Manufacturing Associate I - Shift B
AbzenaAbout the role
The Manufacturing Associate I will primarily be responsible for performing all aspects of biologics production in a single use facility, including cell vial thaw and inoculum train expansion inside a Bio-Safety Cabinet, operation of wave and stirred-tank bioreactors up to 2000 L, clarification and sterile filtration, and master cell bank fills. In addition, this role will include operation of chromatography skids in conjunction with multi-use and single-use columns, processing intermediates by depth filtration, ultrafiltration and diafiltration, and performing bulk drug substance fills.
Example Plan Shifts/Training Schedule:
- First 2 weeks: 8 hour shifts, M-F
- Next 1-2 months: 10 hour shifts, Mon-Thurs
- After 90 days: 12 hour shifts, Thurs-Sat & Alternating Wednesdays
Schedule is subject to change based on needs.
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 per
Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s