment role with a technical degree or equivalent combined years of both
• Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities
• A proven ability to confidently compute basic arithmetic operations

Physical Requirements

• Ability to stand for extended periods of time
• Ability to lift 50 pounds in weight
• Use arms, hands and fingers to handle, feel or reach
• Ability to climb, balance, stoop, kneel, crouch, or crawl
• Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus