Biotech GMP Manufacturing Associate II

Abzena; San Diego (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

Abzena is seeking a GMP manufacturing professional to join the biologics team in San Diego. You will execute daily tasks in strict GMP compliance, own the production process, and collaborate with QA, MS&T, Facilities, and others to support compliant manufacturing activities.

The role requires 2+ years in GMP biotech/pharma, aseptic handling experience, and knowledge of purification using chromatography. Flexible shifts and cross-functional teamwork are expected to ensure quality, traceability,

Qualifications

• Minimum 2 years in GMP pharmaceutical/biotech environment with a technical degree or equivalent.
• Knowledge of cGMPs and how they apply to responsibilities.
• Experience with aseptic handling, including BSC operations to maintain sterile systems.
• Knowledge of purification using column chromatography.
• Experience using single-use technologies, such as tube welding, tube sealing, and disposable systems.

Responsibilities

• Operate under cGMP manufacturing conditions.
• Ensure compliance to training on all activities prior to GMP execution.
• Adhere to gowning procedures for Class 10,000 and Class 100,000 cleanrooms.
• Perform operations in a biosafety cabinet using aseptic technique and maintain asepsis of all closed container sterile processes.
• Ensures right-the-first-time performance of all process steps.
• 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.
• 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.
• Support multiple projects simultaneously.
• Crosstrain on various tasks including autoclaving of 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.

Skills

GMP manufacturing

Aseptic processing

Column chromatography

Single-use tech

BSC operations

Education

Technical degree in biotech/pharma

Job description

Abzena is seeking a GMP manufacturing professional to join the biologics team in San Diego. You will execute daily tasks in strict GMP compliance, own the production process, and collaborate with QA, MS&T, Facilities, and others to support compliant manufacturing activities.

The role requires 2+ years in GMP biotech/pharma, aseptic handling experience, and knowledge of purification using chromatography. Flexible shifts and cross-functional teamwork are expected to ensure quality, traceability,