Scientist IV

Job Title: Scientist IV- Downstream Process Development
Location: Framingham, MA, (On Site)
Duration:12 Months+ (Possibility of Extension)

Pay range: $104.00/hr.- $111.00/hr on W2

Description:
Downstream Process Development MSAT

• 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.
• In concert with Client’s Patient First philosophy, this role will play a key role in developing robust and scalable protein purification processes to deliver to the manufacturing group. As part of the MSAT group, this position will also support the manufacturing team to ensure the successful technology transfers to produce pharmaceutical drugs for life-saving therapies.
• The drug substance function within global Manufacturing Science & Analytical Technology (MSAT) is the owner of Life Cycle Management (LCM) of DS Processes within the Client biologics manufacturing network. We deliver innovative, robust, and cost-effective next-generation processes and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gap assessment, process validation, preparing dossier sections, & PAI support to enable the launch of new and LCM products. Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting the launch of 20 new products in the next 5 years including monoclonal and multi-specific antibodies, fusion protein, antibody-drug conjugate, synthorins, and nanobodies. In recent years we have successfully established second-generation manufacturing processes with a continuous process platform. We are pursuing future innovations such as digital labs, factories of the future, and advanced analytics-based process understanding and control.

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.

BASIC REQUIREMENTS/QUALIFICATIONS:
• Ph.D. in Biotechnology, or related field, with a minimum of 3 to 5 years of relevant experience; OR
• M.S./M.A. in Biotechnology, or related field, with a minimum of 5 to 10 years of relevant experience; OR
• B.S./B.A. in Biotechnology, or related field, with a minimum of 10+ years of relevant experience

DESIRABLE, BUT NOT REQUIRED:
• Experience with downstream processes at the small to an 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., Client 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.
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