Pfenex Inc.
  • 30-Oct-2018 to 29-Mar-2019 (PST)
  • San Diego, CA, USA
  • Full Time

Pfenex is a clinical stage development and licensing biotechnology company focused on leveraging our
Pfenex Expression Technology platform to develop and improve protein therapies for unmet patient needs. Our dynamic team is comprised of talented individuals who bring passion to our purpose and commitment to the cause.

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.
  • Apply Now

  • * Fields Are Required

    What is your full name?

    How can we contact you?

    I agree to ApplicantPro's Applicant Information Use Policy.*
  • Sign Up For Job Alerts!

  • Share This Page
  • Facebook Twitter LinkedIn Email
.

Image Map

Logo Home About Our Biosimilars Our Vaccines Our Position Investors Contact