Process Development (PD) Associate, Downstream (Purification)
Location: San Diego, CA
- 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)
- 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
- 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.
- 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.