Pfenex Inc.
  • 11-Sep-2018 to 19-Feb-2019 (PST)
  • San Diego, CA, USA
  • Full Time

POSITION SUMMARY

 Responsible for resolving problems of diverse scope with regard to process optimization, scale-up and process transfer within the timelines and resource allocation.  This position is required to interface closely with various departments to ensure that scientific processes are compatible with overall project goals and timelines. The ideal candidate should have experience in microbial fermentation development, an understanding of strain or cell line engineering, and experience managing a team . 

ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES

Leadership Scope

  • Manage a team of senior scientists and/or technician level employees in experimental design/analysis and problem solving; manage work load/resourcing to support multiple programs
  • Generates and manages comprehensive budget and timelines for program project and department activities
  • Assembles and delivers CMC supporting regulatory documentation required to rationalize process controls, key indicators, and/or specifications
  • Represents upstream department in various departmental and interdepartmental committees that address functional, scientific, and/or industry initiatives
  • Collaborates effectively to achieve results as an individual as well as through others
  • Actively creates, generates, and presents papers/presentations at scientific meetings
  • With minimal supervision, generates and delivers concise/clear technical presentations to senior management
  • Keep informed of latest advancements in fermentation and related technologies, taking initiative to evaluate and present a case for acquisition of appropriate technologies to maintain Pfenex's state-of the art fermentation capability and to meet business needs.
  • Influence successful adoption of new technologies by working closely with senior leadership to identify new opportunities.
  • Document problems, solutions and innovations. Recognize and protect unique technology and facilitate broad adoption of intellectual property protection within function. Serve as mentor within function for filing invention disclosures to protect new technologies or inventions
  • Ensures laboratory Safety practices/goals are followed and achieved
  • Ensures PDT, individual, team, and corporate goals are achieved

Technical Scope

  • Serve as Fermentation subject matter expert in the development, scale-up, and transfer of processes across multiple scales of bioreactors.
  • As a single-point-of contact on the Product Development Team (PDT) and/or associated sub-teams, represents the Upstream department
  • Scientifically develops drug substance manufacturing fermentation processes and delivers material for further drug substance processing at lab, pilot, and commercial scales in a phase appropriate and compliant manner
  • Provides expertise, guidance, and direction on protein expression and critical attributes to direct effective fermentation development, scale-up and control strategies
  • Proactively troubleshoots and mitigates complex technical issues associated with process development and transfer collaboratively with the downstream processing team
  • Collaborates with the Technology Transfer department to ensure a smooth transfer/scale-up of the upstream process to the manufacturing facility
  • Supports process characterization design and analysis, and coordinates with the Technology Transfer team to ensure successful process qualification
  • Write technical documents and protocols that describe the operation of laboratory instruments/equipment or systems with sufficient details for successful transfer and scaling of processes to CMOs
  • Authors technical development detailed reports and provides input/data for regulatory submissions
  • Provides direct technical support to data packages for regulatory submission(s) as well as BLA, ANDA, and/or IND regulatory review meetings

JOB SKILLS, ABILITIES AND QUALIFICATIONS

 

  • BS/MS/PhD in Biology/Microbiology/Biochemistry/Biochemical Engineering or related field
  • BS 15 years of relevant experience w/a minimum of 10 years of industry exp
  • or MS   12 years of relevant experience w/a minimum of 8 years of industry exp
  • or PhD 7 years of relevant industry experience w/a minimum of 5 years of industry exp
  • >5 years of biosimilar and/or pharmaceutical process development/ characterization, and/ or clinical/ commercial manufacturing experience required
  • Travel will be required to assist the transfer of a process (up to 25%).
  • Flexible hours essential, be available to troubleshoot equipment and process issues during off-hours
  • Must have working knowledge of GLP compliance, ISO9000, and cGMP regulatory guidelines
  • Must be fluent with PC's, MS Office suite (Word, Excel, PowerPoint), statistical experimental design and different process control/operating software.
  • Innovative approach to problem-solving, an integrated view of business/scientific issues, and a strong work ethic.
  • Possesses and demonstrates exceptional problem solving skills.
  • Proven ability to work in a lean organization and creatively tackle problems.
  • Work independently in a matrix environment and manage multiple tasks simultaneously.
  • Other skills and abilities as required
Pfenex Inc.
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