Pfenex Inc.
  • 01-Nov-2018 to 31-Dec-2018 (PST)
  • San Diego, CA, USA
  • Full Time

Pfenex is a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value, difficult to manufacture proteins.We are committed to providing innovative solutions for global health. Our team is made up of driven, talented, motivated individuals making an immediate impact within our fast-paced dynamic organization

POSITION SUMMARY

 Serve as a member of the downstream process development team focused on early and late-stage development of downstream unit operations. Proficiency in all aspects of chromatography development is preferred. Experience with clarification techniques, such as continuous centrifugation, depth/membrane filtration is preferred. Position scope extends from bench to pilot-scale activities, experimental execution, data summarization and contributing to scientific report generation.  The candidate will participate in a purification development team and is expected to interact in a cross-functional environment, collaborating with various colleagues in process and product development.

ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES

Technical Scope

  • Demonstrated knowledge with multiple chromatography modes, and purification of recombinant proteins other than antibodies and tagged proteins.
  • Strong understanding of purification development of a drug substance process.
  • Develops purification process unit operations, including primary recovery, chromatography, and drug substance formulation.
  • Proactively troubleshoots and mitigates technical issues associated with primary recovery, chromatography processes, and formulation.
  • Individual contributor on scientific projects using current purification technologies while evaluating innovative approaches.
  • Executes experimental designs and participates in data analysis (JMP experience preferred).
  • Participates in activities of late stage purification process development and technology transfer to manufacturing.
  • Contributes to authorship of experimental protocols, executes laboratory experiments and authors reports in accordance with Good Documentation Practices and scientific principles.
  • Authors technical detailed development reports and provides input/data for manufacturing documents and regulatory submissions.
  • Gives presentations within the department and to senior management with minimal supervision.
  • Organizes and conducts meetings.
  • Ensures that safe laboratory practices are followed.
  • Trains junior level staff.
  • Participates in one or more project teams. 

JOB SKILLS, ABILITIES AND QUALIFICATIONS

BS in Physical, Chemical or Biological Sciences or Engineering or other applicable field

or BS    5 years of relevant industry experience

or MS    3 years of relevant industry experience

or PhD 1 years of relevant industry experience

  • Experience with multiple modes of chromatography (Affinity, ion exchange, hydrophobic interaction, mixed-mode).
  • Experience in product recovery/clarification, chromatography, filtration, PAT, and high throughput screening (HTS) technologies
  • Experience with AKTA chromatography systems and Unicorn software, as well as filtration methods including normal flow and TFF
  • Exceptional organizational skills
  • Experience with GDP, GLP & cGMP compliance and ISO9000
  • Exposure to cGMP manufacturing and CMC components of regulatory submissions.
  • Fluent in practical application of PC's, Microsoft Project, Word, Excel, PowerPoint
  • Experience with Statistical experimental design and analysis software a strong plus (e.g., JMP)
  • Ability to travel up to 10% (US and Internationally)
  • Ability to work flexible work schedules.
  • Proven ability to work in a lean organization and creatively solve problems.
  • Works independently with minimal supervision.

Additional Information 

  • Affirmative Action and Equal Opportunity Employer (EOE)
  • No agencies or phone calls please
  • Pfenex celebrates the diversity of life and welcomes all individuals to apply
  • Must be legally authorized to work in the US without sponsorship
Pfenex Inc.
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