What are the responsibilities and job description for the Scientist, Downstream Process Development in MSAT position at Randstad Life Sciences US?
1 Year Contract
Framingham, MA
PR: $100-110/hr
Shift: M-F 9am-5pm- Fully Onsite
Job Description
The Scientist, Downstream Process Development in MSAT will work in a matrix team management environment with global engineers and scientists to achieve robust and scalable purification processes to support 2nd generation processes, late-stage programs, and life-cycle management. This position will support the development of purification processes for a wide variety of molecules and modalities.
Job 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.
- Manage an MSAT development team, including regular team meetings and updates, data management, investigations, technical report writing, and regulatory filings. Help to develop Junior staff
- Manage virus clearance studies to support regulatory filings
- Manage Process characterization studies, DOE studies to establish proven and acceptable process ranges., development of small-scale models, Impurity Clearance studies
- Manage technology transfer for internal and external partners.
Education & Qualifications
Required:
- Ph.D. in Biotechnology, or related field, with a minimum of 3 to 5 years of relevant experience
- If no PhD, would accept a M.S./M.A. in Biotechnology, or related field, with a minimum of 5 to 10 years of relevant experience
- If no higher education, would accept a B.S./B.A. in Biotechnology, or related field, with a minimum of 10 years of relevant experience
- Prior experience with
- Chromatography
- TFF including, UD/DF, micro-filtration, nano filtration, and filtration
- Automated chromatography platforms (e.g., GE Healthcare AKTA).
- Authoring and executing protocols.
- Interpretation of data, and report generation.
- Operating and troubleshooting process equipment.
Preferred:
- Virus clearance studies
- Experience with downstream processes at the small to an intermediate scale of cGMP biologics production.
- Prior experience in process scaling and/or technology transfer.
Salary : $100 - $110
