Duration: 12 Months+ (High possibility of extension)
The Associate 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 Company’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 Company 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.
- 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
- M.S./M.A. in Biotechnology, or related field, with a minimum of 1+ years of relevant experience; OR
- B.S./B.A. in Biotechnology, or related field, with a minimum of 3+ years of relevant experience.
- 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
- Authoring and executing protocols, interpretation of data, and report generation.
- Operating and troubleshooting process equipment.
- Upstream or Cell Culture Experience.
- Downstream or Purification Experience.
- Strong understanding of the purification process and industry systems.
- Lab Experience with Protein purification.
- Experience specific to technical duties, must be lab-focused experience (if just process or manufacturing only, this is limited).
- Team Player Nice to Have/Strongly Preferred:
- GMP strongly preferred.
- JUMP Analysis.
- DOE Experience (Design of Experiments).