Associate Scientist, Biologics Purification Process Development

Job Locations US-NJ-Florham Park
ID
2020-1253
Category
Process Development / CMC
Type
Regular Full-Time

Overview

We are looking for a motivated Biologics Purification Process Development Associate Scientist to join our Process Development group to contribute to the development and optimization of large molecule purification processes for clinical stage cell therapy and/or biologics products. This position requires hands-on execution of process development, optimization, and improvements, along with process characterization of biologics purification processes that can be transferred to the manufacturing operations team. Furthermore, this individual is expected to work both independently on assigned tasks/projects and/or collaboratively within a matrix team setting, and provide insight to improve processes and communicate results to the CMC team.

 

Ideal candidates will have demonstrated process development experience in biologics and/or cell therapy purification will be detail-oriented with excellent organization, documentation and communication skills.

Responsibilities

  • Develops scalable, robust, high yielding, and economically viable biologics purification processes using knowledge and experiences in chromatography, Tangential Flow Filtration, Depth Filtration, ultracentrifugation, and other purification techniques in the process development laboratory setting.
  • Designs and performs experiments to develop the purification process, identify key operational parameters, and establish their relationship to quality attributes through Design of Experiments.
  • Perform process scale-up and establish a scale-down model.
  • Executes experiments, analyzes and interprets data to recommend and make process improvements.
  • Executes process monitoring and control strategies for robust process design.
  • Collaborates and coordinates material needs with colleagues from other departments
  • Provides investigative support for cGMP manufacturing of pre-clinical and clinical study materials
  • Reviews process descriptions and batch records during tech transfer or regular change control process.
  • Keeps current with advances in downstream processes targeting at further automation and improved yields.
  • Assist in drafting relevant CMC sections for regulatory filing.

Qualifications

  • A minimum of a bachelor’s degree in Biological Sciences, Biotechnology, Chemical Engineering, or other related fields with 5+ years of academic and/or industrial lab experience, or a Master degree with 3+ years industrial experience.
  • Experience with biologics purification and characterization combined with an excellent understanding of therapeutic proteins is required.
  • Experience with AKTA systems, chromatograph, membrane filtrations, and HPLC is required.
  • Experience with DoE software and application is required.
  • Knowledge and experience in viral inactivation and removal.
  • Excellent record keeping abilities to adequately document process development data
  • Detail-oriented and able to prioritize assignments
  • Strong verbal and written communication skills
  • Ability to maintain an electronic lab notebook

Preferred Skills

  • Hands-on experience working with viral vectors, and exosomes.
  • Experience in scale-up and improving scalable downstream processes in PD setting.
  • Experience in transferring the process to MFG.
  • Familiarity with FDA guidance and GMP/quality systems

Additional Notes

  • Must be familiar with BSL-II lab safety requirements.

Role will be filled commensurate with experience.

 

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