Scientist II

Company: Planet Pharma
Location: Framingham
Posted on: June 1, 2021

Job Description:

Responsibilities:

• Work with a global group of engineers and scientists to develop robust and scalable downstream processes for monoclonal antibodies, bispecific antibodies, Fc-, Fab-, and fusion proteins, enzymes, and other recombinant proteins to support GMP manufacture.

Work may include some of the following

• Work on MSAT development and pilot-scale projects, to include regular team meetings and updates for, data management, investigations, technical report writing and regulatory filings.
• Support virus clearance studies to support regulatory filings
• Support of scale-down model development and qualification
• Support technology transfer including projects for internal and external partners.
• Support DOE studies to establish proven and acceptable process ranges.

Requirements:

• PhD in Biotechnology, or related field, with minimum of 0 to 3 years of relevant experience; or * M.S./M.A. in Biotechnology, or related field, with minimum of 3 to 5 years of relevant experience; or B.S./B.A. in Biotechnology, or related field, with minimum of 5+ years of relevant experience.

Ideally experience in some of the areas listed below

• Experience with downstream processes at the small to intermediate scale of cGMP biologics production including chromatography and filtration.
• Prior experience in process scaling and or technology transfer
• Prior experience with automated chromatography platforms (e.g. GE Healthcare AKTA)
• Experience with authoring and executing protocols, interpretation of data and generating final reports
• Process-scale chromatography and filtration including nano, tangential flow, and normal flow filtration
• Experience writing and revising standard operating procedures and batch production records
• Experience with operating and troubleshooting process equipment * Experience working on late phase and commercial programs

Keywords: Planet Pharma, Framingham , Scientist II, Other , Framingham, Massachusetts