Scientist IV

Job Title: Scientist IV
Job Location: Framingham, MA
Job Duration: 12 Months+

Pay range: $104/hr. on W2

Note:

• Slight flex with hours, some hybrid work may be offered at manager's discretion.
• Free parking at this site.
• Local candidates preferred, however open to candidates willing to relocate at own expense.
• Not a manufacturing support role, this is development.
• Scale up experience, tech transfer is a plus.
• Basic development of downstream.
• No cap max on years of exp.
• PHD's accepted.
• Possibility of extension.
• This role is involved in development (developing actual process) not manufacturing.

Must Have :

• Chromatography, TFF including, UD/DF, micro-filtration, nano filtration, and filtration
• 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.
• Process scaling and/or technology transfer experience.
• 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 including chromatography and filtration.
• Prior experience in process scaling and technology transfer.
• Prior experience with automated chromatography platforms (e.g., GE Healthcare AKTA).
• Experience with authoring and executing protocols, interpreting 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.
• Operating and troubleshooting process equipment.

Job Description:

• Downstream Process Development MSAT L2-2
• 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.

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