Pfenex Inc.
  • 17-Sep-2018 to 16-Mar-2019 (PST)
  • San Diego, CA, USA
  • Full Time


Reporting directly to the VP Global Quality, as a key member of the Quality Organization, the Director of Quality Assurance/Quality Control (QA/QC) is responsible for Quality Assurance/Quality Control Operations (QA/QC) in support of PFEnex products. Strong QA/QC experience in biosimilar and recombinant vaccine biopharmaceutical environment from research and development to commercial. Interface closely with various departments to ensure that QA/QC related activities at PFEnex, PFEnex partners or service providers are properly managed to support process/method transfer, disposition of products, achieve project goals, and timelines. This position presents a great opportunity to be part of a team that drive the company Quality Culture and continuous improvement and support the advancement of a broad portfolio of biosimilar products and recombinant vaccines. We are interested in candidates with a proven track-record of successfully and efficiently integrating activities and perspectives across functions to achieve our ultimate goal of delivering Quality cost effective therapies that enable access to patients who need them.


  • Actively, support in the development of the long-term Quality strategy for Pfenex business model and overall quality oversight. Be flexible, transition from strategy to tactical activities.
  • Actively support, develop and drive Pfenex Quality Culture by embedding quality into business processes which support GCP, GLP, GMP's including suppliers, external CMO's, CRO's and Contract Laboratories.
  • Develop continuous improvement plan, establish metrics and facilitate review at Quality Operations Review
  • Provide Quality oversight to contract manufacturer/contract laboratories, identify GxP quality risks and present integrated risk management solutions to senior leadership teams.
  • Act as Person in the Plant for Pfenex CMO's, if applicable.
  • Collaborate and partner with Process Development, Analytical and Manufacturing Team, Program Management Office, Regulatory and CMC in support of product pipeline and registration activities.
  • Provide strategic leadership and coaching to direct reports in the execution of their functions. Attract, develop and lead a high performing, global and diverse team to support Pfenex
  • Direct and Approve and/or generate GxP documents, technical transfer, Specifications, Validation documents, Method Validations, Risk Assessments, Change Control, Deviations, OOS, Master Batch Records and product disposition.
  • Manage regulatory inspection or Board of Health communication and partner to support CMC related activities in Quality response preparations. Proactively lead inspections readiness program and prepare for pre-approval inspections.
  • Ensure that the in-process analytics and quality control comply with regulatory requirement
  • Generate COAs as needed for Pfenex products; oversee revisions
  • Work with analytical function to determine product release assays; review release assay data
  • Oversee Reference Standard documentation and characterization plan; determine primary and secondary references; new reference bridging plan; reference stability
  • Oversee CMO/partner QC analytical cGMP activities: review SOPs, validation protocols, validation reports, verification protocols, verification reports; method transfer protocols for validated methods; ensure data integrity
  • Other duties as assigned or required.


A minimum of a Bachelor's of Science degree in life sciences or other relevant biologic, chemistry, biochemistry discipline required; Master's degree preferred.

  • 10+ years of Pharmaceutical/Biopharmaceutical Quality, Compliance, Quality Control experience in support of clinical/commercial manufacturing of Biologics, Sterile Fill Finish, combination products and/or device  required
  • 5+ years of managing, leading and developing others required
  • Knowledgeable of GxP environment cGMP, GLP, GCP environments and regulations experience required.
  • Knowledgeable of US standards 21CFR210, 21CFR211, 21CFR11 and ICH Quality Guidelines
  • Manage Regulatory Board Inspections, FDA, EMEA, PMDA, etc.
  • ASQ, Black Belt/Green Belt certifications a plus.
  • Ability to travel up to 25% (US and Internationally)
  • Ability to work flexible work schedules.
  • Excellent computer, verbal, and written communication skills
  • Innovative approach to problem-solving, an integrated view of business/scientific issues, and a strong work ethic.
  • Proven ability to work in a lean organization and creatively tackle problems.
  • Work independently in a matrix environment and manage multiple tasks simultaneously.
  • Experience in process characterization within biosimilars process development organization
  • Experience with biopharmaceutical product PD, research, clinical, and commercial manufacturing
  • Significant experience with MS Office Suite; Project, Visio, LIMS, and EDMS.
  • Experience with analytical process characterization techniques (HPLC, ELISA, SDS-PAGE and CE).
  • Working knowledge of U.S. Government-funded programs is preferred
  • Other skills and abilities as required

 Additional Information:

*All new hires are required to go through a background and reference check
*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
*Pfenex does not currently offer sponsorship or consideration to those on an H1-B or other similar visas at this time


Pfenex Inc.
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