Scientist III

Company : Integrated Resources, Inc

Job Title: Scientist III
Job Location: Framingham, MA
Job Duration: 12 Months (possibility of extension)
Payrate: $84.00/ hr on w2

Job Summary:

• 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 & 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-, fusion proteins, enzymes, and other recombinant proteins to support GMP manufacture.
• Work on MSAT development and pilot-scale projects, including regular team meetings and updates for, data management, investigations, technical report writing, and regulatory filings.
• Ability to overcome challenges, with creative and innovative solutions.
• Support the Develop and implement new cutting-edge technologies, for DSP sciences for life cycle management projects.
• Support technology transfer including projects for internal and external partners.
• Support DOE studies to establish proven and acceptable ranges (PAR) for process characterization.

Basic Requirements/ Qualifications:

• M.S./M.A. in Biotechnology, or related field, with a minimum of 3+ years of relevant experience.
• B.S./B.A. in Biotechnology, or related field, with a minimum of 5+ years of relevant experience.
• Preferred experience with Commerical Downstream Manufacturing Support.
• Downstream processes at the small to an intermediate scale of cGMP biologics production.
• Chromatography, TFF including, UD/DF, micro filtration, nano filtration, and filtration
• Process scaling and/or technology transfer.
• Virus clearance studies
• Automated chromatography platforms (e.g., Client Healthcare AKTA).
• Authoring and executing protocols, interpretation of data, and report generation.
• Operating and troubleshooting process equipment.

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