Process Development (PD) Associate, Downstream (Purification) - Abzena

Process Development (PD) Associate, Downstream (Purification)

Location: San Diego, CA
Area: Manufacturing

Position Responsibilities:

  • Assist the PD Associate Scientists and Scientists with the development work to develop scalable and robust processes on accelerated timelines.
  • Perform manufacturing and process development activities for projects and products in collaboration with others.
  • Assist with technical transfer of upstream or downstream manufacturing processes from clients and between Process Development and Manufacturing groups.
  • Specific duties will include demonstrated downstream/purification experience as follows:
  • Conduct protein and process characterization studies – Assist in production of purified proteins to support lead generation/optimization and preclinical studies
  • Assist with scale-up, optimization and technical transfer activities to appropriate manufacturing sites
  • Midstream (centrifugation)
  • Downstream (ion exchange/HIC/mixed mode/SEC/ affinity chromatography/TFF)
  • Filtration/extraction/precipitation/centrifugation
  • Generation of documents associated with new processes, ability to write & execute methods
  • Competent in affinity (Protein-A, SP, Q), size exclusion (GF), and weak/strong ion exchange chromatography column techniques
  • Associated techniques include buffer exchange, concentration (UF), viral and nano filtration
  • Perform materials request inventory
  • Programming experience on Unicorn
  • Protein characterization (Desired)
  • Weighs, measures and checks raw materials to assure proper ingredients and quantities.
  • Capable of making buffers following protocols and procedures.
  • Assist in manufacturing protein production and manufacturing of final products.
  • Assists in the documentation of observations and collecting data for analysis. Capable of data management.
  • Conduct activities in support of production schedules and objectives as directed by senior staff.
  • Maintains records to comply with regulatory requirements and assists with in-process testing.
  • Obtains and stock supplies as directed. Capable of inventory management.
  • Maintains records to comply with documentation requirements and assist with in-process testing.
  • Knowledge of quantitative analytical methods.
  • Represents departmental activities as needed, including project teams, training, and evaluation of new technologies

 

General Responsibilities:

  • Operates to the highest ethical and moral standards.
  • Complies with Abzena’s policies and procedures.
  • Adheres to quality standards set by regulations and Abzena’s policies, procedures and mission.
  • Communicates effectively with supervisors, colleagues and subordinates.
  • Ability to participate effectively as a team player in all aspects of Abzena’s business.
  • Travels as needed to attend professional conferences, and train on new technologies.

 

Qualifications/Skills Required:

  • AA/AS or BA/BS degree that included laboratory work in a chemistry, biology, chemical engineering or related field plus 1-3 years in a cGMP manufacturing/laboratory environment.
  • Basic knowledge of protein production and purification.
  • Skill with chromatography, ultrafiltration, normal flow filtration, and single-use technologies or cell culture parameters (for various cell lines) and nutrient requirement in shaker flasks and disposable bioreactors up to 25L for production.
  • Ability to conduct programming via Unicorn.
  • Ability to follow detailed instructions and to maintain accurate records and notes.
  • Ability to successfully perform multiple tasks, when required.
  • Skills in problem solving and troubleshooting.
  • Ability to safely operate production equipment in accordance with established practices.
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