Pfenex Inc.
  • 30-Oct-2018 to 29-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 required. Competency in clarification techniques, such as continuous centrifugation, depth/membrane filtration is preferred. Position scope extends from bench to pilot-scale activities, DOE planning/execution, data summarization and report generation. Individual technical issue management and effective communication are key position attributes. The candidate will participate on a Product Development Team in a cross-functional environment, collaborating with various colleagues in process and product development.

ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES

 Technical Scope

  • Strong understanding of protein characteristics and control strategies, and ability to direct purification development of a drug substance process.
  • Proactively troubleshoots and mitigates complex technical issues associated with primary recovery, chromatography processes, and formulation.
  • Initiates scientific projects using current purification technologies while evaluating innovative approaches.
  • Utilizes statistical experimental design and data analysis software (JMP experience preferred).
  • Conducts and directs late stage purification process development and technology transfer to manufacturing.
  • Develops experimental protocols, executes laboratory experiments and authors reports in accordance with Good Documentation Practice and scientific principles.
  • Authors technical detailed development reports and provides input/data for manufacturing documents and regulatory submissions.
  • Exposure to cGMP manufacturing and CMC components of regulatory submissions.

Leadership Scope

  • Demonstrated experience of collaboration and working through others.
  • Strong technical presentation skills, both written and verbal, to interact effectively with members of the Product Development Team, as well as external partners and service providers.
  • Actively creates and presents experimental designs, plans, and data summaries.
  • Potential to have direct reports and management responsibilities.
  • Ensures laboratory Safety practices/goals are followed and achieved

 

JOB SKILLS, ABILITIES AND QUALIFICATIONS

 

  • BS in Physical, Chemical or Biological Sciences or Engineering or other applicable field
  • or BS   8 years of relevant industry experience
  • or MS   6 years of relevant industry experience
  • or PhD 5 years of relevant industry experience
  • Demonstrated experience in drug substance development and/or process characterization.
  • 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
  • Scientific understanding of current purification technologies, as well as the ability to explore and develop novel approaches to further advance innovative purification technologies
  • Exceptional organizational skills
  • Proven working knowledge of GDP, GLP & cGMP compliance and ISO9000
  • Fluent in practical application of PC's, Microsoft Project, Word, Excel, PowerPoint as well as statistical experimental design and analysis software (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.
  • Work independently in a matrix environment and manage multiple tasks simultaneously.

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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