GMP Cell Manufacturing Associate
Company: BioRestorative Therapies, Inc.
Location: Melville
Posted on: May 10, 2022
|
|
Job Description:
We are looking for a friendly, well organized, highly motivated
individual to join the manufacturing team at BioRestorative
Therapies. The candidate will work in a dedicated laboratory as
part of a team focused on the production of clinical grade cell
banks and support manufacturing for BioRestorative's lead clinical
candidate, BRTX-100.
We are looking for a team-oriented person who can take on
increasing responsibilities as BioRestorative continues its high
growth trajectory. Primary Responsibilities --- Process human
primary materials for the isolation of MSC's --- Perform cell
culture activities to expand MSC's and manufacture cell banks ---
Perform manufacturing activities for the formulation, filtration
and fill of custom media --- Use good documentation practices to
execute process batch records --- Collaborate with internal
development team for the technical transfer of new products into
manufacturing --- Draft, review and update SOP's and manufacturing
batch records --- Support completion of deviations and
investigations related to manufacturing activities --- Support
cleaning and maintenance of laboratory equipment Desired
Skills/Qualifications: --- B.S./M.S. in a scientific discipline
with 2-4 years of relevant industry GMP manufacturing experience
(job level commensurate with experience) Aseptic tissue culture of
mammalian cells (pluripotent stem cells is a plus) ---
Manufacturing of clinical cell therapy product under GMP in a
controlled cleanroom environment --- Experience in upstream / cell
culture based manufacturing or development work --- Experience with
adherent cell culture preferred --- Experience with basic
bioprocessing operations (filtration set ups, single use mix
systems, tube welders) --- Understanding and application of good
documentation practices --- Ability to read and follow SOP's and
revise or author new SOP's as needed. --- Ability to communicate
effectively both verbally and in writing.
Qualifications
Bachelor' Degree in Cell Biology, Molecular Biology, Chemistry, or
related science, 2-4 years' experience in a GMP manufacturing
environment
Responsibilities
Manufacturing of clinical cell therapy product under GMP in a
controlled cleanroom environment
Maintain equipment and inventory for manufacturing and process
development operations
Testing and release of raw materials/new reagent lots and identify
and comparatively test alternative tissue culture material/reagent
sources
Process human primary materials for the isolation of MSC's
Perform cell culture activities to expand MSC's and manufacture
cell banks
Use good documentation practices to execute process batch
records
Collaborate with internal development team for the technical
transfer of new products into manufacturing
Draft, review and update SOP's and manufacturing batch records
Support completion of deviations and investigations related to
manufacturing activities
Support cleaning and maintenance of laboratory equipment
Keywords: BioRestorative Therapies, Inc., New Haven , GMP Cell Manufacturing Associate, Other , Melville, Connecticut
Click
here to apply!
|