Manufacturing Associate - Microbiology

Abzena Inc.•Bristol, PA

1d•Onsite

About The Position

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 Manufacturing Associate â Microbiology and Manufacturing is responsible for executing cGMP bioconjugation and chemistry manufacturing activities while performing routine microbiological testing to support process control and product quality. This role operates at the interface of Manufacturing and Microbiology. The associate is responsible for maintaining microbial control of the process through in-process testing, environmental awareness, and disciplined GMP execution. The role ensures that manufacturing operations are performed safely, on time, and in compliance with cGMP requirements while supporting microbiological monitoring and testing activities required for product release and process assurance.

Requirements

BS or MS in Microbiology, Biology, Biochemistry, or related field
0-3 years of experience in cGMP manufacturing
Prior supervisory experience required
Strong troubleshooting ability for process and equipment issues
Ability to manage multiple priorities in a fast-paced environment
Ability to stand or walk for extended periods
Ability to lift up to 50 pounds
Ability to work on the manufacturing floor for the duration of shift

Nice To Haves

Experience with Lean manufacturing or Six Sigma preferred

Responsibilities

Works in a cGMP environment and ensures compliance with all regulatory and internal requirements
Executes all activities in accordance with SOPs, batch records, and data integrity standards
Maintains strong documentation practices aligned with GDP and cGMP expectations
Performs bioconjugation and chemistry manufacturing operations
Executes buffer preparation, material handling, filtration, and process steps per batch records
Performs equipment and room setup, operation, and cleaning
Supports manufacturing activities across multiple suites and processes
Monitors process performance and escalates issues impacting safety, quality, or schedule
Performs routine microbiological testing to support manufacturing operations
Performs environmental monitoring (EM) support, including viable air and surface sampling as required
Ensures proper handling, incubation, and documentation of microbiological samples
Maintains chain of custody and traceability of all microbiological samples
Applies contamination control principles during all manufacturing and sampling activities
Ensures proper cleaning and disinfection practices in manufacturing areas
Identifies and escalates potential contamination risks or abnormal microbiological results
Maintains awareness of facility and process conditions that may impact microbial control
Supports batch release by completing and reviewing batch-related environmental monitoring forms and associated documentation
Ensures accuracy, completeness, and traceability of EM data linked to each batch
Coordinates with QA to ensure timely availability of microbiological and EM data
Identifies gaps or discrepancies in EM documentation and escalates prior to batch disposition
Supports compilation of manufacturing and microbiology data required for batch record review and release
Completes batch records, EM related records, and logbooks accurately and in real time
Initiates deviations and supports investigations, including microbiological events
Provides input into CAPAs related to contamination or process performance
Supports review and update of SOPs, batch records, and test methods
Supports operation and cleaning of manufacturing and microbiology-related equipment
Performs routine maintenance support and troubleshooting activities
Works cross-functionally with Quality Control, QA, MSAT, and Engineering
Coordinates sample submission and testing timelines with QC or Qualified Vendor
Communicates microbiological results that may impact manufacturing decisions
Completes all required GMP and microbiology-related training
Maintains qualification for manufacturing and microbiological testing activities
Supports training of other associates as needed