Manufacturing Associate II - Shift

With extensive experience in developing biologics and bioconjugates, Abzena offers 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, ensuring vital medicines reach patients quickly and safely. We are dedicated to quality excellence, driven to bring better treatments to market efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

As a member of the manufacturing team, you will execute daily tasks in strict compliance with manufacturing batch records, SOPs, and Good Manufacturing Practices (GMP). You will take ownership of the production process, facility, and environment to ensure smooth operations and collaborate with QA, MS&T, Facilities, and other departments to support successful and compliant manufacturing activities.

• Operate under cGMP manufacturing conditions.
• Ensure compliance by undergoing training on all activities prior to GMP execution.
• Adhere to gowning procedures required for working in Class 10,000 and Class 100,000 clean rooms.
• Perform operations in a biosafety cabinet using aseptic technique and maintain asepsis of all closed‑container sterile processes.
• Ensure right‑the‑first‑time performance of all process steps.
• Perform production activities including depth filtration, purification by affinity, ion exchange, hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills.
• Escalate 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.
• Conduct activities in support of production schedules as directed by senior staff.
• 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.
• Crosstrain on various tasks including autoclaving assemblies, formulation of buffers, and downstream operations to support overall success of the Biologics group.
• Perform manufacturing and process development activities for projects and products in collaboration with others.
• 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.
• Adjust to a flexible work schedule including weekend work, as needed.
• Perform additional duties as assigned.

• A minimum of 2 years of 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.
• Experience with aseptic handling, including BSC operations to maintain the integrity of sterile systems.
• Knowledge of purification using column chromatography.
• Experience using single‑use technologies, such as tube welding, tube sealing, and disposable systems.
• A proven ability to confidently compute basic arithmetic operations.

• Ability to sit or stand for extended periods of time.
• Frequently lift and or move objects at least 50 pounds in weight.
• Ability to gown aseptically.
• Use arms, hands and fingers to handle, feel or reach.
• Ability to climb, balance, stoop, kneel, crouch, or crawl.
• Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.

$60,000 - $80,000 a year

Non‑Exempt

Abzena is an equal‑opportunity employer committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.