cGMP Bioreactor Supervisor

 

A biotechnology company is seeking a cGMP Bioreactor Supervisor.  The position is based in Ft. Lauderdale, FL. They are seeking a highly self motivated and enthusiastic supervisor to work within the upstream area of a busy manufacturing/development department.  You will be required to work on variety of cell lines being manufactured developed simultaneously.

 

Position Summary:  Supervisor, the position involves the operation and maintenance of all equipment within an upstream Manufacturing and Development environment.  Equipment includes stirred bioreactors up to 500L, packed bed bioreactors up to 10L, Hollow fiber bioreactors and all standard pre-culture equipment.

 

 

Position Responsibilities

 

1) Ensure equipment is Prepared and operated according to SOP’s, including the preparation and sterilization of bioreactors and process equipment.

2) Daily monitoring of online/offline bioreactor parameters.

3) Maintenance of bioreactors according to maintenance program or changeover requirements, and maintain manufacturing inventory

4) Complete all cGMP documentation diligently and report any deviations to management and ensure they are closed out in a timely manner.

5) Drive the writing and execution of qualification IOPQ’s

6) Drive the writing of new batch records, specifications, SOP’s, according to process descriptions

7) Organize and prepare sterile buffers and media

8) Any other tasks deemed necessary for manufacturing.

9) Must be able to multi task projects

10) Person will constantly interact with QA,QC, Materials Management

 

Position Requirements

 

1)  BSc/Associates degree, in a relevant field (biology, biotechnology, chemical engineering etc)

2)  Experience in a biotech cGMP environment

3)  4 years cGMP Biotechnolgy experience is required, previous CMO experience is preferred and previous supervisory responsibilities is essential.

4)  Must be able to work weekends and to be on an emergency call out schedule (once fully trained) to cover projects as required.