Manufacturing Associate I
Core
Assist in the planning, preparation, and execution of laboratory-based activities for the production of cGMP biological material for early Phase Clinical trials.
Role type
Manufacturing Associate I (cGMP biological production)
Builds
cGMP biological material for early Phase Clinical trials
Domain
Biotechnology / Clinical Research / Infectious Disease
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, batch record execution, SOP adherence, media and solution preparation, cleanroom operations (ISO 5), BSL-1/2/3 safety protocols, upstream processing (cell culture), downstream processing (UF/DF, chromatography), fill/finish activities
Preferred skills
cGMP quality system experience, contract manufacturing experience, BSL-2/3 clean room experience
Technologies
cell culture, UF/DF, chromatography
Responsibilities
Execute approved documentation for media and solution preparation; Assist in execution of batch records and SOPs for upstream, downstream, and fill/finish activities; Perform activities in cleanroom environments up to ISO 5; Work within BSL-1, BSL-2, and BSL-3 spaces with biological agents
Seniority
Entry-level (0-1 years experience)
