Manufacturing Lead - Shift A

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The Lead, Manufacturing Operation sis responsible for serving as the subject matter expert and operational lead within GMP manufacturing operations supporting biologics production. This role provides day‑to‑day direction, all leadership, coordination, and training for manufacturing personnel involved in upstream and downstream processing activities, including cell culture expansion, bioreactor operations, harvest, purification, filtration, and bulk drug substance manufacturing. The Lead supports batch execution, training, process troubleshooting, documentation review, and operational readiness activities.

The Lead, Manufacturing Operations will primarily be responsible for manufacturing operations of Train
2. Train 2 is a production line going from vial thaw in initial thaw and expansion to a 500L production reactor, followed by harvest, to finishing operations in downstream.

• First 2 weeks: 8 hour shifts, M-F
• Next 1-2 months: 10 hour shifts, Mon-Thurs
• After 90 days: 12 hour shifts, Sun‑Tues & Alternating Wednesdays

Schedule is subject to change based on needs.

• Provide hands‑on training for upstream staff to ensure compliance with training on all activities prior to GMP execution.
• Adhere to appropriate gowning procedures required for working in Class 10,000 and Class 100,000 clean rooms.
• Perform operations in a bio‑safety cabinet using aseptic technique and maintain asepsis of all closed container sterile processes.
• Perform upstream 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.
• Monitor processes and results and troubleshoot issues as they arise to ensure process success.
• Lead and guide associates through process and workflow improvement initiatives.
• Lead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging.
• Setup, operate and maintain downstream bioprocessing equipment including AKTA ready column chromatography skids, Flex Act automation skids, large scale filtration skids, and analytical instruments such as SoloVPE.
• Perform downstream 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.
• Enforce cleanroom standards for cleanliness and order
• Direct floor operations for multiple projects simultaneously.
• Make adjustments as necessary to adhere to production schedules.
• Cross‑train on various tasks including autoclaving of assemblies, formulation of buffers, and Downstream operations to support overall success of the Biologics group.
• Represent departmental activities as needed, including project teams and task forces.
• Review GMP records for completeness, accuracy, and compliance on a daily basis in conformance with regulatory requirements.
• Draft, revise and 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.
• Adjust to a flexible work schedule including weekend work, as needed.
• Perform additional…