Overview
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.
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
- 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
- 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.
