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