Scientist

Description

Fully Onsite

• 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 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.
• Operating and troubleshooting process equipment

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.

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., 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.