Manufacturing Associate (GMP)

1w1 week ago

AmplifyBio

New Albany, US · Full-time · $48,000 – $68,000

About this role

AmplifyBio is a leading contract research organization offering discovery R&D, preclinical safety, efficacy, toxicology studies, and manufacturing for cell, gene, and mRNA therapeutics. The ecosystem includes ADOC, ASET, and AMEC facilities. AMEC in New Albany, OH provides customizable cGMP suites in a hoteling, CDMO, or hybrid model for advanced therapy manufacturing.

The Manufacturing Associate (GMP) executes manufacturing processes in a GMP-compliant facility specializing in cell and gene therapy production. This role supports operations under senior supervision to produce therapeutic products while ensuring regulatory compliance and quality standards. Daily tasks include cell expansion, transfection, purification, formulation, and fill/finish.

Associates prepare and operate equipment like bioreactors, centrifuges, chromatography systems, and filtration units following safety protocols. They complete accurate documentation such as batch records and logbooks per GMP regulations. Participation in document reviews, deviation investigations, and CAPA activities drives continuous improvement.

Join a growing team in an innovation-rich ecosystem advancing diverse pharmaceutical products across development stages. Contribute to flexible client solutions with full expert partnership unlike typical CDMOs. Play an essential role in quality control through in-process testing and sampling to monitor critical attributes.

Requirements

Knowledge of GMP regulations and compliance requirements in cell and gene therapy manufacturing
Familiarity with SOPs, batch records, and work instructions for bioprocessing
Proficiency in aseptic techniques and cleanroom gowning procedures
Ability to operate laboratory equipment including bioreactors, centrifuges, and chromatography systems
Attention to detail for accurate documentation and data integrity
Basic understanding of cell culture, expansion, and transfection processes
Capability to perform in-process sampling and testing in a GMP environment

Responsibilities

Execute manufacturing processes according to established SOPs, batch records, and work instructions for cell and gene therapy products
Perform tasks related to drug substance and drug product processing, including cell expansion, transfection, purification, formulation, and fill/finish operations
Prepare and operate equipment such as bioreactors, centrifuges, chromatography systems, and filtration units following safety and operational protocols
Complete manufacturing documentation accurately in accordance with GMP regulations, including batch records, logbooks, and equipment usage logs
Participate in the review and revision of manufacturing documents and procedures to ensure compliance and continuous process improvement
Assist in investigations of deviations, non-conformances, and CAPA activities to resolve and prevent quality incidents
Perform in-process testing and sampling to monitor critical quality attributes and parameters